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
11208 Chemistry devices
2576–2600 of 11208
Cleared Sep 03, 2004
CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR
K041627 · Dako A/S
NDY · Test, Cystatin C · 79d
Cleared Aug 30, 2004
THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
K041657 · Thermo Electron Corporation
KQN · Radioassay, Angiotensin Converting Enzyme · 73d
Cleared Aug 27, 2004
ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
K042005 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 32d
Cleared Aug 25, 2004
VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS
K041799 · Ortho-Clinical Diagnostics, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 54d
Cleared Aug 25, 2004
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II
K041720 · Ortho-Clinical Diagnostics, Inc.
MRR · System, Test, Low Density, Lipoprotein · 62d
Cleared Aug 19, 2004
TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
K042080 · Home Diagnostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 16d
Cleared Aug 19, 2004
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
K041668 · Olympus America, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 62d
Cleared Aug 18, 2004
ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR
K041687 · Abbott Laboratories
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 57d
Cleared Aug 18, 2004
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
K041643 · Beckman Coulter, Inc.
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 62d
Cleared Aug 16, 2004
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946 · ACON Laboratories, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 28d
Cleared Aug 16, 2004
CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM
K041898 · Cliniqa Corporation
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 33d
Cleared Aug 16, 2004
N LATEX CYSTATIN
K041878 · Dade Behring, Inc.
NDY · Test, Cystatin C · 35d
Cleared Aug 16, 2004
INTERLAB MICROCAL SERUM CONTROLS
K041871 · Trouble Shooter Consuling, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 38d
Cleared Aug 16, 2004
G5 I HBA1C TEST, G5 II HBA1C TEST
K041635 · Provalis Diagnostics , Ltd.
LCP · Assay, Glycosylated Hemoglobin · 61d
Cleared Aug 16, 2004
ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
K041194 · Medical Analysis Systems, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 102d
Cleared Aug 12, 2004
ARCHITECT STAT TROPONIN-I IMMUNOASSAY
K041192 · Fisher Diagnostics
MMI · Immunoassay Method, Troponin Subunit · 98d
Cleared Aug 11, 2004
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
K041728 · Immunostics Inc.,
JHI · Visual, Pregnancy Hcg, Prescription Use · 47d
Cleared Aug 09, 2004
AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
K041748 · Azog, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 41d
Not Cleared Jul 28, 2004
CEDIA SIROLIMUS ASSAY
DEN040008 · Microgenics Corp.
NRP · Sirolimus Test System · 41d
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 23, 2004
PTS PANELS CHOL+GLU TEST PANEL
K041750 · Polymer Technology Systems, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 24d
Cleared Jul 21, 2004
ARCHITECT STAT CK-MB IMMUNOASSAY
K041596 · Fisher Diagnostics
JHX · Fluorometric Method, Cpk Or Isoenzymes · 37d
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 16, 2004
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
K041793 · Olympus America, Inc.
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 14d

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All categories 11208 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 248 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