510(k) · Cleared
ClearedMDx-Chex for BCID2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck, Inc. · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cleared on Jan 19, 2022 as substantially equivalent to K200010 (Maine Molecular Quality Controls, Inc., 2020) after a 156-day review. Its family tree reaches back 4 generations to 2016. 5 later devices descend from it.
- Decided
- Jan 19, 2022
- Review
- 156 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN150058 (2016). 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- 3 generations backK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
- 2 generations backK190222 FilmArray Pneumonia/Pneumoniaplus ControlMaine Molecular Quality Controls, Inc. · 2019
- 1 generation backK200010 FilmArray BCID2 Control Panel M416Maine Molecular Quality Controls, Inc. · 2020
- This deviceK212576 MDx-Chex for BCID2Streck, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK231221 MDx-Chex for BC-GPStreck · 2023
- Descendant · cites it directly · 1 of its ownK231223 MDx-Chex for BC-GNStreck · 2023
- Descendant · 2 generations on · 0 of its ownK260041 MDx-Chex for BCPStreck, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK254166 MDx-Chex for BCNStreck · 2026
- Descendant · cites it directly · 0 of its ownK254167 MDx-Chex for BCYStreck, LLC · 2026
Most influential descendants
Showing 5 of 5 · See all- K231221MDx-Chex for BC-GPStreck · 2023 · cites it directly1descendant
- K231223MDx-Chex for BC-GNStreck · 2023 · cites it directly1descendant
- K260041MDx-Chex for BCPStreck, LLC · 2026 · 2 generations on0descendants
- K254166MDx-Chex for BCNStreck · 2026 · 2 generations on0descendants
- K254167MDx-Chex for BCYStreck, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| −3 | 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 | — |
| −1 | K200010 | FilmArray BCID2 Control Panel M416 | Maine Molecular Quality Controls, Inc. | 2020 | — |
| 0 (this device) | K212576 | MDx-Chex for BCID2 | Streck, Inc. | 2022 | — |
| +1 | K231221 | MDx-Chex for BC-GP | Streck | 2023 | — |
| +1 | K231223 | MDx-Chex for BC-GN | Streck | 2023 | — |
| +2 | K260041 | MDx-Chex for BCP | Streck, LLC | 2026 | — |
| +2 | K254166 | MDx-Chex for BCN | Streck | 2026 | — |
| +1 | K254167 | MDx-Chex for BCY | Streck, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K200010 | FilmArray BCID2 Control Panel M416Summary page 4…assays Product Code: PMN (866.3920) Panel Microbiology Predicate Device: K200010-Maine Molecular FilmArray BCID2 Control Panel M416 Device Description MDx-Chex for BCID2 Control 1 - GN is positive for certain… | 2020 |
What descends from it? (5)
3 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. 2022, 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?
MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast, Gram positive and Gram negative bacteria, as well as associated antimicrobial resistance genes, by the BioFire FilmArray Blood Culture Identification 2 (BCID2) Panel on FilmArray systems. Control 1 - GN: Gram negative bacteria: Acinetobacter colcoaceticus-baumannii complex, Bacteroides fragilis…
Read the full statement (160 words)
MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast, Gram positive and Gram negative bacteria, as well as associated antimicrobial resistance genes, by the BioFire FilmArray Blood Culture Identification 2 (BCID2) Panel on FilmArray systems. Control 1 - GN: Gram negative bacteria: Acinetobacter colcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenza, Neisseria meningitides, Pseudomonas aeruginosa, Stenotrophomonas maltophilia; antimicrobial resistance genes: KPC, CTX-M, IMP, NDM, OXA-48-like, VIM, mcr- 1. Control 2 - GPY: Gram positive bacteria: Enterococcus Jaecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunesis, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes; yeast: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Cryptococcus neoformans/gatti; antimicrobial resistance genes mecA/C and MREJ, vanA/B. This product is not intended to replace manufacturer controls provided with the device.
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/K212576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212576: MDx-Chex for BCID2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212576
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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