Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems— 510(k) K190076

Name: FDA 510(k) clearance K190076
Creator: U.S. Food and Drug Administration
Published: 2019-09-27

Substantially Equivalent

Cepheid

FDA 510(k) clearance K190076 for Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, Substantially Equivalent on 2019-09-27. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code OYX
Device class: Class 2
Regulation: 21 CFR 866.6060
Advisory panel: Medical Genetics
Date received: 2019-01-16
Decision date: 2019-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K190076

K-number listed on FDA's recall record

Z-0959-2026 — Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10Class II·Ongoing·Cepheid·20251030

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190076.

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