# DER: Alpha-1-Lipoprotein, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5580; FDA's rule: 510(k) required
- FDA decisions: 17
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1984: 1
- 1985: 2
- 1986: 1
- 1987: 1
- 1990: 1
- 1991: 1
- 1997: 3
- 1999: 4
- 2000: 1
- 2001: 1

## Most-cited predicates
- K990594: Integra Reagent Cassette for Apolipoprotein a-1 (1999), cited by 1
- K983289: Apolipoprotein A1 (1999), cited by 1
- K964292: N-Assay Tia Apo A1 Test Kit (1997), cited by 1
- K993345: K-Assay Apo AI (1999), cited by 1
- K993354: K-Assay Apo B (1999), cited by 1
- K964296: N-Assay Tia Apo B Test Kit (1997), cited by 1

Source page: https://510kreport.com/product-code/DER
Data by year (CSV): https://510kreport.com/product-code/DER.csv