510(k) · Cleared
Recalled · Class II · 2025Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · PEU System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
Cleared on Feb 12, 2015 as substantially equivalent to DEN130032 (Cepheid, 2013) after an 87-day review. Its family tree reaches back 1 generation to 2013. It has been recalled once.
- Decided
- Feb 12, 2015
- Review
- 87 days
- Class
- Class II
- Product code
- PEU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130032 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backDEN130032 Xpert MTB/Rif AssayCepheid · 2013
- This deviceK143302 Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert…Cepheid · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130032 | Xpert MTB/Rif Assay | Cepheid | 2013 | — |
| 0 (this device) | K143302 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert… | Cepheid | 2015 | — |
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 PEU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 | Decided |
|---|---|---|---|
| * | DEN130032 | Xpert MTB/Rif Assay Our reading of the summary gave K131706, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130032, Xpert MTB/Rif Assay (Cepheid), granted Jul 25, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2013 |
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 |
|---|---|---|---|---|
| Nov 5, 2025 | Class II | Z-0724-2026 | Under Investigation by firm | Product testing did not meet expected stability criteria. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All PEU devicesPEU System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PEU
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · PEU
Too few PEU 510(k)s in any year since 2007 to give a median.
Recalls per year · PEU
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEU
1in 2025
MAUDE reports naming product code PEU, 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 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Xpert® MTB/RIF Assay, performed on the GeneXpert® Instrument Systems, is a qualitative, nested real-time polymerase chain reaction (PCR) in vitro diagnostic test for the detection of Mycobacterium tuberculosis complex DNA in raw sputum or concentrated sputum sediment prepared from induced or expectorated sputum. In specimens where Mycobacterium tuberculosis complex (MTB-complex) is detected, the Xpert MTB/RIF Assay also detects the…
Read the full statement (460 words)
The Xpert® MTB/RIF Assay, performed on the GeneXpert® Instrument Systems, is a qualitative, nested real-time polymerase chain reaction (PCR) in vitro diagnostic test for the detection of Mycobacterium tuberculosis complex DNA in raw sputum or concentrated sputum sediment prepared from induced or expectorated sputum.
In specimens where Mycobacterium tuberculosis complex (MTB-complex) is detected, the Xpert MTB/RIF Assay also detects the rifampin-resistance associated mutations of the rpoB gene.
The Xpert MTB/RIF Assay is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than three days of therapy. This test is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.
An Xpert MTB/RIF Assay result of “MTB NOT DETECTED” from either one or two sputum specimens is highly predictive of the absence of M. tuberculosis complex bacilli on serial fluorescent acid-fast sputum smears from patients with suspected active pulmonary tuberculosis and can be used as an aid in the decision of whether continued airborne infection isolation (AII) is warranted in patients with suspected pulmonary tuberculosis. The determination of whether testing of either one or two sputum specimens is appropriate for decisions regarding removal from AII should be based on specific clinical circumstances and institutional guidelines. Clinical decisions regarding the need for continued AII should always occur in conjunction with other clinical and laboratory evaluations and Xpert MTB/RIF Assay results should not be the sole basis for infection control practices.
The Xpert MTB/RIF Assay must always be used in conjunction with mycobacterial culture to address the risk of false negative results and to recover organisms when MTB-complex is present for further characterization and drug susceptibility testing. However, decisions regarding the removal of patients from AII need not wait for culture results. Sputum specimens for TB culture, AFB smear microscopy, and Xpert MTB/RIF Assay testing should follow CDC recommendations with regard to collection methods and time frame between specimen collection.
The Xpert MTB/RIF Assay does not provide confirmation of rifampin susceptibility since mechanisms of rifampin resistance other than those detected by this device may exist that may be associated with a lack of clinical response to treatment.
Specimens that have both MTB-complex DNA and rifampin-resistance associated mutations of the rpoB gene detected by the Xpert MTB/RIF Assay must have results confirmed by a reference laboratory. If the presence of rifampin-resistance associated mutations of the rpoB gene is confirmed, specimens should also be tested for the presence of genetic mutations associated with resistance to other drugs.
The Xpert MTB/RIF Assay should only be performed in laboratories that follow safety practices in accordance with the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories publication and applicable state or local regulations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143302: Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143302
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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