# K033414: Acl Top Model, Top

- Pathway: 510(k) (Abbreviated)
- Applicant: Instrumentation Laboratory CO
- Decided: Jan 12, 2004 after 77 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: 1 generation back to K002400 (2000). 1 ancestor in all.
18 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002400: Modification of Acl Advance, Instrumentation Laboratory CO (2000) Summary page 1.

## Most influential descendants
- K063679: Acl Top (2007), 12 descendants of its own
- 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
- K043184: Hemosil Recombiplastin (2004), 3 descendants of its own

## Recalls of this device
- May 19, 2005 · Not classified · Z-0915-05: Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy

## 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/K033414
Methodology: https://510kreport.com/methodology