# K981479: IL Test PT-Fibrinogen Recombinant

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Jul 7, 1998 after 74 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- 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 K933252 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933252: IL Test (TM) PT-Fibrinogen HS Plus, Instrumentation Laboratory CO (1993) Summary page 1.

## Most influential descendants
- K020840: Vital Scientific PT with Calcium (2002), 0 descendants of its own

## Indications for use
IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma using a high sensitivity recombinant rabbit tissue factor based thromboplastin. This product is intended for the evaluation of the extrinsic coagulation pathway, monitoring Oral Anticoagulant Therapy (OAT) and for quantitation of fibrinogen.

Source page: https://510kreport.com/device/K981479
Methodology: https://510kreport.com/methodology