# K061377: Apolipoprotein A1 and Apolipoprotein B Reagents and Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Mar 28, 2007 after 315 days
- Product code: MSJ (Apolipoproteins)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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
These products are to be used for the quantitative determination of apolipoprotein Al and apolipoprotein B in human serum by immunoturbidimetric analysis. The determination of apolipoprotein Al and apolipoprotein B are commonly performed as an aid in the assessment of individuals who are at risk for developing coronary artery disease.

Source page: https://510kreport.com/device/K061377
Methodology: https://510kreport.com/methodology