510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190076Substantially Equivalent

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

Cepheid, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190076 is the FDA 510(k) clearance record for Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, a class II device, cleared for Cepheid on under FDA product code OYX (Bcr/Abl1 Monitoring Test). FDA's definition for product code OYX reads: "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...". FDA records list 62 510(k) clearances for Cepheid, from to . As of , FDA records show one recall naming K190076.

Clearance record

Decision date
Received
(254 days to decision)
Product code
OYX Bcr/Abl1 Monitoring Test
Regulation
21 CFR 866.6060
Device class
Class II
Review panel
Medical Genetics
Applicant
Cepheid 904 Caribbean Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OYX

Trailing 12 months
1 clearance under product code OYX in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OYX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260