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
826–850 of 3201
Cleared Jul 27, 2004
N APOLIPOPROTEIN STANDARD SERUM
K041870 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 18d
Cleared Jul 27, 2004
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)
K041812 · Roche Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 21d
Cleared Jul 20, 2004
DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423
K041417 · Dade Behring, Inc.
NBC · Test, Natriuretic Peptide · 54d
Cleared Jul 06, 2004
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
K041561 · Bio-Rad
DIF · Drug Mixture Control Materials · 26d
Cleared Jun 07, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
K040767 · Beckman Coulter, Inc.
LBS · Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl · 74d
Cleared May 27, 2004
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
K041227 · Roche Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 17d
Cleared May 17, 2004
ELECSYS TROPONIN T STAT TEST
K040733 · Roche Diagnostics Corp.
MMI · Immunoassay Method, Troponin Subunit · 56d
Cleared May 14, 2004
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
K040174 · Roche Diagnostics Corp.
MQM · Bilirubin (total And Unbound) In The Neonate Test System · 109d
Cleared Apr 22, 2004
ACCU-CHEK GO SYSTEM
K040796 · Roche Diagnostics Corp.
LFR · Glucose Dehydrogenase, Glucose · 24d
Cleared Apr 15, 2004
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 16d
Cleared Apr 08, 2004
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
K040133 · Dade Behring, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 78d
Cleared Apr 02, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
K040264 · Roche Diagnostics Corp.
JIX · Calibrator, Multi-analyte Mixture · 58d
Cleared Mar 25, 2004
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
K040628 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 15d
Cleared Mar 24, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
K040245 · Roche Diagnostics Corp.
JIX · Calibrator, Multi-analyte Mixture · 50d
Cleared Mar 24, 2004
ACCESS DHEA-S REAGENT ASSAY
K040181 · Beckman Coulter, Inc.
JKC · Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) · 57d
Cleared Mar 11, 2004
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
K040280 · Roche Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 34d
Cleared Feb 25, 2004
ELECSYS C-PEPTIDE CALCHECK
K040157 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 33d
Cleared Jan 22, 2004
N HIGH SENSITIVITY CRP
K033908 · Dade Behring, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 36d
Cleared Jan 21, 2004
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
K034055 · Diagnostic Products Corp.
JHX · Fluorometric Method, Cpk Or Isoenzymes · 22d
Cleared Jan 12, 2004
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
K033525 · Dade Behring, Inc.
DCF · Albumin, Antigen, Antiserum, Control · 66d
Cleared Jan 12, 2004
ROCHE ONLINE TDM LIDOCAINE
K032334 · Roche Diagnostics Corp.
KLR · Enzyme Immunoassay, Lidocaine · 167d
Cleared Jan 08, 2004
PRECISION XCEED DIABETES MONITORING SYSTEM
K033845 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 28d
Cleared Jan 07, 2004
ELECSYS PRECICONTROL MULTIANALYTE
K033937 · Roche Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 19d
Cleared Dec 24, 2003
STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
K033487 · Dade Behring, Inc.
MMI · Immunoassay Method, Troponin Subunit · 50d
Cleared Dec 19, 2003
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
K033603 · Beckman Coulter, Inc.
LIG · Radioassay, Intrinsic Factor Blocking Antibody · 32d

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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