| CLSI C59-A Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 7-175 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Paula Caposino FDA/OMPT/CDRH/OIR/DCTD/CRDB/ 301-796-6160 paula.caposino@fda.hhs.gov |
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This guideline describes the characterization and preparation of immunogens, antibodies, samples, and methods, and provides guidance for immunochemical testing of apolipoproteins.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.5600 | Lipoprotein, Low-Density, Antigen, Antiserum, Control | Class 2 | DFC |
| §866.5580 | Alpha-1-Lipoprotein, Antigen, Antiserum, Control | Class 2 | DER |
| §862.1475 | Apolipoproteins | Class 1 | MSJ |
| There is no relevant guidance developed at this time. |