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.
13234
Total
13203
Cleared
199d
Avg (2y)
1976
Since
8200 Chemistry devices
Cleared
Apr 02, 2015
Total Bilirubin
CIG
Diazo Colorimetry, Bilirubin
34d
Cleared
Mar 31, 2015
ADVIA Centaur Cortisol (COR) Assy
JFT
Fluorometric, Cortisol
189d
Cleared
Mar 24, 2015
VARIANT II TURBO HbA1c Kit - 2.0
PDJ
Hemoglobin A1c Test System
203d
Cleared
Mar 13, 2015
Liquichek Maternal Serum II Control
JJY
Multi-analyte Controls, All Kinds (assayed)
108d
Cleared
Mar 03, 2015
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
236d
Cleared
Feb 26, 2015
IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
93d
Cleared
Feb 26, 2015
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
JIT
Calibrator, Secondary
133d
Cleared
Feb 25, 2015
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
65d
Cleared
Jan 23, 2015
Audit MicroControls Linearity LQ Cystatin-C
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
37d
Cleared
Jan 14, 2015
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
35d
Cleared
Jan 13, 2015
CR3 Keyless Split Sample Cup Secobarbital- Methadone
DIS
Enzyme Immunoassay, Barbiturate
29d
Cleared
Jan 09, 2015
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D
MRG
System, Test, Vitamin D
254d
Cleared
Dec 23, 2014
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
OSX
Galectin-3 In Vitro Diagnostic Assay
305d
Cleared
Dec 22, 2014
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
JFY
Enzymatic Method, Creatinine
117d
Cleared
Dec 22, 2014
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst
MRG
System, Test, Vitamin D
119d
Cleared
Dec 19, 2014
Elecsys T-Uptake Calset
JIT
Calibrator, Secondary
28d
Cleared
Dec 19, 2014
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
MRG
System, Test, Vitamin D
116d
Cleared
Dec 16, 2014
Elecsys Estradiol III Calcheck
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
29d
Cleared
Dec 10, 2014
LIASON XL1,25 DIHYDROXYVITAMIN D
MRG
System, Test, Vitamin D
190d
Cleared
Dec 05, 2014
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
29d
Cleared
Nov 26, 2014
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
CEC
Radioimmunoassay, Free Thyroxine
237d
Cleared
Nov 26, 2014
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
CEC
Radioimmunoassay, Free Thyroxine
238d
Cleared
Nov 21, 2014
Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
31d
Cleared
Nov 20, 2014
Audit MicroControls Linearity LQ Special Diabetes
JJY
Multi-analyte Controls, All Kinds (assayed)
36d
Cleared
Nov 17, 2014
CLINITEK NOVUS
KQO
Automated Urinalysis System
242d
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