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

851–875 of 3201

Cleared Dec 19, 2003

QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2

K032663 · Instrumentation Laboratory CO

DCK · C-reactive Protein, Antigen, Antiserum, And Control · 113d

Cleared Dec 17, 2003

LIGHTCYCLER INSTRUMENT VERSION 1.2

K033734 · Roche Diagnostics Corp.

JJF · Analyzer, Chemistry, Micro, For Clinical Use · 19d

Cleared Dec 15, 2003

PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS

K033306 · Roche Diagnostics Corp.

DKB · Calibrators, Drug Mixture · 62d

Cleared Dec 12, 2003

IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER

K033234 · Diagnostic Products Corp.

DHA · System, Test, Human Chorionic Gonadotropin · 67d

Cleared Dec 05, 2003

HDL-CHOLESTEROL PLUS 2ND GENERATION

K033610 · Roche Diagnostics Corp.

LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 18d

Cleared Dec 02, 2003

QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945

K033387 · Bio-Rad

JJY · Multi-analyte Controls, All Kinds (assayed) · 40d

Cleared Nov 24, 2003

ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER

K033548 · Roche Diagnostics Corp.

KHE · Reagent, Occult Blood · 12d

Cleared Nov 20, 2003

MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)

K033501 · Roche Diagnostics Corp.

JIX · Calibrator, Multi-analyte Mixture · 15d

Cleared Nov 12, 2003

ELECSYS PROBNP IMMUNOASSAY

K032646 · Roche Diagnostics Corp.

NBC · Test, Natriuretic Peptide · 77d

Cleared Nov 07, 2003

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

K032697 · Dade Behring, Inc.

JIS · Calibrator, Primary · 66d

Cleared Oct 31, 2003

DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110

K032573 · Dade Behring, Inc.

LAR · Enzyme Immunoassay, Procainamide · 72d

Cleared Oct 31, 2003

DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111

K032564 · Dade Behring, Inc.

LAN · Enzyme Immunoassay, N-acetylprocainamide · 72d

Cleared Oct 30, 2003

DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A

K032798 · Dade Behring, Inc.

JHM · Colorimetric Method, Lipoproteins · 51d

Cleared Oct 17, 2003

ROCHE DIAGNOSTICS OMNI S ANALYZER

K032311 · Roche Diagnostics Corp.

CEM · Electrode, Ion Specific, Potassium · 81d

Cleared Oct 16, 2003

ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2

K033009 · Roche Diagnostics Corp.

CIX · Bromcresol Green Dye-binding, Albumin · 20d

Cleared Oct 14, 2003

COBAS INTEGRA ALP IFCC GEN.2

K033185 · Roche Diagnostics Corp.

CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 13d

Cleared Oct 14, 2003

PRECISET DAT AMPHETAMINE CALIBRATORS

K033165 · Roche Diagnostics Corp.

DLJ · Calibrators, Drug Specific · 14d

Cleared Oct 10, 2003

IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE

K032881 · Diagnostic Products Corp.

CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 25d

Cleared Oct 08, 2003

CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS

K032437 · Roche Diagnostics Corp.

JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 62d

Cleared Oct 06, 2003

ABBOTT ARCHITECT ESTRADIOL CALIBRATORS

K032458 · Abbott Laboratories

JIT · Calibrator, Secondary · 56d

Cleared Sep 12, 2003

ACCU-CHEK ADVANTAGE SYSTEM

K032552 · Roche Diagnostics Corp.

NBW · System, Test, Blood Glucose, Over The Counter · 24d

Cleared Aug 21, 2003

ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID

K032377 · Roche Diagnostics Corp.

KHS · Enzymatic, Carbon-dioxide · 20d

Cleared Aug 20, 2003

ELECYS SHBG CALCHECK

K031698 · Roche Diagnostics Corp.

JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 79d

Cleared Aug 18, 2003

MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

K032287 · Beckman Coulter, Inc.

JIX · Calibrator, Multi-analyte Mixture · 25d

Cleared Aug 05, 2003

TINA-QUANT CRP (LATEX)

K032336 · Roche Diagnostics Corp.

DCN · System, Test, C-reactive Protein · 7d

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