# K983289: Apolipoprotein A1

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jan 29, 1999 after 133 days
- Product code: DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5580
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964292 (1997). 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)
- K964292: N-Assay Tia Apo A1 Test Kit, Crestat Diagnostics, Inc. (1997) Summary page 2.

## Most influential descendants
- K123372: Abbott Lipid Multi Constituent Calibrator (2013), 0 descendants of its own

## Recalls of this device
- May 16, 2018 · Class II · Z-1991-2019: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
- Nov 10, 2005 · Not classified · Z-0383-06: These specific protein assays are not meeting the 57-day on board stability claim

## Indications for use
The Apolipoprotein Al assay is used for the quantitation of apolipoprotein Al in human serum or plasma. Measurement of A lipoproteins, the major proteins found in HDL (high density lipoprotein), is used in the diagnosis and treatment of premature coronary artery disease, hyper-a-lipoproteinemia, and hypo-a-lipoproteinemia.

Source page: https://510kreport.com/device/K983289
Methodology: https://510kreport.com/methodology