# K973306: IL Test Aptt-SP

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Nov 4, 1997 after 62 days
- Product code: GFO (Activated Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- 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 K871973 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881367: Acl Systems 100, 200, 300 and 300+ Coagulation Sys, Instrumentation Laboratory CO (1988) Summary page 1.
- K871973: IL Monarch 1000 Clinical Chemistry Analytical Sys., Instrumentation Laboratory CO (1987) Summary page 1.
- K924098: IL MCL-2 Coagulation Analyzer, Instrumentation Laboratory CO (1993) Summary page 1.
- K951891: Acl Futura Coagulation System, Instrumentation Laboratory CO (1995) Summary page 1.
- K961991: Acl 6000 System (Acl 6000), Instrumentation Laboratory CO (1996) Summary page 1.

## Indications for use
IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy.

Source page: https://510kreport.com/device/K973306
Methodology: https://510kreport.com/methodology