DER · Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5580 · Class 2
Overview
| Product Code | DER |
|---|---|
| Device Name | Alpha-1-Lipoprotein, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5580 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An alpha-1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K013249 | TINA-QUANT APOLIPOPROTEIN VER.2 | Roche Diagnostics Corp. | Nov 16, 2001 | SESE |
| K000921 | BAYER ADVIA IMS SYSTEM; 200 + 3 | Bayer Corp. | May 18, 2000 | SESE |
| K993354 | K-ASSAY APO B | Kamiya Biomedical Co. | Oct 28, 1999 | SESE |
| K993345 | K-ASSAY APO AI | Kamiya Biomedical Co. | Oct 25, 1999 | SESE |
| K990594 | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 | Roche Diagnostics Corp. | Apr 14, 1999 | SESE |
| K983289 | APOLIPOPROTEIN A1 | Abbott Laboratories | Jan 29, 1999 | SESE |
| K964296 | N-ASSAY TIA APO B TEST KIT | Crestat Diagnostics, Inc. | Aug 1, 1997 | SESE |
| K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | Crestat Diagnostics, Inc. | Aug 1, 1997 | SESE |
| K964292 | N-ASSAY TIA APO A1 TEST KIT | Crestat Diagnostics, Inc. | Aug 1, 1997 | SESE |
| K910553 | ROCHE APOLIPOPROTEIN STANDARD | Roche Diagnostic Systems, Inc. | May 8, 1991 | SESE |
| K904125 | UC IMU A | Eucardio Laboratory, Inc. | Sep 24, 1990 | SESE |
| K872078 | QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL | Solomon Park Research Laboratories | Jun 18, 1987 | SESE |
| K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | Photec Diagnostics, Inc. | Jan 24, 1986 | SESE |
| K853048 | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | Photec Diagnostics, Inc. | Aug 28, 1985 | SESE |
| K851649 | APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 | Photec Diagnostics, Inc. | Jun 5, 1985 | SESE |
| K840830 | VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN | Ventrex Laboratories, Inc. | May 21, 1984 | SESE |
| K802610 | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT | Hyland Therapeutic Div., Travenol Laboratories | Jan 5, 1981 | SESE |
Top Applicants
- Crestat Diagnostics, Inc. — 3 clearances
- Photec Diagnostics, Inc. — 3 clearances
- Kamiya Biomedical Co. — 2 clearances
- Roche Diagnostics Corp. — 2 clearances
- Abbott Laboratories — 1 clearance
