Product code OMM— Hematology

INVADER MTHFR 1298

Classification name: Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
Device class: Class 2
Regulation: 21 CFR 864.7280
Advisory panel: Hematology
Total cleared: 2
First cleared: 2011-04-25
Most recent: 2011-05-13

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code OMM under 21 CFR 864.7280, via openFDA

Market context for product code OMM

FDA has cleared 2 devices under product code OMM, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OMM

Hologic, Inc.2 clearances

Recent clearances under product code OMM

K100987 — INVADER MTHFR 677Hologic, Inc.·2011-05-13
K100496 — INVADER MTHFR 1298Hologic, Inc.·2011-04-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.