HEMOCHRON CITRATE APTT

• K Number: K972831
• Device Name: HEMOCHRON CITRATE APTT
• Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
• Date Cleared: 1997-11-20 ( 113 days)
• Product Code: GFO , JPA
• Regulation Number: 864.7925
• Type: Traditional
• Panel: HE
• Reference & Predicate Devices: N/A

Intended Use

The HEMOCHRON® Jr. Citrate APTT is a unitized microcoagulation test intended for in vitro diagnostic use in performing a quantitative, one-stage Activated Partial Thromboplastin Time (APTT). The APTT test is used for monitoring of low dose heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the HEMOCHRON® Jr. microcoagulation instrument. The instrument is portable and is intended for point-of-care testing. The HEMOCHRON® Jr. is not intended for home use.

Device Description

Not Found

AI/ML Overview

This letter is an FDA clearance letter from 1997 for the Hemochron Citrate APTT, an in-vitro diagnostic device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for that information based solely on the provided text. The document only confirms the device's substantial equivalence to a predicate device and its intended use.

Regulation Number and Section

§ 864.7925 Partial thromboplastin time tests.

(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).