# 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

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Dec 13, 2015 after 256 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: 5 generations back to K002400 (2000). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073377: Acl Top (with System Software V3.0.0), Instrumentation Laboratory CO (2008) Summary page 4.
- K091980: Acl Top 700 Las, Instrumentation Laboratory CO (2009) Summary page 4.

## Most influential descendants
- 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) (2024), 0 descendants of its own
- K233790: Acl Top 970 CL (2023), 0 descendants of its own
- K231031: ACL TOP Family 70 Series (2023), 0 descendants of its own

## Recalls of this device
- Jul 13, 2023 · Class II · Z-2578-2023: Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

## 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/K150877
Methodology: https://510kreport.com/methodology