# K043184: Hemosil Recombiplastin

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Dec 22, 2004 after 35 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: 2 generations back to K862301 (1986). 6 ancestors in all.
3 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)
- K012768: Hemosil Recombi Plastin, Instrumentation Laboratory CO (2001) Summary page 1.
- K951891: Acl Futura Coagulation System, Instrumentation Laboratory CO (1995) Summary page 1.
- K002400: Modification of Acl Advance, Instrumentation Laboratory CO (2000) Summary page 1.
- K033414: Acl Top Model, Top, Instrumentation Laboratory CO (2004) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Mar 7, 2006 · Not classified · Z-1246-06: Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).

## Indications for use
HemoslL RecombiPlasTin is 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/K043184
Methodology: https://510kreport.com/methodology