CRYO CHECK FACTOR IX DEFICIENT PLASMA

• K Number: K971226
• Device Name: CRYO CHECK FACTOR IX DEFICIENT PLASMA
• Manufacturer: PRECISION BIOLOGICALS, INC.
• Date Cleared: 1997-07-18 ( 107 days)
• Product Code: GJT
• Regulation Number: 864.7290
• Type: Traditional
• Panel: HE
• Reference & Predicate Devices: N/A

Intended Use

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

Device Description

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

AI/ML Overview

This document, a 510(k) clearance letter for the CryoCheck Factor IX Deficient Plasma, does not contain the requested information about acceptance criteria and the study proving the device meets those criteria.

The letter is a regulatory document from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It focuses on:

• Regulatory classification: Class II, Product Code GJT.
• Substantial equivalence: The FDA's determination that the device is as safe and effective as a predicate device.
• Compliance requirements: Mentioning general controls, GMP, and other regulations.
• Instructions for marketing: Allowing the manufacturer to market the device.
• Contact information: For further regulatory questions.
• Indications for Use: Briefly describing what the device is used for.

The information you are looking for (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) would typically be found in the 510(k) summary or the detailed study reports submitted by the manufacturer to the FDA, not in the clearance letter itself.

Therefore, I cannot provide a table of acceptance criteria, device performance, or details about the study, as that information is not present in the provided text.

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).