# K063679: Acl Top

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Jan 12, 2007 after 32 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- 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). 2 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033414: Acl Top Model, Top, Instrumentation Laboratory CO (2004) Summary page 1.

## Most influential descendants
- K073377: Acl Top (with System Software V3.0.0) (2008), 11 descendants of its own
- K091980: Acl Top 700 Las (2009), 7 descendants of its own
- K150877: Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750 CTS; Acl Top 750 Las (2015), 3 descendants of its own
- K160276: Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS) (2016), 2 descendants of its own
- K083518: Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls (2009), 2 descendants of its own

## Recalls of this device
- Jun 19, 2007 · Not classified · Z-1127-2007: ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.

## Indications for use
The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurements and calculated parameters.

Source page: https://510kreport.com/device/K063679
Methodology: https://510kreport.com/methodology