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
11205 Chemistry devices
2276–2300 of 11205
Cleared Feb 27, 2006
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K060348 · Scantibodies Laboratory, Inc.
CEW · Radioimmunoassay, Parathyroid Hormone · 17d
Cleared Feb 27, 2006
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
K060256 · Beckman Coulter, Inc.
CFR · Hexokinase, Glucose · 26d
Cleared Feb 27, 2006
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
K060090 · Dade Behring, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 46d
Cleared Feb 21, 2006
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K053635 · Bionime Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 54d
Cleared Feb 17, 2006
ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)
K060019 · Artron Laboratories, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 44d
Cleared Feb 17, 2006
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
K053253 · Hemocue AB
KQO · Automated Urinalysis System · 88d
Cleared Feb 16, 2006
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
K060133 · Inverness Medical Innovations, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 29d
Cleared Feb 16, 2006
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
K060108 · Roche Diagnostics Corp.
CGZ · Electrode, Ion-specific, Chloride · 34d
Cleared Feb 16, 2006
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108
K053108 · Dade Behring, Inc.
DLJ · Calibrators, Drug Specific · 104d
Cleared Feb 15, 2006
MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
K053566 · Diazyme Laboratories
MZV · Test, System, Potassium, Enzymatic Method · 55d
Cleared Feb 09, 2006
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
K053603 · Roche Diagnostics Corp.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 48d
Cleared Feb 09, 2006
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
K052591 · Clinical Data, Inc.
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 141d
Cleared Feb 07, 2006
DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
K053576 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 47d
Cleared Feb 03, 2006
IMMULITE/IMMULITE 1000 TURBO INTACT PTH
K053533 · Diagnostic Products Corporation
CEW · Radioimmunoassay, Parathyroid Hormone · 46d
Cleared Feb 03, 2006
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
K053411 · Microgenics Corp.
LCP · Assay, Glycosylated Hemoglobin · 58d
Cleared Jan 31, 2006
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS
K051648 · Arkray, Inc.
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 224d
Cleared Jan 27, 2006
DRG SLV TESTOSTERONE ELISA TEST
K052649 · Drg Intl., Inc.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 123d
Cleared Jan 26, 2006
ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
K060027 · Biokit, S.A.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 22d
Cleared Jan 26, 2006
OXICOM CONTROL
K053327 · Bionostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 56d
Cleared Jan 26, 2006
SENTINEL PANCREATIC AMYLASE
K051447 · Sentinel Ch. Srl
JFJ · Catalytic Methods, Amylase · 238d
Cleared Jan 23, 2006
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
K052789 · Biosite Incorporated
NBC · Test, Natriuretic Peptide · 112d
Cleared Jan 23, 2006
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
K052762 · Agamatrix, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 115d
Cleared Jan 23, 2006
LIFESIGN DXPRESS, MODEL LSR2000
K050955 · Princeton BioMeditech Corp.
JHI · Visual, Pregnancy Hcg, Prescription Use · 283d
Cleared Jan 20, 2006
D-10 HEMOGLOBIN A1C PROGRAM
K060001 · Bio-Rad Laboratories, Inc.
LCP · Assay, Glycosylated Hemoglobin · 17d
Cleared Jan 17, 2006
ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
K053529 · Lifescan, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 29d

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All categories 11205 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 459 JJX Single (specified) Analyte Controls (assayed And Unassayed) 383 CGA Glucose Oxidase, Glucose 299 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 247 CIG Diazo Colorimetry, Bilirubin 217 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