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
651–675 of 3201
Cleared Mar 04, 2010
ELECSYS HCG STAT CALCHECK 5
K093700 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 93d
Cleared Feb 19, 2010
ACCELERATOR APS
K093318 · Abbott Laboratories
CEM · Electrode, Ion Specific, Potassium · 119d
Cleared Feb 04, 2010
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
K092649 · Roche Diagnostics Corp.
NBC · Test, Natriuretic Peptide · 160d
Cleared Feb 03, 2010
AMPHETAMINES II
K083764 · Roche Diagnostics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 412d
Cleared Dec 04, 2009
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K093458 · Beckman Coulter, Inc.
JFY · Enzymatic Method, Creatinine · 28d
Cleared Oct 16, 2009
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
K091846 · Beckman Coulter, Inc.
JFJ · Catalytic Methods, Amylase · 116d
Cleared Sep 25, 2009
ELECYS ANTI-CCP CALCHECK
K091601 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 114d
Cleared Aug 27, 2009
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
K083867 · Beckman Coulter, Inc.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 241d
Cleared Aug 14, 2009
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K091742 · Beckman Coulter, Inc.
JFY · Enzymatic Method, Creatinine · 59d
Cleared Jul 13, 2009
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
K091153 · Beckman Coulter, Inc.
KHS · Enzymatic, Carbon-dioxide · 83d
Cleared Jun 19, 2009
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
K082340 · Roche Diagnostics Corp.
CGN · Acid, Folic, Radioimmunoassay · 308d
Cleared May 27, 2009
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
K090588 · Beckman Coulter, Inc.
CDD · Radioassay, Vitamin B12 · 84d
Cleared Apr 08, 2009
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
K082251 · Beckman Coulter, Inc.
DCF · Albumin, Antigen, Antiserum, Control · 243d
Cleared Apr 07, 2009
CREATININE
K083809 · Abbott Laboratories
CGX · Alkaline Picrate, Colorimetry, Creatinine · 106d
Cleared Feb 20, 2009
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
K080481 · Beckman Coulter, Inc.
DDR · Myoglobin, Antigen, Antiserum, Control · 364d
Cleared Jun 20, 2008
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET
K080811 · Roche Diagnostics Corp.
NDY · Test, Cystatin C · 88d
Cleared May 12, 2008
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
K080607 · Roche Diagnostics Corp.
JIX · Calibrator, Multi-analyte Mixture · 69d
Cleared Apr 18, 2008
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · Roche Diagnostics Corp.
LCP · Assay, Glycosylated Hemoglobin · 206d
Cleared Mar 25, 2008
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
K080183 · Roche Diagnostics Corp.
DIF · Drug Mixture Control Materials · 60d
Cleared Mar 19, 2008
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
K080166 · Beckman Coulter, Inc.
JIT · Calibrator, Secondary · 56d
Cleared Mar 19, 2008
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525 · Abbott Laboratories
CIT · Nadh Oxidation/nad Reduction, Ast/sgot · 289d
Cleared Mar 13, 2008
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
K073604 · Dade Behring, Inc.
CEC · Radioimmunoassay, Free Thyroxine · 83d
Cleared Feb 29, 2008
VIDAS NT-PROBNP ASSAY, MODEL: 30 449
K073091 · bioMerieux, Inc.
NBC · Test, Natriuretic Peptide · 120d
Cleared Feb 27, 2008
ELECSYS PROBNP II CALCHECK
K080147 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 36d
Cleared Feb 21, 2008
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
K073072 · Dade Behring, Inc.
JHM · Colorimetric Method, Lipoproteins · 113d

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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