510(k) · Cleared
ClearedAcuitas AMR Gene Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opgen, Inc. · PMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
Cleared on Sep 30, 2021 as substantially equivalent to K152614 (Cepheid, 2016) after an 871-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Sep 30, 2021
- Review
- 871 days
- Class
- Class II
- Product code
- PMY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972359 (1997). No later device cites it as a predicate yet.
- 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 deviceK191288 Acuitas AMR Gene PanelOpgen, Inc. · 2021
View 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) | K191288 | Acuitas AMR Gene Panel | Opgen, Inc. | 2021 | — |
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 PMY? 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 |
|---|---|---|---|
| * | K152614 | Xpert Carba-RSummary page 7…OI - Real-time nucleic acid amplification system E. PREDICATE DEVICE The Acuitas AMR Gene Panel is substantially equivalent to the Cepheid Xpert® Carba-R [510(k) # K152614]. F. DEVICE DESCRIPTION The Acuitas® AMR Gene Panel is a qualitative nucleic acid-based in vitro diagnostic test capable of… | 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 24 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K152614.
How does its category compare?
All PMY devicesPMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PMY
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PMY
Too few PMY 510(k)s in any year since 2007 to give a median.
Recalls per year · PMY
No recall names PMY since 2007.
Adverse event reports per year · PMY
No MAUDE report names PMY since 2007.
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 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Acuitas® AMR Gene Panel, performed on the QIAGEN® EZ1® Advanced XL System and the OpGen Qualified QuantStudio™ 5 Real-Time PCR System, is a qualitative nucleic acid-based multiplex in vitro diagnostic test for detection and differentiation of antibiotic resistance markers to one or more antimicrobial agents. The test utilizes real‐time polymerase chain reaction (PCR) and is performed on isolated colonies of Pseudomonas aeruginosa, Enterococcus…
Read the full statement (390 words)
The Acuitas® AMR Gene Panel, performed on the QIAGEN® EZ1® Advanced XL System and the OpGen Qualified QuantStudio™ 5 Real-Time PCR System, is a qualitative nucleic acid-based multiplex in vitro diagnostic test for detection and differentiation of antibiotic resistance markers to one or more antimicrobial agents. The test utilizes real‐time polymerase chain reaction (PCR) and is performed on isolated colonies of Pseudomonas aeruginosa, Enterococcus faecalis, or members of Enterobacterales grown in pure culture on blood agar or MacConkey agar.
Organism identification results must be available prior to reporting results for the Acuitas AMR Gene Panel. Antimicrobial resistance gene results are reported by the Acuitas AMR Gene Panel for the combinations of bacterial pathogens and associated genetic resistance markers indicated in Table 1 below.
The Acuitas AMR Gene Panel includes assays for the detection and reporting of genetic resistance markers associated with resistance to select drugs in the following antibiotic groups: aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, penicillins, sulfonamides, trimethoprim, and vancomycin, to aid in the identification of potentially antimicrobial-resistant organisms. The panel includes an assay for the detection of the mobilized colistin genetic determinant MCR-1, a marker of public health importance associated with reduced inhibitory activity of polymyxins.
The results of the Acuitas AMR Gene Panel for detection and identification of genetic determinants associated with antimicrobial resistance are used along with the Acuitas AMR Gene Panel Electronic User Guide (EUG). In certain cases, this information may be used as an aid to clinicians in the management of patients with known or suspected antibiotic non-susceptible or resistant bacterial infections. The EUG contains information on the appropriateness of reporting resistance markers detected by the Acuitas AMR Gene Panel for claimed organisms based on the strength of the collective, totality of scientific evidence delineating the level of association between molecular marker detection with phenotypic, clinical resistance. Test results are not conclusive or prescriptive for labeled use of any specific antimicrobial drug product, and therefore, this test cannot be used in place of or to postpone or delay phenotypic antimicrobial susceptibility testing.
A “Detected” or “Not Detected” result does not rule out the presence of other antimicrobial resistance markers not detected by the Acuitas AMR Gene Panel. A "Not Detected" result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes, as multiple mechanisms of resistance may exist.
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/K191288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191288: Acuitas AMR Gene Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191288
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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