PROC APC ASSAY, PROC CONTROL PLASMA

• K Number: K962968
• Device Name: PROC APC ASSAY, PROC CONTROL PLASMA
• Manufacturer: BEHRING DIAGNOSTICS, INC.
• Date Cleared: 1996-12-13 ( 136 days)
• Product Code: GGP
• Regulation Number: 864.7290
• Type: Traditional
• Panel: Hematology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

ProC APC is intended for the determination of the activated Protein C sensitivity of the activated partial thromboplastin time (aPTT) in citrated human plasma.

Device Description

The ProC APC assay consists of a liquid aPTT Reagent (containing phospholipids, silica-based activator), a lyophilized activated Protein C time (APCT) Reagent (containing activated human Protein C), and lyophilized Control Plasma (in the pathological range).

AI/ML Overview

This document describes the ProC APC assay, a device for determining activated Protein C sensitivity. However, this is a lab diagnostic test, not an AI/ML device, so it doesn't fit the requested format which pertains to AI/ML device studies. Factors like "sample size used for the test set and the data provenance," "number of experts used to establish the ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," and "sample size for the training set" are not applicable to the description of this device.

Therefore, I cannot fulfill the request in the specified format.

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).