# K981752: I-Stat Coagulation Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Biopool Intl., Inc.
- Decided: Jun 15, 1998 after 28 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K071319: I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01, 07G82-02 (2007), 0 descendants of its own

## Indications for use
The i-STAT Activated Partial Thromboplastin (aPTT), Prothrombine Time (PT), and Activated Clotting Time (ACT) Controls are intended to be used with the i-STAT portable Clinical Analyzer and i-STAT aPTT, PT, and ACT test cartridges to provide a method for verifying the integrity of newly received cartridges. The controls produce clotting times within normal ranges and abnormal ranges to indicate that the test cartridges are functioning properly.

Source page: https://510kreport.com/device/K981752
Methodology: https://510kreport.com/methodology