# K970933: Auto HDL Cholesterol Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: May 23, 1997 after 71 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the calibration of Pointe Scientific's autoHDLTM Cholesterol assay in serum or plasma. It is intended for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K970933
Methodology: https://510kreport.com/methodology