ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS— 510(k) K150877

Clearance details

Applicant

Instrumentation Laboratory CO

Product code

Code GKP

Device class

Class 2

Regulation

21 CFR 864.5400

Advisory panel

Hematology

Date received

2015-04-01

Decision date

2015-12-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bedford, MA, US

• 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)2024-08-16
• K231031 — ACL TOP Family 70 Series2023-06-21
• K160276 — ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)2016-03-03
• K091980 — ACL TOP 700 LAS2009-09-22
• K073377 — ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)2008-05-04

• K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM2023-09-29
• K223187 — HemosIL Liquid Anti-Xa2023-06-23
• K223090 — GEM Premier ChemSTAT2023-01-27
• K223402 — HemosIL von Willebrand Factor Antigen2022-12-09
• K213464 — HemosIL Liquid Anti-Xa2022-10-04

• Z-2578-2023 — ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097Class II·Ongoing·Instrumentation Laboratory·20230713

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150877.