510(k) · Cleared
ClearedCepheid Xpert GBS LB 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 Nov 8, 2018 as substantially equivalent to DEN150058 (Bio-Rad Laboratories, 2016) after a 59-day review. Its family tree reaches back 1 generation to 2016. 4 later devices descend from it.
- Decided
- Nov 8, 2018
- Review
- 59 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150058 (2016). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- This deviceK182472 Cepheid Xpert GBS LB Control PanelMicrobiologics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK190086 Cepheid Xpert Respiratory Control PanelMicrobiologics, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK191168 Cepheid Xpert SA Nasal Complete Control PanelMicrobiologics, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK191172 Cepheid Xpert MRSA NxG Control PanelMicrobiologics, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK190223 Cepheid Xpert CT/NG Control PanelMicrobiologics, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K190086Cepheid Xpert Respiratory Control PanelMicrobiologics, Inc. · 2019 · cites it directly0descendants
- K191168Cepheid Xpert SA Nasal Complete Control PanelMicrobiologics, Inc. · 2019 · cites it directly0descendants
- K191172Cepheid Xpert MRSA NxG Control PanelMicrobiologics, Inc. · 2019 · cites it directly0descendants
- K190223Cepheid Xpert CT/NG Control PanelMicrobiologics, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| 0 (this device) | K182472 | Cepheid Xpert GBS LB Control Panel | Microbiologics, Inc. | 2018 | — |
| +1 | K190086 | Cepheid Xpert Respiratory Control Panel | Microbiologics, Inc. | 2019 | — |
| +1 | K191168 | Cepheid Xpert SA Nasal Complete Control Panel | Microbiologics, Inc. | 2019 | — |
| +1 | K191172 | Cepheid Xpert MRSA NxG Control Panel | Microbiologics, Inc. | 2019 | — |
| +1 | K190223 | Cepheid Xpert CT/NG Control Panel | Microbiologics, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 4 | 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 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 |
|---|---|---|---|
| * | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and…Summary page 4…n: 21 CFR 866.3920 Panel: 83-Microbiology Product Code: PMN Predicate Device: Bio-Rad Amplichek II (DEN 150058) Device Description: The Cepheid Xpert® GBS LB Control Panel is used to monitor the extraction, amplification and detecti… | 2016 |
What descends from it? (4)
4 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?
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. 2018, 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® GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert® GBS LB Assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control.
The Cepheid Xpert® GBS LB 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/K182472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182472: Cepheid Xpert GBS LB 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/K182472
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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