CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)

• K Number: K990296
• Device Name: CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
• Manufacturer: PRECISION BIOLOGIC
• Date Cleared: 1999-03-18 ( 49 days)
• Product Code: GJT
• Regulation Number: 864.7290
• Type: Traditional
• Panel: HE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Prekallikrein or Fletcher factor, is a single chain polypeptide with a molecular weight of 85,000 and is necessary for normal coagulation of the "intrinsic coagulation pathway". Prekallikrein deficiency is commonly diagnosed in vitro through the use of the activated partial thromboplastin time (APTT), an intrinsic pathway screening assay and confirmed with a quantitative prekallikrein assay which is an APTT-based clotting assay.

Cryo Check™ Prekallikrein Deficient Plasma is human plasma deficient in the prekallikrein coagulation protein. It is recommended for use as a substrate in clot-based prekallikrein assays using the activated partial thromboplastin time (APTT).

Device Description

Cryo Check™ Prekallikrein Deficient Plasma is human plasma deficient in the prekallikrein coagulation protein.

AI/ML Overview

I am sorry, but based on the limited information provided in the regulatory letter, I cannot describe the acceptance criteria or the study. The document is a 510(k) clearance letter from the FDA, which confirms that the "Cryo | Check™ Prekallikrein Deficient Plasma" device is substantially equivalent to a legally marketed predicate device.

This type of document does not typically contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, or specific performance metrics. The letter confirms clearance based on a prior submission, but the actual data and study details are not part of this public clearance announcement.

Therefore, I cannot provide the requested table or answer the specific questions about the study from the given 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).