510(k) · Cleared
ClearedMDx-Chex for BCY
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck, LLC · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cleared on Mar 17, 2026 as substantially equivalent to K212576 (Streck, Inc., 2022) after an 84-day review. Its family tree reaches back 5 generations to 2016.
- Decided
- Mar 17, 2026
- Review
- 84 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN150058 (2016). No later device cites it as a predicate yet.
- Root · 5 generations backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- 4 generations backK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
- 3 generations backK190222 FilmArray Pneumonia/Pneumoniaplus ControlMaine Molecular Quality Controls, Inc. · 2019
- 2 generations backK200010 FilmArray BCID2 Control Panel M416Maine Molecular Quality Controls, Inc. · 2020
- 1 generation backK212576 MDx-Chex for BCID2Streck, Inc. · 2022
- This deviceK254167 MDx-Chex for BCYStreck, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| −4 | K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016 | — |
| −3 | K190222 | FilmArray Pneumonia/Pneumoniaplus Control | Maine Molecular Quality Controls, Inc. | 2019 | — |
| −2 | K200010 | FilmArray BCID2 Control Panel M416 | Maine Molecular Quality Controls, Inc. | 2020 | — |
| −1 | K212576 | MDx-Chex for BCID2 | Streck, Inc. | 2022 | — |
| 0 (this device) | K254167 | MDx-Chex for BCY | Streck, LLC | 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 |
|---|---|---|---|
| * | K212576 | MDx-Chex for BCID2Summary page 5…Code: PMN Panel: Microbiology Predicate Device: MDx-Chex for BCID2 (K212576) Device Description: MDx-Chex for BCY is a quality control kit consisting of two controls for the Diasorin LIAISON-PLEX… | 2022 |
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 5 ancestors has a recall.
- 2 other devices also cite its predicate K212576.
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 BCY is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast by the Diasorin LIAISON PLEX Yeast Blood Culture assay on the LIAISON PLEX System. The MDx-Chex for BCY Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Yeast: Candida…
Read the full statement (115 words)
MDx-Chex for BCY is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast by the Diasorin LIAISON PLEX Yeast Blood Culture assay on the LIAISON PLEX System. The MDx-Chex for BCY Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Yeast: Candida albicans, Candida dubliniensis, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Candida auris, Candida kefyr, Candida lipolytica, Candida lusitaniae, Candida guilliermondii, Cryptococcus neoformans/gattii, Candida famata, Candida haemulonii/duobushamulonii. Negative Control: buffered solution only. 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/K254167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254167: MDx-Chex for BCY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254167
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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