Panels › Clinical Chemistry › Product code JJX · Class 1
Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation 862.1660
0510(k)s in 12 months (493 all time)
0recalls in 12 months (42 all time)
32recalls that name a 510(k)
Top companies in JJX
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostics | 60 | 0 |
| Siemens Healthcare Diagnostics | 34 | 6 |
| Boehringer Mannheim Corp. | 24 | 0 |
| Bionostics, Inc. | 22 | 0 |
| Bio-Rad | 21 | 0 |
| Ortho-Clinical Diagnostics | 13 | 3 |
| Abbott Laboratories | 4 | 9 |
| Beckman Coulter, Inc. | 9 | 4 |
| Casco Standards | 10 | 0 |
| Tosoh Medics, Inc. | 10 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT. Open, Classified |
JJX | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET. Open, Classified |
JJX | None listed |
| Jun 4, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS Open, Classified |
JJX | None listed |
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL Open, Classified |
JJX | K050328 |
| Jul 21, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the Open, Classified |
JJX | None listed |
| Feb 21, 2023 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.
Siemens Material Number (SMN): 10331250
Siem Open, Classified |
JJX | K010050 |
| Feb 21, 2023 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.
Siemens Material Number (SMN): 10325366 Open, Classified |
JJX | K010050 |
| Feb 21, 2023 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.
Siemens Material Number (SMN): 10310308 Open, Classified |
JJX | K010050 |
| Oct 15, 2021 | Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427
For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Int Terminated |
JJX | K032993 |
| Apr 30, 2021 | Sentinel CH SpA ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE)
REF 1667001 Open, Classified |
JJX | None listed |
| Jan 15, 2021 | Medline Industries Inc S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body -Hydroxybutyrate in serum or plasma. For laboratory use only. Terminated |
JJX | None listed |
| Sep 14, 2020 | Tosoh Bioscience Inc Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy
Part number: 020661
The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ON Terminated |
JJX | None listed |
| Apr 1, 2020 | Abbott Laboratories ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. Terminated |
JJX | None listed |
| May 24, 2019 | Abbott Laboratories ARCHITECT BNP Controls
Ptoduct Usage:
The ARCHITECT BNP Controls are for the estimation of test precision and the detection of
systematic analytical deviations of the ARCHITECT iSystem (reagents, ca Terminated |
JJX | K060964 |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human Terminated |
JJX | K063232 |
| Dec 3, 2018 | Randox Laboratories Ltd. Fructosamine Control 3, FR2996
This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. Open, Classified |
JJX | K023763 |
| Dec 3, 2018 | Randox Laboratories Ltd. Fructosamine Control 1, FR2994
This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. Open, Classified |
JJX | K023763 |
| Jan 10, 2017 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Systems Calibrator A Kits,
Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack)
Cat No. 04800840, SMN 10285905 (6 pack - REF) Terminated |
JJX | K961510 |
| Jan 10, 2017 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Systems Calibrator A Kits,
Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack)
Cat No. 04800840, SMN 10285905 (6 pack - REF) Terminated |
JJX | K961510 |
| Jan 10, 2017 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Systems Calibrator A Kits,
Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack)
Cat No. 04800840, SMN 10285905 (6 pack - REF) Terminated |
JJX | K961510 |
| Nov 7, 2016 | Helena Laboratories, Inc. Gel Alkaline Phosphatase Isoenzyme Control Kit:
Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE
Gel Alkaline Phosphatase Isoenzyme Control 20mL 0018 Terminated |
JJX | K895528 |
| Oct 24, 2016 | Beckman Coulter Inc. Access Ostase QC, Catalog No. 37309, B83877
Product Usage:
The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. Terminated |
JJX | K994278 |
| Nov 23, 2015 | Biochemical Diagnostics Inc CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD
Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures a Terminated |
JJX | K050328 |
| Aug 29, 2015 | Bayer Healthcare, LLC Contour Next Control Solution for Contour Next Blood Glucose Test System.
Liquid quality control solution. Plastic bottle, 2.5mL.
Indicated for use with fresh fingertip capillary whole blood samples Terminated |
JJX | K111268 |
| Jun 25, 2015 | Bio-Rad Laboratories, Inc. The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154.
The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in Terminated |
JJX | None listed |
| Oct 24, 2014 | Abbott Laboratories HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to ly Terminated |
JJX | K130255 |
| May 29, 2014 | Abbott Laboratories ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300 Terminated |
JJX | K063232 |
| Jun 21, 2013 | Microgenics Corporation Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA
MAS Bilirubin is intended for use as a cons Terminated |
JJX | K031890 |
| Apr 17, 2013 | Lifescan Inc LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902.
Testing of Blood Glucose Levels. Terminated |
JJX | K072543 |
| Apr 17, 2013 | Lifescan Inc LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603.
Testing of Blood Glucose Levels. Terminated |
JJX | K062195 |
| Mar 21, 2012 | Beckman Coulter Inc. Access Ostase QC, Part Number: 37309.
The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. Terminated |
JJX | K994277 |
| Jun 21, 2011 | Beckman Coulter Inc. Access Immunoassay Systems
Quality Control Kits, Part Number: 37309
The Access Ostase QC is used for monitoring system performance of the Access Ostase assay. Terminated |
JJX | K994277 |
| Apr 1, 2011 | Abbott Point Of Care Inc. Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02.
Used to verify the accuracy of results over the measurement range of the i-STAT cTnI test. Terminated |
JJX | K031873 |
| Apr 1, 2011 | Abbott Point Of Care Inc. Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level 2, List number 136602/06F13-02; and Cardiac Marker Control Level 3, List number 136603/06F14-02.
Used to ver Terminated |
JJX | K031873 |
| Aug 11, 2010 | Beckman Coulter Inc. Access Immunoassay Systems AFP QC, Part Number: 33219
The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprote Terminated |
JJX | K981864 |
| Nov 13, 2008 | Abbott Laboratories Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064.
A Terminated |
JJX | K984323 |
| Jul 31, 2008 | Abbott Laboratories Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C49-05
Intended for use in the verification of sensitivity, calibration linearity, and reportable r Terminated |
JJX | K984074 |
| Jul 31, 2008 | Abbott Laboratories Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C50-05.
Intended for use in the verification of sensitivity, calibration linearity, and reportable r Terminated |
JJX | K984070 |
| Jan 19, 2008 | AmniSure International LLC AmniSure ROM Test, Fetal Membrane Rupture Test for
In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138 Terminated |
JJX | K030849 |
| Oct 3, 2007 | Tosoh Bioscience Inc 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic. Terminated |
JJX | None listed |
| Sep 18, 2007 | Abbott Laboratories ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and Terminated |
JJX | K984324 |
| Mar 15, 2006 | Abbott Diabetes Care, Inc. FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502;
Part Number: CAT70676-01 Terminated |
JJX | K013147 |
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