# K990594: Integra Reagent Cassette for Apolipoprotein a-1

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 14, 1999 after 49 days
- Product code: DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954992 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954992: Roche Cobas Integra Reagent Cassettes, Roche Diagnostic Systems, Inc. (1996) Summary page 2.

## Most influential descendants
- K013278: Tina-Quant Apolipoprotein a-1 Ver.2 (2001), 0 descendants of its own

## Indications for use
For the quantitative determination of apolipoprotein A-1 in serum and plasma. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis,

Source page: https://510kreport.com/device/K990594
Methodology: https://510kreport.com/methodology