JFM · Enzymatic Method, Bilirubin
Clinical Chemistry · 21 CFR 862.1110 · Class 2
Overview
| Product Code | JFM |
|---|---|
| Device Name | Enzymatic Method, Bilirubin |
| Regulation | 21 CFR 862.1110 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Classification Rationale
Class II.
Cleared Devices (11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | Siemens Healthcare Diagnostics, Inc. | Mar 9, 2017 | SESE |
| K152343 | Direct Bilirubin | Randox Laboratories Limited | Feb 16, 2016 | SESE |
| K152344 | Total Bilirubin | Randox Laboratories Limited | Jan 28, 2016 | SESE |
| K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | Bayer Healthcare, LLC | Dec 7, 2007 | SESE |
| K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 | Wako Chemicals USA, Inc. | Dec 30, 2005 | SESE |
| K053131 | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 | Wako Chemicals USA, Inc. | Dec 30, 2005 | SESE |
| K053090 | DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR | Beckman Coulter, Inc. | Dec 16, 2005 | SESE |
| K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | Stanbio Laboratory | Jun 30, 2005 | SESE |
| K970985 | WAKO TOTAL BILIRUBIN V | Wako Chemicals USA, Inc. | Apr 21, 1997 | SESE |
| K904660 | ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 | Diagnostic Chemicals, Ltd. (Usa) | Nov 20, 1990 | SESE |
| K843174 | DRI-STAT ENZYMATIC BILIRUBIN TEST KIT | Beckman Instruments, Inc. | Sep 14, 1984 | SESE |
Top Applicants
- Wako Chemicals USA, Inc. — 3 clearances
- Randox Laboratories Limited — 2 clearances
- Stanbio Laboratory — 1 clearance
- Siemens Healthcare Diagnostics, Inc. — 1 clearance
- Diagnostic Chemicals, Ltd. (Usa) — 1 clearance
