510(k) · Cleared
Recalled · 2002Prospect Shiga Toxin Microplate Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alexon - Trend, Inc. · GMZ Antigens, All Types, Escherichia Coli
Cleared on Apr 23, 1998 after a 72-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it. It has been recalled once.
- Decided
- Apr 23, 1998
- Review
- 72 days
- Class
- Class I
- Product code
- GMZ
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK980507 Prospect Shiga Toxin Microplate AssayAlexon - Trend, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK121364 Shiga Toxin Quik ChekTechlab Inc., Corporate Research Center · 2012
- Descendant · cites it directly · 1 of its ownK061889 Biostar Oia ShigatoxInverness Medical-Biostar, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK222829 Curian® Shiga ToxinMeridian Bioscience, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK121411 Shiga Toxin ChekTechlab Inc., Corporate Research Center · 2012
- Descendant · 2 generations on · 0 of its ownK071799 Modification to Biostar Oia ShigatoxIverness Medical Professional Diagnostics · 2007
Most influential descendants
Showing 5 of 5 · See all- K121364Shiga Toxin Quik ChekTechlab Inc., Corporate Research Center · 2012 · cites it directly1descendant
- K061889Biostar Oia ShigatoxInverness Medical-Biostar, Inc. · 2006 · cites it directly1descendant
- K222829Curian® Shiga ToxinMeridian Bioscience, Inc. · 2023 · 2 generations on0descendants
- K121411Shiga Toxin ChekTechlab Inc., Corporate Research Center · 2012 · cites it directly0descendants
- K071799Modification to Biostar Oia ShigatoxIverness Medical Professional Diagnostics · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980507 | Prospect Shiga Toxin Microplate Assay | Alexon - Trend, Inc. | 1998 | — |
| +1 | K121364 | Shiga Toxin Quik Chek | Techlab Inc., Corporate Research Center | 2012 | — |
| +1 | K061889 | Biostar Oia Shigatox | Inverness Medical-Biostar, Inc. | 2006 | 1 |
| +2 | K222829 | Curian® Shiga Toxin | Meridian Bioscience, Inc. | 2023 | — |
| +1 | K121411 | Shiga Toxin Chek | Techlab Inc., Corporate Research Center | 2012 | — |
| +2 | K071799 | Modification to Biostar Oia Shigatox | Iverness Medical Professional Diagnostics | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2002 | Not classified | Z-1373-04 | Other | A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121364 (Techlab Inc., Corporate Research Center, 2012) has gone furthest, with 1 descendant of its own.
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 ProSpecT® Shiga Toxin Microplate Assay is an in vitro microwell EIA for the qualitative detection of Shiga Toxins (Stx 1 and Stx 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures. ProSpecT® Shiga Toxin Microplate Assay is intended for use as an aid in the diagnosis of enterohemorrhagic E.coli ( EHEC) infections.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980507 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980507: Prospect Shiga Toxin Microplate Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980507
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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