# K983281: APOB

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jan 26, 1999 after 130 days
- Product code: DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5600
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964296 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964296: N-Assay Tia Apo B Test Kit, Crestat Diagnostics, Inc. (1997) Summary page 2.

## Recalls of this device
- May 16, 2018 · Class II · Z-1994-2019: 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.

## Indications for use
The Apolipoprotein B assay is used for the quantitation of apolipoprotein B in human serum or plasma. Apolipoprotein B meaurements are useful in the diagnosis of premature coronary artery disease, hyper-b-lipoproteinemia, and hypo-b-lipoproteinemia.

Source page: https://510kreport.com/device/K983281
Methodology: https://510kreport.com/methodology