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K Number
K061014
Device Name
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
Manufacturer
HELENA LABORATORIES
Date Cleared
2006-05-10

(27 days)

Product Code
JPA
Regulation Number
864.5425
Type
Special
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

Not Found

AI/ML Overview

This document section appears to be an FDA 510(k) clearance letter for a medical device called "Actalyke® QC Kits QAC-HP, AQC-LP." It confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding the acceptance criteria, device performance data, study details, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related information requested.

The document primarily focuses on:

  • The FDA's decision of substantial equivalence.
  • The regulatory classification of the device.
  • General controls and regulations applicable to the device.
  • The intended use of the device: "The Actalyke QC Kits are used to perform quality control assays when using the Actalyke Activated Clotting Time test systems."

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided document. This type of detailed study data is typically found in the 510(k) submission itself or in separate technical reports, not usually in the FDA clearance letter.

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.