Cleared Traditional

INVADER FACTOR II

K100943 · Hologic, Inc. · Pathology

Jun 2011

Decision

422d

Days

Class 2

Risk

About This 510(k) Submission

K100943 is an FDA 510(k) clearance for the INVADER FACTOR II, a Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (Class II — Special Controls, product code NPR), submitted by Hologic, Inc. (Marlborough, US). The FDA issued a Cleared decision on June 2, 2011, 422 days after receiving the submission on April 6, 2010. This device falls under the Pathology review panel. Regulated under 21 CFR 864.7280.

Submission Details

510(k) Number	K100943 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2010
Decision Date	June 02, 2011
Days to Decision	422 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	NPR — Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.7280
Definition	In Vitro Diagnostic Test To Detect The Factor Ii G20210a Mutation In Genomic Dna, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia.