# K070005: Hemosil Recombiplastin 2G

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Aug 15, 2007 after 224 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: 3 generations back to K862301 (1986). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043184: Hemosil Recombiplastin, Instrumentation Laboratory CO (2004) Summary page 1.

## Most influential descendants
- K122584: Hemosil Readiplas Tin (2013), 1 descendant of its own
- K213426: HemosIL ReadiPlasTin (2022), 0 descendants of its own

## Recalls of this device
- Apr 9, 2013 · Class II · Z-1784-2013: Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.

## Indications for use
A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems and Fibrinogen on IL Coagulation Systems only. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

Source page: https://510kreport.com/device/K070005
Methodology: https://510kreport.com/methodology