# K032804: Cryocheck Weak Lupus Positive Control

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic
- Decided: Nov 3, 2003 after 55 days
- Product code: GGC (Control, Plasma, Abnormal)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952623 (1995). 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)
- K952623: Cryo Check Lupus Plasma, Precision Biologicals, Inc. (1995) Summary page 1.

## Indications for use
CryoCheck Weak Lupus Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.

Source page: https://510kreport.com/device/K032804
Methodology: https://510kreport.com/methodology