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- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
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System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
- Page Type
- Product Code
- Definition
- A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry. It is intended as an aid in diagnosis of patients with suspected thrombophilia.
- Physical State
- A qualitative multiplex amplification-based genotyping test system. Should not include any devices other than mass spectrometry-based detection systems.
- Technical Method
- The assay uses multiplex polymerase chain reaction and allele specific single base primer extension reactions to amplify and detect specific mutations located in the Factor V and prothrombin genes. Genotyped products are resolved according to mass by mass spectrometry.
- Target Area
- Human peripheral whole blood or other clinical samples.
- Regulation Medical Specialty
- Hematology
- Review Panel
- Pathology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 864.7280
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 864.7280 Factor V Leiden DNA mutation detection systems
§ 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.)
[69 FR 12273, Mar. 16, 2004]