510(k) K100496
K100496 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "INVADER MTHFR 1298". The FDA issued a decision of Substantially Equivalent on April 25, 2011. The device falls under product code OMM (Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr), a Class II device regulated under 21 CFR 864.7280. Hologic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2011
- Date Received
- February 22, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
- Device Class
- Class II
- Regulation Number
- 864.7280
- Review Panel
- HE
- Submission Type
In vitro diagnostic for the detection and genotyping of a single point mutation of the human 5, 10-methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia.