Company ยท US
Roche Diagnostics Operations, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2025. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
151recalls (2 in 12 months)
115recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 28 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 19 |
| FPA | Set, Administration, Intravascular | 12 |
| GJS | Test, Time, Prothrombin | 10 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 6 |
| NBW | System, Test, Blood Glucose, Over The Counter | 6 |
| MMI | Immunoassay Method, Troponin Subunit | 4 |
| LCD | Enzyme Immunoassay, Gentamicin | 3 |
| LEH | Radioimmunoassay, Vancomycin | 3 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| CHP | Radioimmunoassay, Estradiol | 2 |
| CIC | Cresolphthalein Complexone, Calcium | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 |
| DDG | Transferrin, Antigen, Antiserum, Control | 2 |
| JZO | System, Test, Thyroid Autoantibody | 2 |
| KPA | Slide Stainer, Automated | 2 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| LDP | Colorimetry, Acetaminophen | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 24, 2025 | K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity Roche Diagnostics Operations | DFC |
| Feb 20, 2024 | K233454 | ONLINE TDM Methotrexate Roche Diagnostics Operations | LAO |
| Jul 28, 2017 | K163633 | cobas HbA1c Test, cobas b 101 system Roche Diagnostics Operations | LCP |
| Oct 11, 2013 | K131366 | ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics Operations, Inc. | LFR |
| Aug 9, 2013 | K131029 | ACCU-CHEK AVIVA PLUS TEST STRIP Roche Diagnostics Operations, Inc. | NBW |
| Aug 8, 2013 | K121610 | COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY Roche Diagnostics Operations | PDJ |
| May 14, 2012 | K113072 | TINA-QUANT ALBUMIN GEN.2 Roche Diagnostics Operations | DCF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2026 | Roche Diagnostics Operations, Inc. cobas pro integrated solutions with cobas c 503 analytical units:
cobas pro sample supply unit, material number 08464502001
cobas pro SSU, material number 09205632001
Affected Assays:
(Product Name Open, Classified |
JJE | K191899 |
| Jan 2, 2026 | Roche Diagnostics Operations, Inc. The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretre Open, Classified |
JZO | K193313 |
| Nov 19, 2024 | Roche Diagnostics Operations, Inc. cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine Open, Classified |
LPS | K113793 |
| Sep 20, 2024 | Roche Diagnostics Operations, Inc. Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma.
Catalog Number: 07190794 Open, Classified |
JHS | K160570 |
| Nov 20, 2023 | Roche Diagnostics Operations, Inc. Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503) Open, Classified |
GHH | K062203 |
| Jan 12, 2023 | Roche Diagnostics Operations, Inc. cobas infinity central lab, Material Number 07154003001 Open, Classified |
JQP | None listed |
| Jul 14, 2022 | Roche Diagnostics Operations, Inc. cobas e801 Immunoassay Analyzer Open, Classified |
JJE | None listed |
| Oct 18, 2021 | Roche Diagnostics Operations, Inc. Cobas u 601 urinalysis test system, Catalog number 06334601001
The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyz Terminated |
KQO | K183432 |
| Jun 24, 2021 | Roche Diagnostics Operations, Inc. cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001 Terminated |
JQP | None listed |
| Apr 26, 2021 | Roche Diagnostics Operations, Inc. IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi Open, Classified |
JJE | K951595 |
| Apr 7, 2021 | Roche Diagnostics Operations, Inc. Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. Open, Classified |
MMI | K082699 |
| Apr 7, 2021 | Roche Diagnostics Operations, Inc. Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. Open, Classified |
MMI | K082699 |
| Feb 8, 2021 | Roche Diagnostics Operations, Inc. 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate sol Terminated |
JFP | K961458 |
| Jan 7, 2021 | Roche Diagnostics Operations, Inc. CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin.
Catalog 04837738001 Terminated |
GJS | K062925 |
| Jan 7, 2021 | Roche Diagnostics Operations, Inc. CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
Catalog: 04837975001
Units could cons Terminated |
GJS | K060978 |
| Dec 17, 2020 | Roche Diagnostics Operations, Inc. A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data
Catalog Number: 07154003001 Terminated |
JQP | None listed |
| Dec 8, 2020 | Roche Diagnostics Operations, Inc. Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use
Part Number: 05641446001 Open, Classified |
JJE | K191899 |
| Dec 8, 2020 | Roche Diagnostics Operations, Inc. Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use
Open, Classified |
JJE | K100853 |
| Nov 23, 2020 | Roche Diagnostics Operations, Inc. cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use Terminated |
JJE | K191899 |
| Nov 6, 2020 | Roche Diagnostics Operations, Inc. Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzer Terminated |
DCN | K083444 |
| Oct 9, 2020 | Roche Diagnostics Operations, Inc. cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software Terminated |
JQP | None listed |
| Aug 31, 2020 | Roche Diagnostics Operations, Inc. DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only)
Material Number: 05987750001 Open, Classified |
KPA | None listed |
| Aug 31, 2020 | Roche Diagnostics Operations, Inc. BenchMark ULTRA Advanced Staining System (IVD)-
Material Number: 05342716001 Open, Classified |
KPA | None listed |
| Aug 27, 2020 | Roche Diagnostics Operations, Inc. Albumin Gen.2, Catalog 05166861190 Terminated |
CIX | K033009 |
| Aug 27, 2020 | Roche Diagnostics Operations, Inc. Tina-quant Complement C4 ver.2, Catalog 05991994190 Terminated |
DBI | K012359 |
| Aug 20, 2020 | Roche Diagnostics Operations, Inc. Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190 Terminated |
JZO | K051890 |
| Mar 5, 2020 | Roche Diagnostics Operations, Inc. Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer Terminated |
NIG | K050231 |
| Jan 7, 2020 | Roche Diagnostics Operations, Inc. cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use. Terminated |
JQP | None listed |
| Oct 28, 2019 | Roche Diagnostics Operations, Inc. Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma
Catalog number: 07026773190 Terminated |
LOL | K093955 |
| Oct 16, 2019 | Roche Diagnostics Operations, Inc. Cobas c Bilirubin Total Gen.3
Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/H Terminated |
CIG | K131544 |
| Oct 16, 2019 | Roche Diagnostics Operations, Inc. Roche Diagnostics cobas Integra Albumin Gen.2
Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi co Terminated |
CIX | K033009 |
| Oct 8, 2019 | Roche Diagnostics Operations, Inc. Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use
Material Number: 07154003001 Terminated |
JQP | None listed |
| Oct 4, 2019 | Roche Diagnostics Operations, Inc. Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems
Catalog Number: 06542921190 - - Product Usage: Terminated |
LPS | K113793 |
| Aug 28, 2019 | Roche Diagnostics Operations, Inc. cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay
Catalog Number: 05950821190 Terminated |
DDG | K003064 |
| Aug 28, 2019 | Roche Diagnostics Operations, Inc. cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay
Catalog Number: 20763454122 Terminated |
DDG | K003064 |
| Aug 23, 2019 | Roche Diagnostics Operations, Inc. Roche Elecsys Anti-CCP Immunoassay
Catalog # 05031656160 Terminated |
NHX | K081338 |
| Aug 23, 2019 | Roche Diagnostics Operations, Inc. Roche Elecsys Anti-CCP Immunoassay
Catalog # 07251670190 Terminated |
NHX | K081338 |
| Aug 13, 2019 | Roche Diagnostics Operations, Inc. AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids)
Catalog Number: 5694 Terminated |
JLW | K162606 |
| Jul 23, 2019 | Roche Diagnostics Operations, Inc. Online TDM Vancomycin Gen.3 ( 200 tests)
Catalog # 06779344190
Analyzer/Module: cobas c 311 and cobas c 501/502 Terminated |
LEH | K152245 |
| Jul 23, 2019 | Roche Diagnostics Operations, Inc. Online TDM Vancomycin Gen.3 (100 tests)
Catalog # 06779336190
Analyzer/Module: cobas c 311 and cobas c 501/502 Terminated |
LEH | K152245 |
| Jul 18, 2019 | Roche Diagnostics Operations, Inc. cobas c513 Analyzer Terminated |
JJE | K160571 |
| Jul 18, 2019 | Roche Diagnostics Operations, Inc. Cobas 8000 Modular Analyzer Series:
cobas 8000 ISE module part Numbers : 05964075001
cobas c 701 module part Numbers : 05641489001
cobas c 702 module part Numbers : 06473245001 Terminated |
JJE | K100853 |
| Jul 18, 2019 | Roche Diagnostics Operations, Inc. cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001 Terminated |
JJE | K060373 |
| Jul 2, 2019 | Roche Diagnostics Operations, Inc. The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry a Terminated |
DDR | K061683 |
| Jan 24, 2017 | Roche Diagnostics Operations, Inc. Tina-Quant (Latex) HS Test System
(C-Reactive Protein (Latex) High Sensitive)
The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-re Terminated |
NQD | K042485 |
| Jan 23, 2017 | Roche Diagnostics Operations, Inc. Cobas b 123 POC system
The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), m Terminated |
CHL | K111188 |
| Nov 11, 2016 | Roche Diagnostics Operations, Inc. COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test
Catalog number 04528123160 Terminated |
PDJ | None listed |
| Nov 11, 2016 | Roche Diagnostics Operations, Inc. Tina-Quant Hemoglobin A1c Gen. 2
Hemoglobin A1c test
Catalog number 04528123190 / 05401640190 Terminated |
LCP | K072714 |
| Nov 10, 2016 | Roche Diagnostics Operations, Inc. Roche COBAS INTEGRA c111
Analyzer, Chemistry (Photometric, Discrete), for clinical use
Product Usage:
The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing cl Terminated |
JJE | K071211 |
| Oct 31, 2016 | Roche Diagnostics Operations, Inc. MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the
Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system
The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to Terminated |
CDS | K032311 |
Newest 50 of 151.