CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)

• K Number: K981174
• Device Name: CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
• Manufacturer: PRECISION BIOLOGICALS, INC.
• Date Cleared: 1999-01-13 ( 287 days)
• Product Code: GJT
• Regulation Number: 864.7290
• Type: Traditional
• Panel: HE
• Reference & Predicate Devices: K900412

Intended Use

CryovCheck™ Factor XII Deficient Plasma is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) assay.

Device Description

Cryo✓Check™ Factor XII Deficient Plasma is frozen human plasma deficient in the Factor XII coagulation factor. It is prepared from citrated pooled normal human plasma which has been depleted of Factor XII by immunoadsorption. Activity levels of Factor XII are assayed at less than 1% normal levels while all other coagulation factors are greater than 50%.

AI/ML Overview

Acceptance Criteria and Study Details for Cryo✓Check™ Factor XII Deficient Plasma

The device's performance was evaluated through an "Open Vial Stability" study.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (24 Hours)
Mean (+/-) 5% of reference value	93 (within 5% of reference value, as 92.9% is the overall average)
%C.V.

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).