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
876–900 of 3201
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 Jul 30, 2003
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
K032089 · Roche Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 23d
Cleared Jul 17, 2003
COBAS INTEGRA CARBON DIOXIDE ASSAY
K031879 · Roche Diagnostics Corp.
KHS · Enzymatic, Carbon-dioxide · 29d
Cleared Jul 16, 2003
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
K031880 · Roche Diagnostics Corp.
JIX · Calibrator, Multi-analyte Mixture · 28d
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 Jun 25, 2003
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
K031756 · Roche Diagnostics Corp.
CGN · Acid, Folic, Radioimmunoassay · 19d
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
VIDAS TROPONIN I (TNI), MODEL 30 445
K030950 · bioMerieux, Inc.
MMI · Immunoassay Method, Troponin Subunit · 82d
Cleared Jun 02, 2003
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
K031135 · Dade Behring, Inc.
CFR · Hexokinase, Glucose · 54d
Cleared May 12, 2003
ELECSYS LH CALSET II
K031299 · Roche Diagnostics Corp.
JIT · Calibrator, Secondary · 18d
Cleared Apr 23, 2003
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO
K023256 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 205d
Cleared Jan 28, 2003
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
K023764 · Beckman Coulter, Inc.
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 77d
Cleared Jan 17, 2003
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
K030012 · Beckman Coulter, Inc.
JHX · Fluorometric Method, Cpk Or Isoenzymes · 15d
Cleared Dec 26, 2002
MODIFICATION TO ALKP
K023807 · Abbott Laboratories
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 42d
Cleared Dec 23, 2002
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
K023269 · Instrumentation Laboratory CO
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 83d
Cleared Dec 20, 2002
ACCESS TOTAL BHCG
K023480 · Beckman Coulter, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 64d
Cleared Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098 · Roche Diagnostics Corp.
JFY · Enzymatic Method, Creatinine · 7d
Cleared Dec 16, 2002
ABBOTT ARCHITECT FOLATE
K023397 · Abbott Laboratories
CGN · Acid, Folic, Radioimmunoassay · 68d
Cleared Dec 09, 2002
ACCESS TOTAL T4 ASSAY
K023369 · Beckman Coulter, Inc.
KLI · Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine · 62d
Cleared Dec 09, 2002
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
K023304 · Diagnostic Products Corp.
JKR · Radioimmunoassay, Calcitonin · 67d
Cleared Nov 29, 2002
ELECSYS PROBNP CALCHECK
K020883 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 256d

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All categories 3201 JJY Multi-analyte Controls, All Kinds (assayed) 124 NBW System, Test, Blood Glucose, Over The Counter 97 JJX Single (specified) Analyte Controls (assayed And Unassayed) 94 JIX Calibrator, Multi-analyte Mixture 73 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 72 CIG Diazo Colorimetry, Bilirubin 65 JIT Calibrator, Secondary 62 CGA Glucose Oxidase, Glucose 55 JLW Radioimmunoassay, Thyroid-stimulating Hormone 53 CHH Enzymatic Esterase--oxidase, Cholesterol 51 MMI Immunoassay Method, Troponin Subunit 46 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 44 JHI Visual, Pregnancy Hcg, Prescription Use 44 JIS Calibrator, Primary 41 CGX Alkaline Picrate, Colorimetry, Creatinine 38