510(k) · Cleared
ClearedModification to Biostar Oia Shigatox
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iverness Medical Professional Diagnostics · GNA Antisera, All Types, Escherichia Coli
Cleared on Oct 2, 2007 as substantially equivalent to K061889 (Inverness Medical-Biostar, Inc., 2006) after a 92-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Oct 2, 2007
- Review
- 92 days
- Class
- Class I
- Product code
- GNA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953362 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953362 | Premier Ehec | Meridian Diagnostics, Inc. | 1995 | 2 |
| −1 | K061889 | Biostar Oia Shigatox | Inverness Medical-Biostar, Inc. | 2006 | 1 |
| 0 (this device) | K071799 | Modification to Biostar Oia Shigatox | Iverness Medical Professional Diagnostics | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
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 GNA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K061889 | Biostar Oia ShigatoxSummary page 1…Panel: 83 Microbiology C. Identification of legally marketed device to which we are claiming equivalence [§807.92(a)(3)]: BioStar OIA SHIGATOX; K061889; Inverness Medical-BioStar Inc. INVERNESS MEDICAL-BIOSTAR INC. REVISION 8/21/2007 OIA SHIGATOX… | 2006 |
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 12 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
- 3 of the 3 ancestors have a recall of any class.
How does its category compare?
All GNA devicesGNA Antisera, All Types, Escherichia Coli: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GNA
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GNA
Too few GNA 510(k)s in any year since 2007 to give a median.
Recalls per year · GNA
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GNA
No MAUDE report names GNA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 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 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioStar® OIA® SHIGATOX assay is an Optical Immunoassay (OIA) test for the qualitative, rapid detection of the presence of Shiga Toxins in human diarrheal fecal specimens, broth cultures, fecal specimens in Cary Blair Transport Media, or swab sampling of colonies from a culture plate. This test is intended for in vitro diagnostic use as an aid in the diagnosis of infection by Shiga Toxin-producing Escherichia coli (STEC) both 0157 and all non - 0157 Shiga toxin producing strains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071799: Modification to Biostar Oia Shigatox.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071799
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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