# K060931: Hemosil PT-Fibrinogen HS Plus

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: May 2, 2006 after 27 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 1 (0 Class I)
- 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
- K183390: QNext and DG-PT (2019), 0 descendants of its own

## Recalls of this device
- Nov 21, 2014 · Class II · Z-0832-2015: Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of

## Indications for use
HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K060931
Methodology: https://510kreport.com/methodology