# K012768: Hemosil Recombi Plastin

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 18, 2001 after 32 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 K862301 (1986). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925604: Ortho (TM) Recombiplastin W/Ortho Diluent, Ortho Diagnostic Systems, Inc. (1993) Summary page 1.
- K862301: IL System 810, Acl and the Reagent Sets, Instrumentation Laboratory CO (1986) Summary page 1.

## Most influential descendants
- K043184: Hemosil Recombiplastin (2004), 3 descendants of its own
- K070005: Hemosil Recombiplastin 2G (2007), 2 descendants of its own
- K122584: Hemosil Readiplas Tin (2013), 1 descendant of its own
- K213426: HemosIL ReadiPlasTin (2022), 0 descendants of its own

## 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 - 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/K012768
Methodology: https://510kreport.com/methodology