510(k) · Cleared
ClearedMDx-Chex for BCN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cleared on Mar 23, 2026 as substantially equivalent to K231223 (Streck, 2023) after a 90-day review. Its family tree reaches back 6 generations to 2016.
- Decided
- Mar 23, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN150058 (2016). No later device cites it as a predicate yet.
- Root · 6 generations backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- 5 generations backK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
- 4 generations backK190222 FilmArray Pneumonia/Pneumoniaplus ControlMaine Molecular Quality Controls, Inc. · 2019
- 3 generations backK200010 FilmArray BCID2 Control Panel M416Maine Molecular Quality Controls, Inc. · 2020
- 2 generations backK212576 MDx-Chex for BCID2Streck, Inc. · 2022
- 1 generation backK231223 MDx-Chex for BC-GNStreck · 2023
- This deviceK254166 MDx-Chex for BCNStreck · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| −5 | K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016 | — |
| −4 | 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 | K212576 | MDx-Chex for BCID2 | Streck, Inc. | 2022 | — |
| −1 | K231223 | MDx-Chex for BC-GN | Streck | 2023 | — |
| 0 (this device) | K254166 | MDx-Chex for BCN | Streck | 2026 | — |
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 |
|---|---|---|---|
| * | K231223 | MDx-Chex for BC-GNSummary page 5…duct Code: PMN (21CFR 866.3920) Panel: Microbiology Predicate Device: K231223 - MDx-Chex for BC-GN Device Description MDx-Chex® for BCN is a quality control kit consisting of two controls for the Diasor… | 2023 |
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 10 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 6 ancestors has a recall.
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. 2026, 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 BCN is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-negative bacteria and associated antimicrobial resistance genes, by the Diasorin LIAISON PLEX Gram-Negative Blood Culture assay on the LIAISON PLEX System. MDx-Chex for BCN Control 1 and Control 2 are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood…
Read the full statement (146 words)
MDx-Chex for BCN is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-negative bacteria and associated antimicrobial resistance genes, by the Diasorin LIAISON PLEX Gram-Negative Blood Culture assay on the LIAISON PLEX System. MDx-Chex for BCN Control 1 and Control 2 are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Control 1: Gram-negative bacteria: Acinetobacter baumannii, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa, Stenotrophomonas maltophilia; genus: Acinetobacter spp., Pseudomonas spp.; antimicrobial resistance genes: KPC, NDM, and VIM. Control 2: Gram-negative bacteria: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella variicola, Morganella morganii, Serratia marcescens; family/genus: Enterobacteriaceae/Morganellaceae, Citrobacter spp., Enterobacter spp., Proteus spp., Salmonella spp.; antimicrobial resistance genes: CTX-M, IMP, MCR, OXA, and SME. This product is not intended to replace manufacturer controls provided with the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254166: MDx-Chex for BCN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254166
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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