De Novo · Granted
GrantedAmplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Granted on Mar 28, 2016 as a new device type through De Novo after a 103-day review. 33 later devices descend from it.
- Decided
- Mar 28, 2016
- Review
- 103 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
33 later devices descend from it, 4 citing it directly.
- This deviceDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- Descendant · cites it directly · 25 of its ownK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
- Descendant · 2 generations on · 8 of its ownK190222 FilmArray Pneumonia/Pneumoniaplus ControlMaine Molecular Quality Controls, Inc. · 2019
- Descendant · 3 generations on · 7 of its ownK200010 FilmArray BCID2 Control Panel M416Maine Molecular Quality Controls, Inc. · 2020
- Descendant · 2 generations on · 7 of its ownK173171 FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. · 2017
- Descendant · 2 generations on · 7 of its ownK163522 FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. · 2017
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K161573FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016 · cites it directly25descendants
- K190222FilmArray Pneumonia/Pneumoniaplus ControlMaine Molecular Quality Controls, Inc. · 2019 · 2 generations on8descendants
- K200010FilmArray BCID2 Control Panel M416Maine Molecular Quality Controls, Inc. · 2020 · 3 generations on7descendants
- K173171FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. · 2017 · 2 generations on7descendants
- K163522FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. · 2017 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| +1 | K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016 | — |
| +2 | K190222 | FilmArray Pneumonia/Pneumoniaplus Control | Maine Molecular Quality Controls, Inc. | 2019 | — |
| +3 | K200010 | FilmArray BCID2 Control Panel M416 | Maine Molecular Quality Controls, Inc. | 2020 | — |
| +2 | K173171 | FilmArray RP2/RP2plus Control Panel | Maine Molecular Quality Controls, Inc. | 2017 | — |
| +2 | K163522 | FilmArray Warrior Control Panel M290 | Maine Molecular Quality Controls, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 7 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (33)
See all 334 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161573 | FilmArray RP EZ Control Panel M265 | 2016 | 25 |
| K182472 | Cepheid Xpert GBS LB Control Panel | 2018 | 4 |
| K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel | 2018 | 0 |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level… | 2016 | 0 |
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?
- Of its descendants, K161573 (Maine Molecular Quality Controls, Inc., 2016) has gone furthest, with 25 descendants of its own.
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. 2016, 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?
Amplichek II is intended for use as an external assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. This product is only for use with assays and instruments listed in the Representative Results Chart in this labeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150058 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN150058: Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN150058
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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