ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770

• K Number: K020914
• Device Name: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
• Manufacturer: HELENA LABORATORIES
• Date Cleared: 2002-05-23 ( 63 days)
• Product Code: JBP
• Regulation Number: 864.7140
• Type: Traditional
• Panel: HE
• Reference & Predicate Devices: N/A

Intended Use

The Actalyke XL Activated Clotting Time Analyzer and Test Tubes are indicated for use in the measurement of the activated clotting time test (ACT). This system can be used in bypass surgery, vascular surgery, transplant surgery, cardiac catheterization, and coronary angioplasty.

Device Description

Not Found

AI/ML Overview

This is an FDA Premarket Notification (510(k)) letter for the Actalyke® XL Analyzer. It does not contain the detailed study information required to complete your request.

The 510(k) summary (or the full submission, which is not provided here) is where you would typically find the acceptance criteria, study design, and performance data to support substantial equivalence. The letter itself is simply the FDA's decision regarding the premarket notification.

Therefore, I cannot provide the requested information from the text provided.

Regulation Number and Section

§ 864.7140 Activated whole blood clotting time tests.

(a)
Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.(b)
Classification. Class II (performance standards).