510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100496Substantially Equivalent

Invader Mthfr 1298

Hologic, Inc., Malborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100496 is the FDA 510(k) clearance record for INVADER MTHFR 1298, a class II device, cleared for Hologic, Inc. on under FDA product code OMM (Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr). FDA's definition for product code OMM reads: "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". FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K100496.

Clearance record

Decision date
Received
(427 days to decision)
Product code
OMM Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
Regulation
21 CFR 864.7280
Device class
Class II
Review panel
Hematology
Applicant
Hologic, Inc. 250 Campus Dr., Malborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMM

Trailing 12 months

FDA records hold no clearances under product code OMM in the trailing twelve months.

FDA records show no clearances under product code OMM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260