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
901–925 of 3201
Cleared Nov 25, 2002
ACCESS HYPERSENSITIVE HTSH ASSAY
K023093 · Beckman Coulter, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 68d
Cleared Nov 19, 2002
ELECSYS PROBNP IMMUNOASSAY
K022516 · Roche Diagnostics Corp.
NBC · Test, Natriuretic Peptide · 112d
Cleared Oct 28, 2002
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
K022941 · Abbott Laboratories
LFR · Glucose Dehydrogenase, Glucose · 55d
Cleared Oct 16, 2002
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K023065 · Dade Behring, Inc.
MKW · Cyclosporine · 30d
Cleared Oct 11, 2002
SPIFE CK KIT, MODEL 3332, 3333
K022757 · Helena Laboratories
JHY · Colorimetric Method, Cpk Or Isoenzymes · 52d
Cleared Oct 04, 2002
SYNCHRON LX I 725 CLINICAL SYSTEM
K023049 · Beckman Coulter, Inc.
JGS · Electrode, Ion Specific, Sodium · 22d
Cleared Oct 01, 2002
SPIFE LD-12 KIT, MODEL 3338
K022455 · Helena Laboratories
CFE · Electrophoretic, Lactate Dehydrogenase Isoenzymes · 67d
Cleared Sep 27, 2002
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345
K021814 · Beckman Coulter, Inc.
MMI · Immunoassay Method, Troponin Subunit · 116d
Cleared Sep 13, 2002
TOTAL BILIRUBIN
K022339 · Abbott Laboratories
CIG · Diazo Colorimetry, Bilirubin · 57d
Cleared Sep 10, 2002
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
K022158 · Instrumentation Laboratory CO
CGA · Glucose Oxidase, Glucose · 70d
Cleared Sep 09, 2002
MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM
K022182 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 68d
Cleared Sep 09, 2002
ELECSYS CORTISOL TEST SYSTEM
K021218 · Roche Diagnostics Corp.
JFT · Fluorometric, Cortisol · 145d
Cleared Sep 06, 2002
DIRECT BILIRUBIN
K022180 · Abbott Laboratories
CIG · Diazo Colorimetry, Bilirubin · 65d
Cleared Aug 29, 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
K022654 · Roche Diagnostics Corp.
JHY · Colorimetric Method, Cpk Or Isoenzymes · 20d
Cleared Aug 22, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438
K022707 · Bio-Rad
DIF · Drug Mixture Control Materials · 8d
Cleared Aug 16, 2002
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
K021960 · Abbott Laboratories
LFR · Glucose Dehydrogenase, Glucose · 63d
Cleared Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669
K022529 · Bio-Rad
JJS · Controls For Blood-gases, (assayed And Unassayed) · 15d
Cleared Aug 15, 2002
SPIFE LIPPOROTEIN-12, MODEL 3344
K022333 · Helena Laboratories
JHO · Electrophoretic Separation, Lipoproteins · 28d
Cleared Jul 23, 2002
ACCU-CHEK COMPACT SYSTEM
K022171 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 20d
Cleared Jul 22, 2002
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
K022118 · Diagnostic Products Corp.
JHX · Fluorometric Method, Cpk Or Isoenzymes · 21d
Cleared Jul 18, 2002
VIDAS TESTOSTERONE (TES), MODEL 30 418
K021326 · bioMerieux, Inc.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 83d
Cleared Jul 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021827 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 29d
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 11, 2002
ACCU-CHEK ADVANTAGE MODULE
K021513 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 33d
Cleared Jun 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021448 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 28d

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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