21 CFR 864.7280 — Test, Factor V Leiden Mutations, Genomic Dna Pcr
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7280
Identification
Factor V Leiden mutation detection system is a device that allows the detection and genotyping of a single point mutation of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The system consists of different reagents and instruments which includes polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection system is an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Classification Rationale
FDA concludes that this device, and substantially equivalent devices of this generic type, should be classified into class II. FDA has determined that the Factor V Leiden Kit can be classified in class II with the establishment of special controls, which provide reasonable assurance of the safety and effectiveness of the device type.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NPQ | Test, Factor V Leiden Mutations, Genomic Dna Pcr | 2 | 6 | |
| NPR | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr | 2 | 5 | |
| OMM | Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr | 2 | 2 | 3rd Party |
| PHJ | System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations | 2 | 1 |
Special Controls
NPQ — Test, Factor V Leiden Mutations, Genomic Dna Pcr
*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.)
eCFR
NPR — Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
*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.)
eCFR
OMM — Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
*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.)
eCFR
PHJ — System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
*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.)
eCFR
