Cleared Traditional

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

K190076 · Cepheid · Pathology
Sep 2019
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K190076 is an FDA 510(k) clearance for the Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, a Bcr/abl1 Monitoring Test (Class II — Special Controls, product code OYX), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on September 27, 2019, 254 days after receiving the submission on January 16, 2019. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6060.

Submission Details

510(k) Number K190076 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2019
Decision Date September 27, 2019
Days to Decision 254 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code OYX — Bcr/abl1 Monitoring Test
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6060
Definition A Bcr/abl1 Monitoring Test Is A Quantitative In Vitro Diagnostic Device Used To Monitor The Bcr/abl1 To Abl1 Ratio By Reverse-transcriptase Quantitative Polymerase Chain Reaction (rq-pcr) On Whole Blood Or Bone Marrow Of Diagnosed Philadelphia Chromosome Positive (ph+) Chronic Myeloid Leukemia (cml) Patients Expressing Bcr-abl1 Fusion Transcripts Such As E13a2 And/or E14a2. It Is Intended For Use During Monitoring Of Treatment Response By Reporting Results On The International Scale (%is) And As Log Molecular Reduction (mr) Value.