510(k) · Cleared
ClearedCepheid Xpert Respiratory Control Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microbiologics, Inc. · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cleared on Oct 7, 2019 as substantially equivalent to K182472 (Microbiologics, Inc., 2018) after a 263-day review. Its family tree reaches back 2 generations to 2016.
- Decided
- Oct 7, 2019
- Review
- 263 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150058 (2016). No later device cites it as a predicate yet.
- Root · 2 generations backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- 1 generation backK182472 Cepheid Xpert GBS LB Control PanelMicrobiologics, Inc. · 2018
- This deviceK190086 Cepheid Xpert Respiratory Control PanelMicrobiologics, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| −1 | K182472 | Cepheid Xpert GBS LB Control Panel | Microbiologics, Inc. | 2018 | — |
| 0 (this device) | K190086 | Cepheid Xpert Respiratory Control Panel | Microbiologics, Inc. | 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 PMN? 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 PMN device
- #1 K251526 FilmArray GI Control Panel M238score 13.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K182472 | Cepheid Xpert GBS LB Control PanelSummary page 3…21 CFR 866.3920 Panel: 83-Microbiology Product Code: PMN Predicate Device: Cepheid Xpert® GBS LB Control Panel (K182472) Device Description: The Cepheid Xpert® Respiratory Control Panel is used to monitor RNA extraction, amplification and det… | 2018 |
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 3 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K182472.
How does its category compare?
All PMN devicesPMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PMN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PMN
90in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PMN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PMN
1in 2023
MAUDE reports naming product code PMN, 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 | 3 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 59 | 0 | 0 |
| 2019 | 6 | 71 | 1 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 3 | 582 | 0 | 0 |
| 2023 | 4 | 90 | 0 | 1 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 85 | 0 | — |
What is it indicated for?
The Cepheid Xpert® Respiratory Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A performed with the Cepheid Xpert® Xpress Flu/RSV assay on the GeneXpert® Instrument System. The controls comprise…
Read the full statement (116 words)
The Cepheid Xpert® Respiratory Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A performed with the Cepheid Xpert® Xpress Flu/RSV assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A as the positive control and Coxsackie virus B1 as the negative control.
The Cepheid Xpert® Respiratory Control Panel is not intended to replace manufacturer controls provided with the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190086: Cepheid Xpert Respiratory Control Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190086
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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