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.

13237
Total
13205
Cleared
181d
Avg (2y)
1976
Since
11215 Chemistry devices
2951–2975 of 11215
Cleared Jul 17, 2002
ALBUMIN REAGENT
K021636 · Intersect Systems, Inc.
CJW · Bromcresol Purple Dye-binding, Albumin · 61d
Cleared Jul 17, 2002
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
K021526 · ACON Laboratories, Inc.
LFG · Radioimmunoassay, Tricyclic Antidepressant Drugs · 68d
Cleared Jul 16, 2002
EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
K021515 · Medica Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 67d
Cleared Jul 13, 2002
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K021151 · Bayer Diagnostics Corp.
JIF · Enzymatic Method, Ammonia · 94d
Cleared Jul 12, 2002
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
K022053 · Sebia
JHO · Electrophoretic Separation, Lipoproteins · 18d
Cleared Jul 12, 2002
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
K021697 · Bionostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 51d
Cleared Jul 12, 2002
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
K021624 · Bionostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 57d
Cleared Jul 05, 2002
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428 · Bayer Corp.
JFY · Enzymatic Method, Creatinine · 63d
Cleared Jul 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021827 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 29d
Cleared Jul 03, 2002
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA
K021332 · Wiener Laboratories Saic
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 68d
Cleared Jul 03, 2002
POLY-CHEM GLUCOSE
K020852 · Polymedco, Inc.
CFR · Hexokinase, Glucose · 110d
Cleared Jul 03, 2002
CARESIDE LDH
K020484 · Careside, Inc.
CFH · Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase · 140d
Cleared Jul 01, 2002
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K021317 · Biosite Incorporated
NBC · Test, Natriuretic Peptide · 67d
Cleared Jul 01, 2002
CARESIDE GGT
K020486 · Careside, Inc.
JPZ · Colorimetric Method, Gamma-glutamyl Transpeptidase · 138d
Cleared Jun 28, 2002
ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
K021943 · Lifescan, Inc.
CGA · Glucose Oxidase, Glucose · 31d
Cleared Jun 28, 2002
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
K021229 · Beckman Coulter, Inc.
DDR · Myoglobin, Antigen, Antiserum, Control · 71d
Cleared Jun 27, 2002
RDI HS CRP KIT
K021609 · Reference Diagnostics, Inc.
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 42d
Cleared Jun 27, 2002
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
K021535 · Bayer Diagnostics Corp.
JIT · Calibrator, Secondary · 48d
Cleared Jun 27, 2002
ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR
K021532 · Bayer Diagnostics Corp.
JIT · Calibrator, Secondary · 48d
Cleared Jun 25, 2002
MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL
K021930 · Bionostics, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 13d
Cleared Jun 21, 2002
QUPID PLUS E.R.
K020378 · Stanbio Laboratory
JHI · Visual, Pregnancy Hcg, Prescription Use · 136d
Cleared Jun 11, 2002
ACCU-CHEK ADVANTAGE MODULE
K021513 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 33d
Cleared Jun 11, 2002
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
K020866 · Abbott Diabetes Care, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 85d
Cleared Jun 10, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K020297 · Nova Biomedical Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 133d
Cleared Jun 04, 2002
CARESIDE ALT
K020487 · Careside, Inc.
CKA · Nadh Oxidation/nad Reduction, Alt/sgpt · 111d

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All categories 11215 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 461 JJX Single (specified) Analyte Controls (assayed And Unassayed) 384 CGA Glucose Oxidase, Glucose 299 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 248 CIG Diazo Colorimetry, Bilirubin 217 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 176 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 157 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143