K100496 is an FDA 510(k) clearance for the INVADER MTHFR 1298. This device is classified as a Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr (Class II - Special Controls, product code OMM).
Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Cleared decision on April 25, 2011, 427 days after receiving the submission on February 22, 2010.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.7280. 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..
| 510(k) Number | K100496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2010 |
| Decision Date | April 25, 2011 |
| Days to Decision | 427 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | OMM — Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7280 |
| Definition | 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. |