510(k) · Cleared
ClearedNATtrol BD MAX Vaginal Panel External Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeptometrix · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cleared on Feb 2, 2022 as substantially equivalent to K181683 (Microbiologics, Inc., 2018) after a 615-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Feb 2, 2022
- Review
- 615 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K181683 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backK181683 BD MAX CT/GC/TV 20-Day QC PanelMicrobiologics, Inc. · 2018
- This deviceK201403 NATtrol BD MAX Vaginal Panel External ControlsZeptometrix · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K181683 | BD MAX CT/GC/TV 20-Day QC Panel | Microbiologics, Inc. | 2018 | — |
| 0 (this device) | K201403 | NATtrol BD MAX Vaginal Panel External Controls | Zeptometrix | 2022 | — |
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 |
|---|---|---|---|
| * | K181683 | BD MAX CT/GC/TV 20-Day QC PanelSummary page 4…er: 866.3920 Classification: Class II Predicate Device: Microbiologics, Inc. BD MAX CT/GC/TV 20-Day QC Panel (K181683) Substantial Equivalency Microbiologics, Inc… | 2018 |
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.
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?
NATtrolTM BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAXTM System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD…
Read the full statement (280 words)
NATtrolTM BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAXTM System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAXTM System. This product is not intended to replace manufacturer controls provided in the package insert.
NATtrolTM BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAXTM System. NATtrolTM BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAXTM System. This product is not intended to replace manufacturer controls provided in the package insert.
NATtrolTM Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAXTM System. NATtrol Candida/TV Positive Control is a qualitative control containing intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAXTM System. This product is not intended to replace manufacturer controls provided in the package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201403 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201403: NATtrol BD MAX Vaginal Panel External Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201403
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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