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
191d
Avg (2y)
1976
Since
11190 Chemistry devices
1426–1450 of 11190
Cleared Oct 14, 2011
RANDOX DIGOXIN ASSAY
K102346 · Randox Laboratories, Ltd.
KXT · Enzyme Immunoassay, Digoxin · 421d
Cleared Oct 07, 2011
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
K110780 · Elitechgroup
CIG · Diazo Colorimetry, Bilirubin · 200d
Cleared Oct 06, 2011
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
K111371 · ACON Laboratories, Inc.
CGA · Glucose Oxidase, Glucose · 143d
Cleared Oct 06, 2011
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
K110579 · Abbott Laboratories
CDD · Radioassay, Vitamin B12 · 219d
Cleared Oct 04, 2011
TECO DIAGNOSTICS SALIVA ALCOHOL TEST
K111206 · Teco Diagnostics
DIC · Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method · 158d
Cleared Oct 04, 2011
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · Taidoc Technology Corporation
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 312d
Cleared Sep 30, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
K112738 · Andon Medical Co., Ltd.
NBW · System, Test, Blood Glucose, Over The Counter · 10d
Cleared Sep 30, 2011
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
K110904 · Randox Laboratories, Ltd.
JJY · Multi-analyte Controls, All Kinds (assayed) · 183d
Cleared Sep 30, 2011
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
K110846 · Randox Laboratories Limited
JJW · Urinalysis Controls (assayed And Unassayed) · 186d
Cleared Sep 27, 2011
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
K111516 · Liposcience, Inc.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 118d
Cleared Sep 27, 2011
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
K103396 · I-Sens, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 312d
Cleared Sep 23, 2011
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
K112071 · Guangzhou Wondfo Biotech Co., Ltd.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 65d
Cleared Sep 21, 2011
EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
K110435 · U. S. Diagnostics, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 218d
Cleared Sep 21, 2011
CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
K110061 · Siemens Healthcare Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 254d
Cleared Sep 21, 2011
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K101299 · Roche Diagnostics
LFR · Glucose Dehydrogenase, Glucose · 499d
Cleared Sep 19, 2011
GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE
K112356 · Bionostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 34d
Cleared Sep 19, 2011
WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
K112236 · Guangzhou Wondfo Biotech Co., Ltd.
LAF · Gas Chromatography, Methamphetamine · 46d
Cleared Sep 16, 2011
EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K111728 · Eps Bio Technology Corp.
CGA · Glucose Oxidase, Glucose · 88d
Cleared Sep 15, 2011
GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
K102816 · Apex BioTechnology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 352d
Cleared Sep 14, 2011
ELECSYS MYOGLOBIN CALCHECK 5
K112113 · Roche Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 51d
Cleared Sep 14, 2011
ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
K111996 · Elitechgroup
JJY · Multi-analyte Controls, All Kinds (assayed) · 63d
Cleared Sep 08, 2011
POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
K110818 · Polymedco, Inc.
CIX · Bromcresol Green Dye-binding, Albumin · 168d
Cleared Sep 08, 2011
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
K103615 · Alfa Wassermann Diagnostic Technologies, Inc.
CDN · Urease, Photometric, Urea Nitrogen · 273d
Cleared Sep 07, 2011
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K112272 · Eps Bio Technology Corp.
LFR · Glucose Dehydrogenase, Glucose · 30d
Cleared Sep 07, 2011
ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
K110637 · Cilag GmbH International
LFR · Glucose Dehydrogenase, Glucose · 187d

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All categories 11190 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 457 JJX Single (specified) Analyte Controls (assayed And Unassayed) 382 CGA Glucose Oxidase, Glucose 298 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 247 CIG Diazo Colorimetry, Bilirubin 216 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 175 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 156 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143