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

11211 Chemistry devices

2726–2750 of 11211

Cleared Nov 12, 2003

ELECSYS PROBNP IMMUNOASSAY

K032646 · Roche Diagnostics Corp.

NBC · Test, Natriuretic Peptide · 77d

Cleared Nov 07, 2003

CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE

K033061 · Diamond Diagnostics, Inc.

JIX · Calibrator, Multi-analyte Mixture · 39d

Cleared Nov 07, 2003

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

K032697 · Dade Behring, Inc.

JIS · Calibrator, Primary · 66d

Cleared Nov 05, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK

K033300 · Ortho-Clinical Diagnostics, Inc.

DDR · Myoglobin, Antigen, Antiserum, Control · 22d

Cleared Nov 03, 2003

ATAC HEMOGLOBIN A1C REAGENT KIT

K031042 · Clinical Data, Inc.

LCP · Assay, Glycosylated Hemoglobin · 216d

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 30, 2003

GLYCOHEMOSURE HBA1C CONTROL

K032791 · Quantimetrix Corp.

GGM · Control, Hemoglobin · 52d

Cleared Oct 21, 2003

LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS

K032074 · Cliniqa Corporation

JJY · Multi-analyte Controls, All Kinds (assayed) · 106d

Cleared Oct 20, 2003

EPT CERTAINTY PREGNANCY TEST

K032939 · Unipath , Ltd.

LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 28d

Cleared Oct 20, 2003

GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM

K032819 · Bionostics, Inc.

JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 40d

Cleared Oct 17, 2003

MICROGENICS CYCLOSPORINE CONTROL KIT

K032842 · Microgenics Corp.

LAS · Drug Specific Control Materials · 36d

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 14, 2003

ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)

K032661 · ACON Laboratories, Inc.

LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 47d

Cleared Oct 10, 2003

LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS

K033162 · Cliniqa Corporation

JJY · Multi-analyte Controls, All Kinds (assayed) · 10d

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 30, 2003

EXTENDED RANGE HS CRP KIT, CAT NO:9200

K030044 · Reference Diagnostics, Inc.

DCK · C-reactive Protein, Antigen, Antiserum, And Control · 267d

Cleared Sep 29, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS

K031031 · Ortho-Clinical Diagnostics, Inc.

MMI · Immunoassay Method, Troponin Subunit · 181d

Cleared Sep 22, 2003

ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST

K032510 · ACON Laboratories, Inc.

LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 39d

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