(136 days)
ProC APC is intended for the determination of the activated Protein C sensitivity of the activated partial thromboplastin time (aPTT) in citrated human plasma.
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).
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.
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DEC 1 3 1996
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For ProC APC
1. Manufacturer and Contact Information:
| Manufacturer: | Behringwerke AGPostfach 114035001 Marburg, Germany |
|---|---|
| --------------- | ------------------------------------------------------------ |
Contact Information:
Paul Rogers Behring Diagnostics Inc. 3403 Yerba Buena Road P.O. Box 49013 San Jose, CA 95161-9013 Tel: 408-239-2000
2. Device Classification Name:
The ProC APC is a Class II device and has a classification name of partial thromboplastin time test (21 CFR §864.7925).
3. 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 and Characteristics: ব
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). This is similar to the Chromogenix Coatest APC Resistance-C (Coatest APC) assay, the predicate device, which consists a liquid aPTT reagent (phospholipids, silica-based activator), a lyophilized APC/CaC12 reagent (activated human Protein C), and two lyophilized Control Plasmas (for normal and pathological ranges),
Comparative Analysis: A total of 116 plasma samples (22 Factor V Leiden carriers, 94 normal blood donors) were tested by the ProC APC and the Coatest APC Resistance-C. The ProC APC correctly identified the 116 samples as either having normal (Factor V Leiden) APC sensitivities. The Coatest APC identified 20 of the 22 Factor V Leiden samples as having abnormal APC sensitivities and 92 of the 94 normal blood donor samples as having normal APC sensitivities.
Precision: Precision studies were performed following the NCCLS EP5 guideline using two plasma samples which were in the normal and abnormal APC sensitivity ranges. The within-run precision ranged from 1.7 to 2.9%. The total precision ranged from 2.5 to 7.3%.
5. Substantial Equivalence:
Behring Diagnostics Inc. considers the ProC APC to be substantially equivalent to the Chromogenix Coatest APC Resistance-C in terms of intended use, reagent composition, and overall performance characteristics.
§ 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).