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
11217 Chemistry devices
3101–3125 of 11217
Cleared Aug 24, 2001
RANDOX HUMAN ASSSAYED DRUG CONTROL
K012319 · Randox Laboratories, Ltd.
DIF · Drug Mixture Control Materials · 32d
Cleared Aug 24, 2001
QUIK-CHECK OVULATION PREDICTOR
K012252 · ACON Laboratories, Inc.
CEP · Radioimmunoassay, Luteinizing Hormone · 37d
Cleared Aug 21, 2001
JAS URIC ACID LIQUID REAGENT
K012038 · Jas Diagnostics, Inc.
KNK · Acid, Uric, Uricase (colorimetric) · 53d
Cleared Aug 20, 2001
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
K012311 · Diagnostic Products Corp.
LCD · Enzyme Immunoassay, Gentamicin · 28d
Cleared Aug 20, 2001
VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005
K012122 · Maine Standards Co.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
K012120 · Maine Standards Co.
JJY · Multi-analyte Controls, All Kinds (assayed) · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003
K012119 · Maine Standards Co.
JJY · Multi-analyte Controls, All Kinds (assayed) · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
K012118 · Maine Standards Co.
JJY · Multi-analyte Controls, All Kinds (assayed) · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001
K012117 · Maine Standards Co.
JJY · Multi-analyte Controls, All Kinds (assayed) · 45d
Cleared Aug 20, 2001
STAT PROFILE PHOX PLUS L ANALYZER
K012058 · Nova Biomedical Corp.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 49d
Cleared Aug 10, 2001
GENZYME DIRECT-AMYLASE TEST REAGENT
K011843 · Genzyme Corp.
JFJ · Catalytic Methods, Amylase · 59d
Cleared Aug 09, 2001
MODIFICATION TO ACCU-CHEK INFORM METER
K012210 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 24d
Cleared Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · Roche Diagnostics Corp.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 19d
Cleared Aug 07, 2001
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K012287 · Roche Diagnostics Corp.
MRR · System, Test, Low Density, Lipoprotein · 18d
Cleared Aug 07, 2001
QUIK-CHECK HOME PREGNANCY TEST
K012215 · ACON Laboratories, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 22d
Cleared Aug 03, 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · Syva Co.
DKZ · Enzyme Immunoassay, Amphetamine · 16d
Cleared Jul 31, 2001
GLUCOSE (HEXOKINASE)
K011900 · Jas Diagnostics, Inc.
CFR · Hexokinase, Glucose · 43d
Cleared Jul 25, 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011692 · Intersect Systems, Inc.
LPS · Urinary Homocystine (nonquantitative) Test System · 55d
Cleared Jul 25, 2001
LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K010337 · Quantimetrix Corp.
JHO · Electrophoretic Separation, Lipoproteins · 170d
Cleared Jul 20, 2001
ALKALINE PHOSPHATASE LIQUID REAGENT
K011599 · Jas Diagnostics, Inc.
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 57d
Cleared Jul 17, 2001
CYCLOSPORINE CALIBRATOR
K011112 · Dade Behring, Inc.
DLJ · Calibrators, Drug Specific · 97d
Cleared Jul 12, 2001
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600
K011867 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 28d
Cleared Jul 09, 2001
JAS CALCIUM (ARSENAZO) REAGENT
K011441 · Jas Diagnostics, Inc.
CJY · Azo Dye, Calcium · 60d
Cleared Jul 09, 2001
TGL FLEX REAGENT CARTRIDGE
K010871 · Dade Behring, Inc.
CDT · Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · 108d
Cleared Jul 05, 2001
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
K011731 · Medical Analysis Systems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 30d

Looking for a specific chemistry device? Search by device name, K-number or manufacturer.

Search all Chemistry 510(k) devices

Filter by Product Code

All categories 11217 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 462 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 218 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