510(k) · Cleared
ClearedBD MAX Check-Points CPO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Check-Points Health B.V. · POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Cleared on Aug 29, 2019 as substantially equivalent to K160901 (Cepheid, 2016) after a 171-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Aug 29, 2019
- Review
- 171 days
- Class
- Class II
- Product code
- POC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K972359 (1997). No later device cites it as a predicate yet.
- Root · 5 generations backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
- 4 generations backK061686 Idi-Vanr AssayGeneohm Sciences Canada, Inc. · 2006
- 3 generations backK092953 Xpert VanA AssayCepheid · 2009
- 2 generations backK152614 Xpert Carba-RCepheid · 2016
- 1 generation backK160901 Xpert Carba-RCepheid · 2016
- This deviceK190613 BD MAX Check-Points CPOCheck-Points Health B.V. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin | Remel, L.P. | 1997 | 1 |
| −4 | K061686 | Idi-Vanr Assay | Geneohm Sciences Canada, Inc. | 2006 | — |
| −3 | K092953 | Xpert VanA Assay | Cepheid | 2009 | — |
| −2 | K152614 | Xpert Carba-R | Cepheid | 2016 | — |
| −1 | K160901 | Xpert Carba-R | Cepheid | 2016 | — |
| 0 (this device) | K190613 | BD MAX Check-Points CPO | Check-Points Health B.V. | 2019 | — |
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 |
|---|---|---|---|
| * | K160901 | Xpert Carba-RSummary page 5…=== 5. Substantial Equivalence Information: Predicate Device Name Manufacturer Predicate 510(k) Number Xpert® Carba-R Assay Cepheid, Inc. K160901 Comparison with Predicate: Device Predicate Name… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K160901.
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. 2019, 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 BD MAX Check-Points CPO Assay performed on the BD MAX System is a qualitative, automated in vitro diagnostic real-time PCR test designed for the detection and differentiation of the carbapenemase genes blaKPC, blaNDM, blaVIM/blaIMP and blaOXA-48, that are associated with carbapenem non-susceptibility in Gram-negative bacteria. The assay does not distinguish between the blaVIM and blaIMP genes. The BD MAX Check-Points CPO Assay is intended as an aid…
Read the full statement (186 words)
The BD MAX Check-Points CPO Assay performed on the BD MAX System is a qualitative, automated in vitro diagnostic real-time PCR test designed for the detection and differentiation of the carbapenemase genes blaKPC, blaNDM, blaVIM/blaIMP and blaOXA-48, that are associated with carbapenem non-susceptibility in Gram-negative bacteria. The assay does not distinguish between the blaVIM and blaIMP genes.
The BD MAX Check-Points CPO Assay is intended as an aid to infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The BD MAX Check-Points CPO Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections. A negative BD MAX Check-Points CPO Assay result does not preclude the presence of other resistance mechanisms.
Testing is performed on rectal swabs from patients at risk for intestinal colonisation with carbapenem non-susceptible bacteria. This test is intended for use in conjunction with clinical presentation, laboratory findings, and epidemiological information. Results of this test should not be used as the sole basis for patient management decisions. Concomitant cultures are necessary to recover organisms for epidemiological typing, antimicrobial susceptibility testing, and for further confirmatory bacterial identification.
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/K190613 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190613: BD MAX Check-Points CPO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190613
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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