CRYO CHECK FACTOR VII DEFICIENT PLASMA

• K Number: K971224
• Device Name: CRYO CHECK FACTOR VII DEFICIENT PLASMA
• Manufacturer: PRECISION BIOLOGICALS, INC.
• Date Cleared: 1997-07-17 ( 106 days)
• Product Code: GJT
• Regulation Number: 864.7290
• Type: Traditional
• Panel: HE
• Reference & Predicate Devices: N/A

Intended Use

CryoCheck Factor VII Deficient Plasma is human plasma deficient in the factor VII coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VII deficiencies in in vitro clot-based factor VII assays using the one stage prothrombin time.

Device Description

CryoCheck Factor VII Deficient Plasma is human plasma deficient in the factor VII coagulation protein while having all other coagulation factors within normal limits.

AI/ML Overview

This document does not contain the information required to answer your request. It is a 510(k) clearance letter for a medical device (CryoCheck Factor VII Deficient Plasma), which primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance. It does not include details on acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment.

Regulation Number and Section

§ 864.7290 Factor deficiency test.

(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).