510(k) · Cleared
ClearedBD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC 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 Aug 15, 2018 as substantially equivalent to DEN150058 (Bio-Rad Laboratories, 2016) after a 48-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Aug 15, 2018
- Review
- 48 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150058 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- This deviceK181711 BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite…Microbiologics, Inc. · 2018
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) | K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel | Microbiologics, Inc. | 2018 | — |
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 13.8 · 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…ulation: 21 CFR 866.3920 Panel: 83-Microbiology Product Code: PMN Predicate Device: Bio-Rad Amplichek II (DEN 150058) Device Description: The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are used… | 2016 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate DEN150058.
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 BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are intended for use as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica performed with the BD MAX™ Enteric Parasite Panel on the BD MAX™ System. The controls comprise cultured and…
Read the full statement (121 words)
The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are intended for use as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica performed with the BD MAX™ Enteric Parasite Panel on the BD MAX™ System. The controls comprise cultured and inactivated C. parvum, G. lamblia and recombinant Escherichia coli. The E. coli carries a plasmid which is a surrogate control material for detection of E. histolytica.
The BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day QC Panel are not intended to replace manufacturer controls provided with the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181711 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181711: BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181711
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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