# K060162: Acl Elite; Acl Elite Pro

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Feb 21, 2006 after 29 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000053 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000053: Acl 9000 System, Instrumentation Laboratory CO (2000) Summary page 1.

## Recalls of this device
- Nov 11, 2010 · Not classified · Z-0805-2011: Sporadically lowered APTT results were observed with the PT/APTT Test Groups.
- Nov 11, 2010 · Not classified · Z-0806-2011: Sporadically lowered APTT results were observed with the PT/APTT Test Groups.
- Nov 11, 2010 · Not classified · Z-0807-2011: Sporadically lowered APTT results were observed with the PT/APTT Test Groups.
- Nov 11, 2010 · Not classified · Z-0803-2011: Sporadically lowered APTT results were observed with the PT/APTT Test Groups.
- Nov 11, 2010 · Not classified · Z-0804-2011: Sporadically lowered APTT results were observed with the PT/APTT Test Groups.

## Indications for use
The ACL Elite and ACL Elite Pro are fully automated, high-productivity analyzers 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 systems provide results for both direct hemostasis measurements and calculated parameters.

Source page: https://510kreport.com/device/K060162
Methodology: https://510kreport.com/methodology