510(k) · Cleared
ClearedRapidec Carba NP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerieux S.A. · PTJ Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
Cleared on Apr 27, 2017 as substantially equivalent to K091766 (Binax, Inc., 2010) after a 245-day review. Its family tree reaches back 2 generations to 1985. 2 later devices descend from it.
- Decided
- Apr 27, 2017
- Review
- 245 days
- Class
- Class II
- Product code
- PTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K850291 (1985). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK850291 Mueller Hinton Agar W/4% Nacl W/AntibioticsRemel Co. · 1985 · Recalled
- 1 generation backK091766 Clearview Exact PBP2A Test, Model 891-000Binax, Inc. · 2010
- This deviceK162385 Rapidec Carba NPBiomerieux S.A. · 2017
- Descendant · cites it directly · 1 of its ownK191889 NG-Test CARBA 5Ng Biotech · 2019
- Descendant · 2 generations on · 0 of its ownK243499 NG-Test® CTX-M MULTINg Biotech · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850291 | Mueller Hinton Agar W/4% Nacl W/Antibiotics | Remel Co. | 1985 | 2 |
| −1 | K091766 | Clearview Exact PBP2A Test, Model 891-000 | Binax, Inc. | 2010 | — |
| 0 (this device) | K162385 | Rapidec Carba NP | Biomerieux S.A. | 2017 | — |
| +1 | K191889 | NG-Test CARBA 5 | Ng Biotech | 2019 | — |
| +2 | K243499 | NG-Test® CTX-M MULTI | Ng Biotech | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2025 | 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 PTJ? 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 PTJ device
- #1 K243499 NG-Test® CTX-M MULTIscore 10.3 · 4 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 |
|---|---|---|---|
| * | K091766 | Clearview Exact PBP2A Test, Model 891-000Summary page 4…ion Name: Antimicrobial Susceptibility Test Powder Product Code: PTJ Common Name: RAPIDEC® CARBA NP Predicate Device: Clearview® Exact PBP2a Test (K091766) 510(k) Summary: Intended use: RAPIDEC® CARBA NP is a phenotypic (colorimetric) in vitro diagnostic test for the qualitative d… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191889 | NG-Test CARBA 5 | 2019 | 1 |
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 32 years and passes through 3 companies; a new generation was cleared every 24.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K191889 (Ng Biotech, 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K091766.
How does its category compare?
All PTJ devicesPTJ Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PTJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PTJ
Too few PTJ 510(k)s in any year since 2007 to give a median.
Recalls per year · PTJ
No recall names PTJ since 2007.
Adverse event reports per year · PTJ
8in 2021
MAUDE reports naming product code PTJ, 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 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
RAPIDEC® CARBA NP is a phenotypic (colorimetric) in vitro diagnostic test for the qualitative detection of carbapenemase enzymes in Enterobacteriaceae and Pseudomonas aeruginosa colonies that have elevated MIC values to any carbapenem. RAPIDEC® CARBA NP is performed on pure colonies grown on non-selective sheep blood agar culture media. RAPIDEC® CARBA NP is intended as an aid in the prevention and control of infection caused by carbapenemase-producing…
Read the full statement (140 words)
RAPIDEC® CARBA NP is a phenotypic (colorimetric) in vitro diagnostic test for the qualitative detection of carbapenemase enzymes in Enterobacteriaceae and Pseudomonas aeruginosa colonies that have elevated MIC values to any carbapenem. RAPIDEC® CARBA NP is performed on pure colonies grown on non-selective sheep blood agar culture media.
RAPIDEC® CARBA NP is intended as an aid in the prevention and control of infection caused by carbapenemase-producing Enterobacteriaceae and Pseudomonas aeruginosa.
RAPIDEC® CARBA NP is not intended to guide or monitor the treatment for these bacterial infections. A negative result does not preclude the presence of carbapenemase enzymes. The ability of RAPIDEC® CARBA NP to detect carbapenemase enzymes encoded by genetic markers other than KPC, NDM, OXA-48, VIM, and IMP has not been established. RAPIDEC® CARBA NP testing should be used in conjunction with other laboratory tests including antimicrobial susceptibility testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162385: Rapidec Carba NP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162385
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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