510(k) · Cleared

Recalled · Class II · 2025

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

K190076510(k) TraditionalCleared Sep 27, 2019254-day reviewClass II21 CFR 866.6060Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cepheid · OYX Bcr/Abl1 Monitoring Test

Cleared on Sep 27, 2019 as substantially equivalent to DEN160003 (Asuragen, Inc., 2016) after a 254-day review. Its family tree reaches back 1 generation to 2016. It has been recalled once.

Decided: Sep 27, 2019
Review: 254 days
Class: Class II
Product code: OYX
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to DEN160003 (2016). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backDEN160003 Quantidex qPCR BCR-ABL IS KitAsuragen, Inc. · 2016
This deviceK190076 Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and…Cepheid · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN160003	Quantidex qPCR BCR-ABL IS Kit	Asuragen, Inc.	2016	—
0 (this device)	K190076	Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert…	Cepheid	2019	—

FIG. 1 — Lineage of K190076, 2016–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OYX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OYX device

#1 K252243 Fastplex™ BCR-ABL (p210) %IS digital PCR Kitscore 12.2 · 3 generations · no Class I recall
#2 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN160003	Quantidex qPCR BCR-ABL IS Kit Summary page 4 …Pathology (88) Advisory Panel Prescription Use Yes Predicate Device Asuragen QuantideX qPCR BCR-ABL IS Kit [DEN160003] Xpert BCR-ABL Ultra 510(k) Page 1 Device Intended Use: The X…	Asuragen, Inc.	2016	—

Also cleared against DEN160003: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 30, 2025	Class II	Z-0959-2026	Process design	Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate DEN160003.

How does its category compare?

All OYX devices

OYX Bcr/Abl1 Monitoring Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · OYX

1in 2023

2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OYX

Too few OYX 510(k)s in any year since 2007 to give a median.

Recalls per year · OYX

2in 2025

2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OYX

4in 2025

2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code OYX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	1	—	0	0
2017	1	—	0	0
2018	0	—	0	0
2019	2	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	1	—	0	0
2024	0	—	0	1
2025	0	—	2	4
2026	1	—	0	—

What is it indicated for?

Read the full statement (155 words)

The Xpert BCR-ABL Ultra test is an in vitro diagnostic test for the quantitation of BCR-ABL1 and ABL1 mRNA transcripts in peripheral blood specimens of diagnosed t(9;22) positive Chronic Myeloid Leukemia (CML) patients expressing BCR-ABLl fusion transcripts type e13a2 and/or e14a2. The test utilizes automated, quantitative, real-time reverse transcription polymerase chain reaction (RT-qPCR). The Xpert BCR-ABL Ultra test is intended to measure BCR-ABL1 to ABL1 percent ratios on the International Scale (IS), and also expressed as a log molecular reduction (MR value) from a baseline of 100% (IS), in t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).

The test does not differentiate between e13a2/b2a2 or e14a2/b3a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). This test is not intended for the diagnosis of CML.

The Xpert BCR-ABL Ultra test is intended for use only on the Cepheid GeneXpert® Dx System and the GeneXpert Infinity System.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K190076 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190076: Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190076

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026