# K071319: I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01, 07G82-02

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad, Diagnostics Grp.
- Decided: Jun 26, 2007 after 47 days
- Product code: GGN (Plasma, Coagulation Control)
- 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 K981752 (1998). 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)
- K981752: I-Stat Coagulation Control Set, Biopool Intl., Inc. (1998) Summary page 1.

## Indications for use
i-STAT® Activated Clotting Time (ACT) Control is used to verify the integrity of newly received i-STAT® Activated Clotting Time cartridges.

Source page: https://510kreport.com/device/K071319
Methodology: https://510kreport.com/methodology