510(k) · Cleared
ClearedPanNAT STEC Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micronics, Inc. · PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
Cleared on Jun 1, 2018 as substantially equivalent to K140111 (Becton, Dickinson and Company, 2014) after a 221-day review. Its family tree reaches back 3 generations to 2013.
- Decided
- Jun 1, 2018
- Review
- 221 days
- Class
- Class II
- Product code
- PCI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN130003 (2013). No later device cites it as a predicate yet.
- Root · 3 generations backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 2 generations backK123274 Progastro SSCS AssayGen-Probe Prodesse, Inc. · 2013
- 1 generation backK140111 BD Max (TM) Enteric Bacterial Panel;BD Max (TM) InstrumentBecton, Dickinson and Company · 2014 · Recalled
- This deviceK173330 PanNAT STEC TestMicronics, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −2 | K123274 | Progastro SSCS Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
| −1 | K140111 | BD Max (TM) Enteric Bacterial Panel;BD Max (TM) Instrument | Becton, Dickinson and Company | 2014 | 2 |
| 0 (this device) | K173330 | PanNAT STEC Test | Micronics, 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 PCI? 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 PCI device
- #1 K250358 BD Enteric Bacterial Panel for BD COR System…score 11.8 · 6 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K140111 | BD Max (TM) Enteric Bacterial Panel;BD Max (TM) InstrumentSummary page 4…: 866.3990, Gastrointestinal microorganism multiplex nucleic acid- based assay Product Code: PCI, PCH, OOI Class: 2 5.3 Predicate Device BD Max Enteric Bacterial Panel (K140111) 5.4 Intended Use The Micronics PanNAT STEC Test is a qualitative, in vitro nucleic acid amplification- based test intended for… | 2014 |
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 5 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K140111.
How does its category compare?
All PCI devicesPCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PCI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PCI
Too few PCI 510(k)s in any year since 2007 to give a median.
Recalls per year · PCI
No recall names PCI since 2007.
Adverse event reports per year · PCI
7in 2025
MAUDE reports naming product code PCI, 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 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 1 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Micronics PanNAT STEC Test is a qualitative, in vitro nucleic acid amplification-based test intended for the simultaneous detection and identification of the stx1 and stx2 Shiga toxin genes and the O-antigen gene cluster of E.coli O157 (fcl). Testing is performed in a unitized cartridge on the PanNAT System on soft to diarrheal unpreserved or Cary-Blair preserved stool specimens from individuals with signs and symptoms of gastrointestinal infection.…
Read the full statement (204 words)
The Micronics PanNAT STEC Test is a qualitative, in vitro nucleic acid amplification-based test intended for the simultaneous detection and identification of the stx1 and stx2 Shiga toxin genes and the O-antigen gene cluster of E.coli O157 (fcl). Testing is performed in a unitized cartridge on the PanNAT System on soft to diarrheal unpreserved or Cary-Blair preserved stool specimens from individuals with signs and symptoms of gastrointestinal infection. The PanNAT STEC Test is intended for use, in conjunction with clinical presentation, laboratory findings and epidemiological risk factors, as an aid in detection of specific Shiga-toxin expressing strains of E. coli ("STEC") from patients with diarrhea.
The results of this test should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Positive PanNAT STEC Test results do not rule out the potential for coinfection with other pathogens that are not detected by this device and may not be indicative of the sole or definitive cause of patient illness. Negative PanNAT STEC Test results in the context of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn’s disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173330: PanNAT STEC Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173330
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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