# K964292: N-Assay Tia Apo A1 Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Crestat Diagnostics, Inc.
- Decided: Aug 1, 1997 after 276 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K983289: Apolipoprotein A1 (1999), 1 descendant of its own
- K123372: Abbott Lipid Multi Constituent Calibrator (2013), 0 descendants of its own

## Indications for use
The N-Assay® TIA Apolipoprotein A-1 Test Kit is intended to be used for the quantitative determination of human apoprotein A-1 by immunoturbidimetric assay. The measurement of apoprotein A-1 is useful in the diagnosis of atherosclerosis.

Source page: https://510kreport.com/device/K964292
Methodology: https://510kreport.com/methodology