# K964609: Actalyke Activated Clotting Time Test System/Clotting Time Tubes/Whole Blood QC Kit/Actalyke Electronic Clotting Tube

- Pathway: 510(k) (Traditional)
- Applicant: Array Medical, Inc.
- Decided: Mar 6, 1997 after 108 days
- Product code: JBP (Activated Whole Blood Clotting Time)
- Device class: 2
- Regulation: 21 CFR 864.7140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HEMOCHRON Whole Blood Coagulation System and Activated Clotting Time Tests (pre-1976): named in the summary without a submission number

## Most influential descendants
- K983649: Max-Act (1998), 0 descendants of its own

## Indications for use
The Actalyke Activated Clotting Time System and Test Tubes are intended for use in the measurement of the activated clotting time test (ACT). Current markets using the ACT include: bypass surgery, vascular surgery, transplant surgery, renal dialysis, ECMO, cardiac catheterization and Percutaneous Transluminal Coronary Angioplasty (PTCA), Critical Care, and other medical therapies requiring heparin anticoagulation.

Source page: https://510kreport.com/device/K964609
Methodology: https://510kreport.com/methodology