Actalyke QC Kit, Models AQC-HP and AQC-LP
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061014 FDA 510(k)
- FDA Product Code
- JPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5425 FDA 510(k)
- Regulation Number
- 864.5425 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Actalyke QC Kit, Models AQC-HP and AQC-LP, is a system for in vitro coagulation studies, designed to monitor activated clotting time (ACT) in patient samples. These kits serve as quality control references for assessing coagulation parameters in heparinized and non-heparinized blood during procedures such as cardiopulmonary bypass, dialysis, and cardiovascular interventions.
The AQC-HP and AQC-LP models are supplied as single-use quality control materials for use with the Actalyke system, a point-of-care device. Both models are intended for hematology applications and have received FDA 510(k) clearance under Special Controls for Class II devices (product code JPA). They are not sterile and must be stored according to manufacturer instructions prior to use.
Frequently asked questions
What clinical procedures is the Actalyke QC Kit designed to support during coagulation monitoring?
The Actalyke QC Kit (Models AQC-HP and AQC-LP) is specifically designed for in vitro coagulation studies to monitor activated clotting time (ACT) in patient samples. It is used as a quality control reference during procedures like cardiopulmonary bypass, dialysis, and cardiovascular interventions where coagulation parameters—particularly in heparinized or non-heparinized blood—need precise assessment.
Are the Actalyke QC Kits single-use or reusable, and what does that mean for my workflow?
The Actalyke QC Kits (AQC-HP and AQC-LP) are explicitly labeled as single-use quality control materials. This means each kit is intended for one-time use with the Actalyke system, ensuring consistent and reliable results without cross-contamination risks. After use, they should be discarded, and a new kit opened for subsequent testing.
How should I store the Actalyke QC Kits before use, and why does this matter?
The kits must be stored according to the manufacturer’s instructions prior to use, though the data does not specify exact conditions (e.g., temperature or humidity). Proper storage is critical because these are non-sterile quality control materials, and incorrect handling could compromise their stability or accuracy for monitoring ACT in patient samples.
What regulatory pathway was followed for FDA clearance of the Actalyke QC Kits, and how does that affect their use?
The Actalyke QC Kits received FDA 510(k) clearance under Special Controls for Class II devices, with the product code JPA and advisory committee HE (Hematology). This classification means they are subject to additional scrutiny for hematology applications, ensuring their safety and effectiveness for quality control in coagulation studies—particularly in procedures like cardiopulmonary bypass where precision matters.
Are there different models of the Actalyke QC Kit, and how do I know which one to choose for my lab?
Yes, there are two models: AQC-HP and AQC-LP. While the exact differences between them aren’t detailed in the data, the naming convention suggests they may be tailored for specific clinical scenarios (e.g., high-performance vs. low-performance applications). Consult the manufacturer’s documentation or your lab’s established protocols to determine which model aligns with your ACT monitoring needs for heparinized or non-heparinized blood.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP - fda.innolitics.com, K061014 FDA 510(k) - ACTALYKE QC KIT | Helena Laboratories, Actalyke and MAX-ACT | Helena Laboratories - Innovations for Science ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061014 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K061014 24 fields · synced Sep 19, 2026