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.

13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
2426–2450 of 13257
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
Cleared Jan 13, 2006
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
K053247 · Maine Standards Co.
JJY · Multi-analyte Controls, All Kinds (assayed) · 53d
Cleared Jan 13, 2006
RANDOX CALIBRATION SERUM
K053153 · Randox Laboratories, Ltd.
JIX · Calibrator, Multi-analyte Mixture · 64d
Cleared Jan 13, 2006
Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
K053110 · I-Stat Corporation
JGS · Electrode, Ion Specific, Sodium · 70d
Cleared Jan 04, 2006
FASTPACK TSH IMMUNOASSAY
K052301 · Qualigen, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 135d
Cleared Dec 30, 2005
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
K053132 · Wako Chemicals USA, Inc.
JFM · Enzymatic Method, Bilirubin · 52d
Cleared Dec 30, 2005
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
K053131 · Wako Chemicals USA, Inc.
JFM · Enzymatic Method, Bilirubin · 52d
Cleared Dec 30, 2005
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
K053020 · Bayer Healthcare, LLC
MMI · Immunoassay Method, Troponin Subunit · 65d
Cleared Dec 29, 2005
FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
K052115 · First Check Diagnostics, LLC
DKZ · Enzyme Immunoassay, Amphetamine · 147d
Cleared Dec 23, 2005
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
K053109 · Dade Behring, Inc.
NQD · Cardiac C-reactive Protein, Antigen, Antiserum, And Control · 49d
Cleared Dec 23, 2005
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
K053104 · Dade Behring, Inc.
JIS · Calibrator, Primary · 49d
Cleared Dec 23, 2005
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
K052867 · Ortho-Clinical Diagnostics, Inc.
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 73d
Cleared Dec 16, 2005
ARCHITECT B12 CALIBRATORS
K053330 · Abbott Laboratories
JIT · Calibrator, Secondary · 15d

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All categories 13257 JJY Multi-analyte Controls, All Kinds (assayed) 554 NBW System, Test, Blood Glucose, Over The Counter 513 JJX Single (specified) Analyte Controls (assayed And Unassayed) 409 CGA Glucose Oxidase, Glucose 391 JHI Visual, Pregnancy Hcg, Prescription Use 359 JIX Calibrator, Multi-analyte Mixture 271 CIG Diazo Colorimetry, Bilirubin 234 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 226 JLW Radioimmunoassay, Thyroid-stimulating Hormone 226 CHH Enzymatic Esterase--oxidase, Cholesterol 226 JIT Calibrator, Secondary 224 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 223 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 199 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 183 JGS Electrode, Ion Specific, Sodium 162