K100987 is an FDA 510(k) clearance for the INVADER MTHFR 677. 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 May 13, 2011, 399 days after receiving the submission on April 9, 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 | K100987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2010 |
| Decision Date | May 13, 2011 |
| Days to Decision | 399 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. |