510(k) · Cleared
Recalled · Class II · 2016Biostar Oia Shigatox
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inverness Medical-Biostar, Inc. · GMZ Antigens, All Types, Escherichia Coli
Cleared on Dec 12, 2006 as substantially equivalent to K953362 (Meridian Diagnostics, Inc., 1995) and 1 other predicate after a 162-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 12, 2006
- Review
- 162 days
- Class
- Class I
- Product code
- GMZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K953362 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK953362 Premier EhecMeridian Diagnostics, Inc. · 1995 · Recalled
- This deviceK061889 Biostar Oia ShigatoxInverness Medical-Biostar, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK071799 Modification to Biostar Oia ShigatoxIverness Medical Professional Diagnostics · 2007
Most influential descendants
Showing 1 of 1 · See all- K071799Modification to Biostar Oia ShigatoxIverness Medical Professional Diagnostics · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953362 | Premier Ehec | Meridian Diagnostics, Inc. | 1995 | 2 |
| 0 (this device) | K061889 | Biostar Oia Shigatox | Inverness Medical-Biostar, Inc. | 2006 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 GMZ? 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 GMZ device
- #1 K222829 Curian® Shiga Toxinscore 5.8 · 3 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K953362 | Premier EhecSummary page 1…claiming equivalence [§807.92(a)(3)]: Predicate Device Namne(s); K Numbers; Manufacturers i. Premier EHIEC; K953362; Meridian Diagnostics, Inc. ii. ProSpecT® Shiga Toxin Microplate Assay; K980507; Alexon - Trend, Inc. INV… | 1995 |
| * | K980507 | Prospect Shiga Toxin Microplate AssaySummary page 1…K Numbers; Manufacturers i. Premier EHIEC; K953362; Meridian Diagnostics, Inc. ii. ProSpecT® Shiga Toxin Microplate Assay; K980507; Alexon - Trend, Inc. INVERNESS MEDICAL - BIOSTAR INC. REVISION 12/6/2006 CIA SHIGATOX… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071799 | Modification to Biostar Oia Shigatox | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2016 | Class II | Z-0965-2017 | Nonconforming Material/Component | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GMZ devicesGMZ Antigens, All Types, Escherichia Coli: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GMZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GMZ
Too few GMZ 510(k)s in any year since 2007 to give a median.
Recalls per year · GMZ
No recall names GMZ since 2007.
Adverse event reports per year · GMZ
1in 2017
MAUDE reports naming product code GMZ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 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, and 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/K061889 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061889: 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/K061889
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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