510(k) · Cleared
ClearedXpert Carba-R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Cleared on Jun 29, 2016 as substantially equivalent to K152614 (Cepheid, 2016) after an 89-day review. Its family tree reaches back 4 generations to 1997. 3 later devices descend from it.
- Decided
- Jun 29, 2016
- Review
- 89 days
- Class
- Class II
- Product code
- POC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972359 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
- 3 generations backK061686 Idi-Vanr AssayGeneohm Sciences Canada, Inc. · 2006
- 2 generations backK092953 Xpert VanA AssayCepheid · 2009
- 1 generation backK152614 Xpert Carba-RCepheid · 2016
- This deviceK160901 Xpert Carba-RCepheid · 2016
- Descendant · cites it directly · 1 of its ownK173263 Xpert Carba-RCepheid · 2018
- Descendant · 2 generations on · 0 of its ownK261867 Xpert Carba-RCepheid® · 2026
- Descendant · cites it directly · 0 of its ownK190613 BD MAX Check-Points CPOCheck-Points Health B.V. · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin | Remel, L.P. | 1997 | 1 |
| −3 | K061686 | Idi-Vanr Assay | Geneohm Sciences Canada, Inc. | 2006 | — |
| −2 | K092953 | Xpert VanA Assay | Cepheid | 2009 | — |
| −1 | K152614 | Xpert Carba-R | Cepheid | 2016 | — |
| 0 (this device) | K160901 | Xpert Carba-R | Cepheid | 2016 | — |
| +1 | K173263 | Xpert Carba-R | Cepheid | 2018 | — |
| +2 | K261867 | Xpert Carba-R | Cepheid® | 2026 | — |
| +1 | K190613 | BD MAX Check-Points CPO | Check-Points Health B.V. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 1 | 0 |
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 POC? 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 POC device
- #1 K261867 Xpert Carba-Rscore 13.1 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K152614 | Xpert Carba-RSummary page 4…sification Microbiology (83) Advisory Panel Prescription Use Yes Predicate Device Cepheid Xpert ® Carba-R Assay: [510(k) #K152614] Page 1 Device Description: The Xpert Carba-R Assay is an autom… | 2016 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K173263 (Cepheid, 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K152614.
How does its category compare?
All POC devicesPOC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · POC
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · POC
Too few POC 510(k)s in any year since 2007 to give a median.
Recalls per year · POC
No recall names POC since 2007.
Adverse event reports per year · POC
1in 2025
MAUDE reports naming product code POC, 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 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptibility. The test utilizes automated real-time polymerase chain reaction (PCR). The Xpert Carba-R Assay is intended as an aid to infection control in the detection of…
Read the full statement (199 words)
The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptibility. The test utilizes automated real-time polymerase chain reaction (PCR).
The Xpert Carba-R Assay is intended as an aid to infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections. A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms.
The Xpert Carba-R Assay is for use with the following sample types:
Rectal Swab Specimens
The assay is performed on rectal swab specimens from patients at risk for intestinal colonization with carbapenem-non-susceptible bacteria. Concomitant cultures are necessary to recover organisms for epidemiological typing, antimicrobial susceptibility testing, and for further confirmatory bacterial identification.
Pure Colonies
The assay is performed on carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. For testing pure colonies, the Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160901: Xpert Carba-R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160901
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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