Cleared Traditional

cobas Factor II and Factor V Test

K172913 · Roche Molecular Systems, Inc. · Hematology
Jan 2018
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K172913 is an FDA 510(k) clearance for the cobas Factor II and Factor V Test, a Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (Class II — Special Controls, product code NPR), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 12, 2018, 109 days after receiving the submission on September 25, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7280.

Submission Details

510(k) Number K172913 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2017
Decision Date January 12, 2018
Days to Decision 109 days
Submission Type Traditional
Review Panel Hematology (HE)
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.