Company · US
Roche Diagnostics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2026. Name variants (Inc, Corp, punctuation) are merged.
463510(k) clearances (15 in 12 months)
240recalls (0 in 12 months)
191recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 60 |
| LFR | Glucose Dehydrogenase, Glucose | 49 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 42 |
| NBW | System, Test, Blood Glucose, Over The Counter | 27 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 26 |
| CGA | Glucose Oxidase, Glucose | 23 |
| GJS | Test, Time, Prothrombin | 22 |
| JIT | Calibrator, Secondary | 18 |
| JIX | Calibrator, Multi-Analyte Mixture | 16 |
| LZG | Pump, Infusion, Insulin | 15 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 11 |
| CEM | Electrode, Ion Specific, Potassium | 10 |
| DKZ | Enzyme Immunoassay, Amphetamine | 10 |
| NPQ | Test, Factor V Leiden Mutations, Genomic Dna Pcr | 10 |
| MMI | Immunoassay Method, Troponin Subunit | 9 |
| CGN | Acid, Folic, Radioimmunoassay | 8 |
| LCP | Assay, Glycosylated Hemoglobin | 8 |
| CFR | Hexokinase, Glucose | 7 |
| DKB | Calibrators, Drug Mixture | 7 |
| JZO | System, Test, Thyroid Autoantibody | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 2026 | DEN260027 | Elecsys HBsAg II quant II RxDx Roche Diagnostics | SJM |
| Oct 2, 2026 | K260233 | Elecsys EBV IgM Roche Diagnostics | LJN |
| Oct 2, 2026 | K260232 | Elecsys EBV VCA IgG Roche Diagnostics | LSE |
| Oct 2, 2026 | K260221 | Elecsys EBV EBNA IgG Roche Diagnostics | LSE |
| Aug 19, 2026 | K261686 | Elecsys Phospho-Tau (217P) Plasma Roche Diagnostics | SET |
| Jun 12, 2026 | K252323 | cobas pulse blood glucose monitoring system Roche Diagnostics | PZI |
| Apr 24, 2026 | K252431 | Elecsys Calcitonin Roche Diagnostics GmbH, DE | JKR |
| Apr 13, 2026 | K252280 | Elecsys Anti-SARS-CoV-2 S Roche Diagnostics | QVP |
| Apr 7, 2026 | K260049 | Elecsys Anti-HBc IgM Roche Diagnostics | SEI |
| Apr 7, 2026 | K260048 | Elecsys Anti-HAV IgM Roche Diagnostics | LOL |
| Apr 7, 2026 | K260046 | Elecsys Anti-HBc II Roche Diagnostics | SEI |
| Apr 2, 2026 | K260026 | Tina-quant Cardiac high sensitivity CRP III Roche Diagnostics | NQD |
| Feb 12, 2026 | K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions Roche Diagnostics | CEM |
| Feb 12, 2026 | K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions Roche Diagnostics | CFR |
| Dec 17, 2025 | K253839 | Elecsys Anti-SARS-CoV-2 Roche Diagnostics | QVP |
| Oct 24, 2025 | K253188 | CoaguChek XS Plus System Roche Diagnostics | GJS |
| Oct 8, 2025 | K252163 | Elecsys Phospho-Tau (181P) Plasma Roche Diagnostics | SET |
| Jul 17, 2025 | K242505 | Elecsys Cortisol III Roche Diagnostics | JFT |
| Jun 10, 2025 | K250768 | Elecsys Anti-SARS-CoV-2 Roche Diagnostics | QVP |
| Feb 7, 2025 | K241453 | Elecsys sFlt-1 and Elecsys PlGF Roche Diagnostics | QWH |
| Jun 17, 2024 | K233060 | Elecsys Folate III Roche Diagnostics | CGN |
| Apr 26, 2024 | K220272 | cobas pulse blood glucose monitoring system Roche Diagnostics | PZI |
| Mar 22, 2024 | K231927 | Elecsys PTH , Elecsys PTH STAT Roche Diagnostics | CEW |
| Sep 30, 2023 | K221890 | Elecsys Tg II Roche Diagnostics | MSW |
| Sep 15, 2023 | K222610 | Elecsys Anti-Tg Roche Diagnostics | JZO |
| Jul 21, 2023 | K223637 | Elecsys proBNP II, Elecsys proBNP II STAT Roche Diagnostics | NBC |
| Jun 5, 2023 | K231348 | Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF Roche Diagnostics | QSE |
| Apr 7, 2023 | K220456 | Elecsys FT4 IV Roche Diagnostics | CEC |
| Mar 30, 2023 | K230161 | ONLINE TDM Phenytoin - Free Phenytoin application Roche Diagnostics | MOJ |
| Jan 4, 2023 | K221693 | Elecsys Anti-HCV II (08837031190) Roche Diagnostics | MZO |
| Dec 23, 2022 | K221765 | ONLINE DAT Benzodiazepines II Roche Diagnostics | JXM |
| Dec 7, 2022 | K221842 | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF Roche Diagnostics | QSE |
| Oct 12, 2022 | K220924 | Elecsys HSV-2 IgG (08948887160) Roche Diagnostics | MYF |
| Oct 12, 2022 | K220923 | Elecsys HSV-1 IgG (08948844160) Roche Diagnostics | MXJ |
| Oct 12, 2022 | K220911 | Elecsys CMV IgG Roche Diagnostics | LFZ |
| Sep 16, 2022 | K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH Roche Diagnostics | CFR |
| Sep 15, 2022 | K220176 | Elecsys AFP Roche Diagnostics | LOJ |
| Jun 10, 2022 | K203757 | Elecsys AMH Roche Diagnostics | PQO |
| May 6, 2022 | K211685 | Elecsys Testosterone II Roche Diagnostics | CDZ |
| Mar 31, 2022 | K210546 | Elecsys proBNP II, Elecsys proBNP II STAT Roche Diagnostics | NBC |
| Sep 21, 2021 | K201441 | Elecsys Troponin T Gen 5 Roche Diagnostics | MMI |
| Sep 1, 2021 | K210901 | Elecsys Vitamin D total III Roche Diagnostics | MRG |
| Aug 18, 2021 | K203227 | Elecsys HCG STAT Roche Diagnostics | DHA |
| Jul 20, 2021 | K211302 | Elecsys Syphilis Roche Diagnostics | LIP |
| Nov 6, 2020 | K200811 | cobas u 701 microscopy analyzer Roche Diagnostics | LKM |
| Mar 9, 2020 | K192815 | Elecsys BRAHMS PCT Roche Diagnostics | PRI |
| Feb 27, 2020 | K193313 | Elecsys Anti-TSHR Roche Diagnostics | JZO |
| Aug 16, 2019 | K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions Roche Diagnostics | CFR |
| Aug 13, 2019 | K190428 | Elecsys Anti-HAV II Roche Diagnostics | LOL |
| May 7, 2019 | K183432 | cobas u 601 urinalysis test system Roche Diagnostics | JIL |
Newest 50 of 463.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2019 | Roche Diagnostics Corporation cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval. Terminated |
JQP | None listed |
| Jul 3, 2019 | Roche Diagnostics Corporation cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval. Terminated |
JQP | None listed |
| Jun 3, 2019 | Roche Diagnostics Corporation The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. Terminated |
CZP | K040435 |
| Apr 13, 2019 | Roche Diagnostics Corporation Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190
Product Usage:
Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and pl Terminated |
DAQ | K040431 |
| Apr 13, 2019 | Roche Diagnostics Corporation Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190,
***added as of 5/10/19*** 03183700190
Product Usage:
An In vitro diagnostic reagent system intended for use on cobas Integra for t Terminated |
KHP | K964457 |
| Apr 13, 2019 | Roche Diagnostics Corporation Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160
***added as of 5/10/19***05795397190, 05795648190
Product Usage:
In vitro test for the quantitative d Terminated |
CIG | K131544 |
| Mar 18, 2019 | Roche Diagnostics Corporation Albumin BCP
Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems. Terminated |
CJW | K844426 |
| Mar 15, 2019 | Roche Diagnostics Corporation cobas e 801 immunoassay analyzer Terminated |
JJE | K100853 K162606 +1 |
| Feb 4, 2019 | Roche Diagnostics Corporation Cobas infinity central lab IT solution
Material Number: 07154003001
Calculator/Data Processing Module, For Clinical Use Terminated |
JQP | None listed |
| Dec 17, 2018 | Roche Diagnostics Corporation Anti-HAV IgM test System, Material No. 11820591160
Product Usage:
The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (ant Terminated |
LOL | K093955 |
| Dec 14, 2018 | Roche Diagnostics Corporation cobas c 111 with ISE analyzers analyzer used in the following assays:
a)Creatinine plus ver.2
Catalog Number: 05401470190;
b)Triglycerides
Catalog Number: 04657594190 - Product Usage: Tina-quant Ap Terminated |
JJE | K024098 K873049 |
| Dec 14, 2018 | Roche Diagnostics Corporation COBAS INTEGRA 400 plus analyzer used in the following assays:
a)Tina-quant Apolipoprotein A-1 ver.2
Catalog Number: 03032566122
b)Tina-quant Albumin Gen.2
Catalog Number 04469658190
c)Creatinine p Terminated |
JJE | K013249 K101203 |
| Nov 2, 2018 | Roche Diagnostics Corporation CoaguChek XS System Prothrombin time test:
CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160;
CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160;
CoaguChek XS PT Test 24 Tests, Cat Terminated |
GJS | K071041 K093460 +2 |
| Sep 24, 2018 | Roche Diagnostics Corporation Roche Diagnostics URISYS 1100 Urine Analyzer
Part Number: 03617556001
Product Usage:
The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results Terminated |
KHE | K033548 |
| Jul 16, 2018 | Roche Diagnostics Corporation Roche cobas p 612 pre-analytical system (63x)
Model: 07563116001
The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and cen Terminated |
JQP | None listed |
| May 3, 2018 | Roche Diagnostics Corporation cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measuremen Terminated |
CEM | K032311 |
| May 3, 2018 | Roche Diagnostics Corporation cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measureme Terminated |
CEM | K032311 |
| May 3, 2018 | Roche Diagnostics Corporation Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurem Terminated |
CEM | K032311 |
| May 3, 2018 | Roche Diagnostics Corporation cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measuremen Terminated |
CEM | K032311 |
| Apr 27, 2018 | Roche Diagnostics Corporation Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160
Product Usage:
This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and Terminated |
MRG | K162840 |
| Apr 27, 2018 | Roche Diagnostics Corporation Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190
Product Usage:
This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and Terminated |
MRG | K162840 |
| Apr 3, 2018 | Roche Diagnostics Corporation cobas e 801 immunoassay analyzer, cobas 8000 Modular Series
The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is par Terminated |
JJE | K100853 K162606 +1 |
| Jan 16, 2018 | Roche Diagnostics Corporation Brand Name:
cobas c 6000 MODULAR Series System e 601
cobas c 8000 MODULAR Series System - e 602
Roche / Hitachi MODULAR Analytics Combination System
Model/Catalog/Part Number:
MODULAR Analytics Terminated |
JJE | K060373 K100853 +1 |
| Jan 2, 2018 | Roche Diagnostics Corporation Roche Acetaminophen assay
03255379160-HAcetaminophen (P)
20767174160- cobas c Integra AAcetaminophen150 test Terminated |
LDP | K110726 |
| Dec 22, 2017 | Roche Diagnostics Corporation Elecsys BRAHMS PCT
Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin). Terminated |
PMT | K160729 |
| Dec 18, 2017 | Roche Diagnostics Corporation cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for
Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk Terminated |
JJE | None listed |
| Dec 18, 2017 | Roche Diagnostics Corporation Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry
(Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692,
03023109001, 05023599001, 05023572001, 03739040001 & 030231099 Terminated |
JJE | K953239 |
| Dec 18, 2017 | Roche Diagnostics Corporation c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692 Terminated |
JJE | K060373 |
| Jul 28, 2017 | Roche Diagnostics Corporation Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001 Terminated |
JJE | K100853 |
| Jul 18, 2017 | Roche Diagnostics Corporation cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module Terminated |
JJE | K100853 |
| Jul 18, 2017 | Roche Diagnostics Corporation cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 058 Terminated |
JJE | K060373 |
| Jul 5, 2017 | Roche Diagnostics Corporation Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyz Terminated |
JJE | K961481 |
| Jul 5, 2017 | Roche Diagnostics Corporation cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device Terminated |
JJE | None listed |
| May 31, 2017 | Roche Diagnostics Corporation Elecsys PreciControl Varia 3 Terminated |
JJY | K111506 |
| May 9, 2017 | Roche Diagnostics Corporation Cobas connection module (CCM) - OUTPUT UNIT
The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi Terminated |
JQP | None listed |
| Mar 23, 2017 | Roche Diagnostics Corporation Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx Terminated |
JQP | None listed |
| Mar 23, 2017 | Roche Diagnostics Corporation Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Terminated |
JQP | None listed |
| Mar 21, 2017 | Roche Diagnostics Corporation Sample probes associated with:
cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer
cobas c 501/502
cobas c 701/702
cobas 8000 ISE
Product Usage:
The cobas 6000 series Terminated |
JJE | K060373 K100853 |
| Jan 24, 2017 | Roche Diagnostics Corporation cobas p 612 pre-analytical system;
Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis. Terminated |
JQP | None listed |
| Sep 16, 2009 | Roche Diagnostics Corp. Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN.
Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as Terminated |
NBW | K070585 |
| Sep 16, 2009 | Roche Diagnostics Corp. Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN.
Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as Terminated |
NBW | K070585 |
| Sep 10, 2009 | Roche Diagnostics Corp. Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190.
Calibrator designed for the calibration of Roche assays for the quantitative determination of certain d Terminated |
DKB | K031856 |
| Sep 10, 2009 | Roche Diagnostics Corp. Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 190.
Calibrator designed for the calibration of Roche assays for the quantitative determination of certain dr Terminated |
DKB | K031856 |
| Aug 11, 2009 | Roche Diagnostics Corp. Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137001, 05177294001 and 05079241001 include the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Dia Terminated |
LFR | K040796 |
| Aug 11, 2009 | Roche Diagnostics Corp. Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indian Terminated |
GJS | K062925 |
| Aug 11, 2009 | Roche Diagnostics Corp. Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3 Terminated |
LFR | K060620 |
| Aug 11, 2009 | Roche Diagnostics Corp. Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3 Terminated |
LFR | K982079 |
| Aug 11, 2009 | Roche Diagnostics Corp. Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model Terminated |
LFR | K021827 |
| Aug 11, 2009 | Roche Diagnostics Corp. Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models 3144844001 (10 lancets) and 3583031002 (17 lancets).
The device is used to prick the finger and to Terminated |
FMK | None listed |
| May 20, 2009 | Roche Diagnostics Corp. Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager Server as follows: v.8.04.02.10, catalog no. 04785568001; v.8.04.03.01, catalog Terminated |
JQP | None listed |
Newest 50 of 240.