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

11214 Chemistry devices

2776–2800 of 11214

Cleared Aug 06, 2003

HEMOGLOBIN A1C REAGENT SET

K031539 · Pointe Scientific, Inc.,

LCP · Assay, Glycosylated Hemoglobin · 82d

Cleared Aug 05, 2003

TINA-QUANT CRP (LATEX)

K032336 · Roche Diagnostics Corp.

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

Cleared Aug 05, 2003

PRECISET DAT PLUS I CALIBRATORS

K031775 · Roche Diagnostics Corp.

DKB · Calibrators, Drug Mixture · 56d

Cleared Aug 05, 2003

ELECSYS SHBG IMMUNOASSAY

K031717 · Roche Diagnostics Corp.

CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 63d

Cleared Aug 05, 2003

ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS

K031472 · Lifescan, Inc.

CGA · Glucose Oxidase, Glucose · 88d

Cleared Jul 31, 2003

NICHOLS ADVANTAGE ALDOSTERONE ASSAY

K032188 · Nichols Institute Diagnostics

CJM · Radioimmunoassay, Aldosterone · 14d

Cleared Jul 30, 2003

ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC

K032089 · Roche Diagnostics Corp.

JJY · Multi-analyte Controls, All Kinds (assayed) · 23d

Cleared Jul 30, 2003

CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001

K031534 · Scantibodies Laboratory, Inc.

CEW · Radioimmunoassay, Parathyroid Hormone · 75d

Cleared Jul 17, 2003

COBAS INTEGRA CARBON DIOXIDE ASSAY

K031879 · Roche Diagnostics Corp.

KHS · Enzymatic, Carbon-dioxide · 29d

Cleared Jul 16, 2003

MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

K031890 · Medical Analysis Systems, Inc.

JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 28d

Cleared Jul 16, 2003

AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL

K031880 · Roche Diagnostics Corp.

JIX · Calibrator, Multi-analyte Mixture · 28d

Cleared Jul 11, 2003

TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS

K030703 · Home Diagnostics, Inc.

NBW · System, Test, Blood Glucose, Over The Counter · 127d

Cleared Jul 09, 2003

COBAS INTEGRA CHOLESTEROL GEN. 2

K031824 · Roche Diagnostics Corp.

CHH · Enzymatic Esterase--oxidase, Cholesterol · 26d

Cleared Jul 03, 2003

MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM

K031843 · Medline Industries, Inc.

NBW · System, Test, Blood Glucose, Over The Counter · 17d

Cleared Jul 03, 2003

ACCU-CHEK COMPACT TEST STRIP

K031755 · Roche Diagnostics Corp.

LFR · Glucose Dehydrogenase, Glucose · 27d

Cleared Jul 02, 2003

C-REACTIVE PROTEIN (CRP)

K030899 · Abbott Laboratories

DCN · System, Test, C-reactive Protein · 100d

Cleared Jul 01, 2003

URICHEMTRAK LIQUID ASSAYED URINE CONTROL

K031441 · Medical Analysis Systems, Inc.

JJW · Urinalysis Controls (assayed And Unassayed) · 56d

Cleared Jun 25, 2003

ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY

K031756 · Roche Diagnostics Corp.

CGN · Acid, Folic, Radioimmunoassay · 19d

Cleared Jun 25, 2003

LIPOPROTEIN CALIBRATOR

K031682 · Bayer Healthcare, LLC

JIX · Calibrator, Multi-analyte Mixture · 26d

Cleared Jun 25, 2003

BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL

K031644 · Bayer Healthcare, LLC

JJY · Multi-analyte Controls, All Kinds (assayed) · 29d

Cleared Jun 25, 2003

CALIBRATING MATERIAL, CALIBRATING STANDARDS

K031159 · Diamond Diagnostics, Inc.

JIT · Calibrator, Secondary · 72d

Cleared Jun 23, 2003

ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

K031038 · Bayer Healthcare, LLC

NBC · Test, Natriuretic Peptide · 83d

Cleared Jun 18, 2003

LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS

K031231 · Bio-Rad

JJW · Urinalysis Controls (assayed And Unassayed) · 61d

Cleared Jun 16, 2003

RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2

K031101 · Hemagen Diagnostics, Inc.

JJY · Multi-analyte Controls, All Kinds (assayed) · 70d

Cleared Jun 16, 2003

VIDAS TROPONIN I (TNI), MODEL 30 445

K030950 · bioMerieux, Inc.

MMI · Immunoassay Method, Troponin Subunit · 82d

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