# K964294: N-Assay Tia Apo A1/B Multi Calibrator

- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The N-Assay TIA Apoprotein A/B Calibrator is intended to be used for the calibration of the Crestat Diagnostics N-Assay TIA Apoprotein A-1 and Apoprotein B Test Kits, which are immunoturbidimetric assays for the measurement of Apo Apoprotein A-1 and Apoprotein B in human serum.

Source page: https://510kreport.com/device/K964294
Methodology: https://510kreport.com/methodology