Alpha-1-Lipoprotein, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting alpha-1-lipoprotein (high-density lipoprotein, HDL), the plasma lipoprotein involved in reverse cholesterol transport, including antigen, antiserum, and control components for immunoassay-based measurement in clinical laboratories. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification, and is eligible for third-party review. The product code is DER, regulated under 21 CFR 866.5580, within the Immunology specialty.
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Basic Information
- Product Code
- DER
- Device Class
- FDA class 2
- Regulation Number
- 866.5580
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K013249 | TINA-QUANT APOLIPOPROTEIN VER.2 | Nov 16, 2001 | Substantially Equivalent | Roche Diagnostics Corp. |
| K000921 | BAYER ADVIA IMS SYSTEM; 200 + 3 | May 18, 2000 | Substantially Equivalent | Bayer Corp. |
| K993354 | K-ASSAY APO B | Oct 28, 1999 | Substantially Equivalent | Kamiya Biomedical Co. |
| K993345 | K-ASSAY APO AI | Oct 25, 1999 | Substantially Equivalent | Kamiya Biomedical Co. |
| K990594 | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 | Apr 14, 1999 | Substantially Equivalent | Roche Diagnostics Corp. |
| K983289 | APOLIPOPROTEIN A1 | Jan 29, 1999 | Substantially Equivalent | Abbott Laboratories |
| K964296 | N-ASSAY TIA APO B TEST KIT | Aug 01, 1997 | Substantially Equivalent | Crestat Diagnostics, Inc. |
| K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | Aug 01, 1997 | Substantially Equivalent | Crestat Diagnostics, Inc. |
| K964292 | N-ASSAY TIA APO A1 TEST KIT | Aug 01, 1997 | Substantially Equivalent | Crestat Diagnostics, Inc. |
| K910553 | ROCHE APOLIPOPROTEIN STANDARD | May 08, 1991 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K904125 | UC IMU A | Sep 24, 1990 | Substantially Equivalent | Eucardio Laboratory, Inc. |
| K872078 | QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL | Jun 18, 1987 | Substantially Equivalent | Solomon Park Research Laboratories |
| K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | Jan 24, 1986 | Substantially Equivalent | Photec Diagnostics, Inc. |
| K853048 | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | Aug 28, 1985 | Substantially Equivalent | Photec Diagnostics, Inc. |
| K851649 | APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 | Jun 05, 1985 | Substantially Equivalent | Photec Diagnostics, Inc. |
| K840830 | VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN | May 21, 1984 | Substantially Equivalent | Ventrex Laboratories, Inc. |
| K802610 | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT | Jan 05, 1981 | Substantially Equivalent | Hyland Therapeutic Div., Travenol Laboratories |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.