(359 days)
CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use
CRYOcheck Factor VIII Deficient Plasma with VWF is normal human citrated plasma which has been immunodepleted of factor VIII and to which an exogenous source of human von Willebrand Factor (vWF) has been added and buffered with HEPES. Factor VIII has been assayed at less than 1% of normal activity levels and vWF antigen and activity are >50%. It will be provided to users frozen in small-volume aliquots (25 vials of 1.0 mL, and 25 vials of 1.5 mL). Vials will be packaged into boxes; these will be frozen during the manufacturing process and will be shipped and stored frozen until use to preserve the integrity of the components
The provided FDA 510(k) summary for the "CRYOcheck Factor VIII Deficient Plasma with VWF" describes various performance studies and their results. Based on the document, here's a structured breakdown of the acceptance criteria and the study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of pre-defined acceptance criteria for each performance characteristic in a pass/fail format. Instead, it presents the results of various studies and implies that these results met internal or regulatory expectations for substantial equivalence to the predicate device. However, we can infer performance targets based on the documented results and common regulatory expectations for in vitro diagnostic devices.
Here's a table summarizing the reported device performance, with inferred acceptance "criteria" based on the conclusions drawn in the report:
| Performance Characteristic | Inferred Acceptance Criteria (Based on reported success) | Reported Device Performance |
|---|---|---|
| Precision (Multi-Reagent Lot) |
§ 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).