(316 days)
Biophen Protein C 5 & 2.5 kit is a Chromogenic assay for measuring the Protein C Activity in human citrated plasma using a manual or an automated method. Biophen Protein C 5 & 2.5 Kit is a Chromogenic assay for measuring the Protein C Activity in human citrated plasma using a manual or an automated method.
Biophen Protein C is a chromogenic assay consisting of chromogenic substrate and Protein C activator.
This document describes a 510(k) submission for the "Biophen Protein C 5 & 2.5" device, a chromogenic assay for the quantitative determination of Protein C activity in human plasma. The submission focuses on demonstrating substantial equivalence to a predicate device, the "Coamatic Protein C".
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the Biophen Protein C device. Instead, it presents performance data for "Intra-Assay CV%" and "Inter-Assay CV%", which are common metrics for assay precision. The implication is that these performance characteristics are considered acceptable due to their similarity to the predicate device, which is already legally marketed.
| Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Biophen Protein C 5 & 2.5) |
|---|---|---|
| Intra-Assay CV% | Not explicitly stated; likely |
§ 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).