# K242127: ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory (IL) Co.
- Decided: Aug 16, 2024 after 28 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002400 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Instrumentation Laboratory CO (2015) Summary page 4.

## Indications for use
The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) are bench top, fully automated, random access 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/K242127
Methodology: https://510kreport.com/methodology