# K061014: Actalyke QC Kit, Models  Aqc-HP and Aqc-LP

- Pathway: 510(k) (Special)
- Applicant: Helena Laboratories
- Decided: May 10, 2006 after 27 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Nov 9, 2020 · Class II · Z-0635-2021: Due to complaints received associated with cracked/split test tube caps.

## Indications for use
The Actalyke QC Kits are used to perform quality control assays when using the Actalyke Activated Clotting Time test systems. Blood coagulation instruments and test systems are used in hospitals and/or catherization labs. The AQC-LP is used as a control when the Actalyke system monitors moderately heparinized patients undergoing ECMO procedures or renal dialysis. The AQC-HP is used for QC testing when the Actalyke system is monitoring normal and highly heparinized patients undergoing cardiovascular procedures.

Source page: https://510kreport.com/device/K061014
Methodology: https://510kreport.com/methodology