(31 days)
The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene, from DNA isolated from human whole peripheral blood. The test is intended to be used on the LightCycler using SW 3.5. The sample preparation must be performed according to the workflow procedure described in the package insert. The Factor II (Prothrombin) G20210A Kit is indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation, from DNA isolated from human whole peripheral blood.
Acceptance Criteria and Device Performance Study for K033612
This analysis describes the acceptance criteria and the study used to demonstrate that the Factor II (Prothrombin) G20210A Kit meets these criteria, as detailed in the provided 510(k) summary (K033612).
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | High agreement with a DNA sequencing method. | 99.5% agreement with a DNA sequencing method. |
| Precision | Consistent and reproducible results. | Within-run: Tm1: 0.14 – 0.26 % CV, Tm2: 0.14 – 0.24 % CV, ΔTm: 0.58- 0.90% CV |
| Total: Tm1: 0.19 – 0.33 % CV, Tm2: 0.22 – 0.44 % CV, ΔTm: 1.23- 1.53 % CV | ||
| Overall median: 0.36% | ||
| Analytical Sensitivity (LDL) | Ability to detect low concentrations of allele copies. |
§ 864.7280 Factor V Leiden DNA mutation detection systems.
(a)
Identification. Factor V Leiden deoxyribonucleic acid (DNA) mutation detection systems are devices that consist of different reagents and instruments which include polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection of the Factor V Leiden mutation aids in the diagnosis of patients with suspected thrombophilia.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems.” (See § 864.1(d) for the availability of this guidance document.)