FDA Review Panel · CH

FDA 510(k) Chemistry Devices

FDA 510(k) Chemistry Devices - Regulatory Overview

FDA 510(k) chemistry devices cover in vitro diagnostic (IVD) instruments used in clinical laboratories. The FDA review panel code is CH.

This category includes:

  • Clinical chemistry analyzers - glucose, electrolytes, enzymes, proteins
  • Point-of-care test systems - rapid diagnostics for hospital and home use
  • Reagents and calibrators - consumables used with automated analyzers
  • Urinalysis systems - dipstick readers and urine sediment analyzers

Most devices in this panel are Class II (Special Controls) under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.

13224
Total
13193
Cleared
208d
Avg (2y)
1976
Since
3201 Chemistry devices
601–625 of 3201
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
K160225 · Instrumentation Laboratory CO
JGS · Electrode, Ion Specific, Sodium · 320d
Cleared Sep 14, 2016
GEM Premier 3000
K161818 · Instrumentation Laboratory CO
CGA · Glucose Oxidase, Glucose · 75d
Cleared Aug 18, 2016
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
K153651 · Beckman Coulter, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 241d
Cleared Aug 12, 2016
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
K153375 · Abbott Laboratories
MRG · System, Test, Vitamin D · 263d
Cleared Dec 17, 2015
Freestyle Freedom Blood Glucose Monitoring Sytem
K152442 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 112d
Cleared Dec 17, 2015
ARCHITECT 2nd Generation Testosterone
K152155 · Abbott Laboratories
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 136d
Cleared Jul 10, 2015
Abbott ARCHITECT Total T4 Calibrators
K151566 · Abbott Laboratories
JIT · Calibrator, Secondary · 30d
Cleared Jun 05, 2015
FreeStyle Freedom Lite Blood Glucose Monitoring System
K150531 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 95d
Cleared Jun 05, 2015
FreeStyle Lite Blood Glucose Monitoring System
K150332 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 115d
Cleared May 22, 2015
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
K140654 · Abbott Laboratories
PDJ · Hemoglobin A1c Test System · 434d
Cleared Apr 02, 2015
Total Bilirubin
K150510 · Abbott Laboratories
CIG · Diazo Colorimetry, Bilirubin · 34d
Cleared Feb 26, 2015
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
K142985 · Beckman Coulter, Inc.
JIT · Calibrator, Secondary · 133d
Cleared Dec 22, 2014
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst
K142373 · Beckman Coulter, Inc.
MRG · System, Test, Vitamin D · 119d
Cleared Dec 19, 2014
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
K142362 · Beckman Coulter, Inc.
MRG · System, Test, Vitamin D · 116d
Cleared Sep 16, 2014
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
K140496 · Beckman Coulter, Inc.
CDD · Radioassay, Vitamin B12 · 201d
Cleared Jul 14, 2014
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
K140829 · Beckman Coulter, Inc.
LCP · Assay, Glycosylated Hemoglobin · 104d
Cleared Apr 17, 2014
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
K131189 · Beckman Coulter, Inc.
CFR · Hexokinase, Glucose · 356d
Cleared Feb 28, 2014
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
K130255 · Abbott Laboratories
PDJ · Hemoglobin A1c Test System · 392d
Cleared Jan 13, 2014
GEM PREMIER 4000
K133407 · Instrumentation Laboratory CO
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 68d
Cleared Oct 01, 2013
ACCESS TOTAL BHCG (5TH IS)
K130020 · Beckman Coulter, Inc.
DHA · System, Test, Human Chorionic Gonadotropin · 271d
Cleared Sep 25, 2013
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
K121790 · Beckman Coulter, Inc.
MMI · Immunoassay Method, Troponin Subunit · 464d
Cleared Jun 14, 2013
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
K121214 · Beckman Coulter, Inc.
MMI · Immunoassay Method, Troponin Subunit · 417d
Cleared Apr 05, 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
K123089 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 186d
Cleared Mar 15, 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 56d
Cleared Feb 01, 2013
ARCHITECT TOTAL BILIRUBIN
K121985 · Abbott Laboratories
CIG · Diazo Colorimetry, Bilirubin · 210d

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All categories 3201 JJY Multi-analyte Controls, All Kinds (assayed) 124 NBW System, Test, Blood Glucose, Over The Counter 97 JJX Single (specified) Analyte Controls (assayed And Unassayed) 94 JIX Calibrator, Multi-analyte Mixture 73 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 72 CIG Diazo Colorimetry, Bilirubin 65 JIT Calibrator, Secondary 62 CGA Glucose Oxidase, Glucose 55 JLW Radioimmunoassay, Thyroid-stimulating Hormone 53 CHH Enzymatic Esterase--oxidase, Cholesterol 51 MMI Immunoassay Method, Troponin Subunit 46 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 44 JHI Visual, Pregnancy Hcg, Prescription Use 44 JIS Calibrator, Primary 41 CGX Alkaline Picrate, Colorimetry, Creatinine 38