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
11204 Chemistry devices
2176–2200 of 11204
Cleared Jul 21, 2006
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
K061588 · Ortho-Clinical Diagnostics, Inc.
LPS · Urinary Homocystine (nonquantitative) Test System · 43d
Cleared Jul 21, 2006
QMS TOBRAMYCIN
K060998 · Seradyn, Inc.
LCR · Fluorescent Immunoassay, Tobramycin · 101d
Cleared Jul 21, 2006
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
K060619 · Diazyme Laboratories
KHS · Enzymatic, Carbon-dioxide · 135d
Cleared Jul 21, 2006
GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060205 · Horiba Abx
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 176d
Cleared Jul 21, 2006
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
K053597 · I-Stat Corporation
NBC · Test, Natriuretic Peptide · 210d
Cleared Jul 18, 2006
DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
K061818 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 20d
Cleared Jul 18, 2006
DAVID PREGNANCY TEST (MIDSTREAM)
K053236 · Runbio Biotech Co.,Ltd
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 242d
Cleared Jul 13, 2006
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
K061751 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 22d
Cleared Jul 13, 2006
PRODIGY BLOOD GLUCOSE TEST SYSTEM
K060467 · Diagnostic Devices, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 140d
Cleared Jul 10, 2006
DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)
K061702 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 24d
Cleared Jul 10, 2006
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · Dade Behring, Inc.
LDP · Colorimetry, Acetaminophen · 27d
Cleared Jul 10, 2006
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
K060788 · Biosite Incorporated
DIF · Drug Mixture Control Materials · 109d
Cleared Jul 06, 2006
ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
K061181 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 70d
Cleared Jul 06, 2006
PRODIGY
K053593 · Diagnostic Devices, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 195d
Cleared Jul 05, 2006
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
K061390 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 48d
Cleared Jul 03, 2006
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769 · Unipath , Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 10d
Cleared Jul 03, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
K060480 · Ortho-Clinical Diagnostics
CGR · Radioimmunoassay, Cortisol · 130d
Cleared Jun 30, 2006
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
K061218 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 60d
Cleared Jun 23, 2006
CREATININE
K061193 · Abbott Laboratories, Inc.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 56d
Cleared Jun 19, 2006
MULTI-USE ELECTRONIC PREGNANCY TEST
K060825 · Mizuho USA, Inc.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 84d
Cleared Jun 19, 2006
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
K060510 · Drew Scientific , Ltd.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 112d
Cleared Jun 16, 2006
EZ SMART-168 GLUCOSE MONITORING SYSTEM
K052818 · Tyson Bioresearch, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 255d
Cleared Jun 15, 2006
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541
K061464 · Ortho-Clinical Diagnostics, Inc.
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 21d
Cleared Jun 15, 2006
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
K060364 · Teco Diagnostics
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 122d
Cleared Jun 14, 2006
ABBOTT AXSYM TROPONIN-I ADV
K060875 · Abbott Laboratories
MMI · Immunoassay Method, Troponin Subunit · 76d

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All categories 11204 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 175 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