# K060688: Hemosil Synthasil

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Apr 13, 2006 after 29 days
- Product code: GFO (Activated Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- 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 K002400 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953981: Synthasil Aptt Reagent, Ortho Diagnostic Systems, Inc. (1995) Summary page 1.
- K033414: Acl Top Model, Top, Instrumentation Laboratory CO (2004) Summary page 1.

## Recalls of this device
- Dec 11, 2025 · Class II · Z-1095-2026: Potential for microbial contamination.

## Indications for use
HemosiL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems. The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

Source page: https://510kreport.com/device/K060688
Methodology: https://510kreport.com/methodology