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.

13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
1451–1475 of 13257
Cleared Oct 18, 2011
ELECSYS T4 CALCHECK 5
K112528 · Roche Diagnostics Corporation
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 48d
Cleared Oct 14, 2011
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
K110586 · Siemens Healthcare Diagnostics, Inc.
MRG · System, Test, Vitamin D · 227d
Cleared Oct 14, 2011
RANDOX DIGOXIN ASSAY
K102346 · Randox Laboratories, Ltd.
KXT · Enzyme Immunoassay, Digoxin · 421d
Cleared Oct 12, 2011
PRODIGY DIABETES MANAGEMENT SOFTWARE
K103115 · Prodigy Diabetes Care, LLC
NBW · System, Test, Blood Glucose, Over The Counter · 356d
Cleared Oct 11, 2011
HEALTH-E-CONNECT SYSTEM
K102063 · Alr Technologies
NBW · System, Test, Blood Glucose, Over The Counter · 445d
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 07, 2011
DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
K102772 · Siemens Heatlhcare Diagnostics, Inc.
OAV · Mycophenolic Acid Test System · 378d
Cleared Oct 07, 2011
GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
K102316 · Broadmaster Biotech Corporation
CGA · Glucose Oxidase, Glucose · 417d
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 16, 2011
DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM
K100806 · Delbio Incorporation
NBW · System, Test, Blood Glucose, Over The Counter · 543d

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All categories 13257 JJY Multi-analyte Controls, All Kinds (assayed) 554 NBW System, Test, Blood Glucose, Over The Counter 513 JJX Single (specified) Analyte Controls (assayed And Unassayed) 409 CGA Glucose Oxidase, Glucose 391 JHI Visual, Pregnancy Hcg, Prescription Use 359 JIX Calibrator, Multi-analyte Mixture 271 CIG Diazo Colorimetry, Bilirubin 234 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 226 JLW Radioimmunoassay, Thyroid-stimulating Hormone 226 CHH Enzymatic Esterase--oxidase, Cholesterol 226 JIT Calibrator, Secondary 224 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 223 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 199 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 183 JGS Electrode, Ion Specific, Sodium 162