510(k) · Cleared
ClearedStreptolex-Stat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unipath, Ltd. · GTZ Antisera, All Groups, Streptococcus Spp.
Cleared on Dec 16, 1996 as substantially equivalent to K854929 (Oxoid U.S.A., Inc., 1986) after a 187-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Dec 16, 1996
- Review
- 187 days
- Class
- Class I
- Product code
- GTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854929 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK854929 Oxoid Streptococal Grouping KitOxoid U.S.A., Inc. · 1986
- This deviceK962296 Streptolex-StatUnipath, Ltd. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854929 | Oxoid Streptococal Grouping Kit | Oxoid U.S.A., Inc. | 1986 | — |
| 0 (this device) | K962296 | Streptolex-Stat | Unipath, Ltd. | 1996 | — |
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 GTZ? 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? (3)
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 |
|---|---|---|---|
| * | K854929 | Oxoid Streptococal Grouping KitSummary page 2…method, but performance of the Unipath STREPTOLEX- STAT™ was compared to this substantially equivalent product for the qualitative grouping of streptococcal organisms. ( K854929), and is currently being marketed by Unipath (Orion Diagnostica, Inc.) 14 510k Submission K962296 Requested Revi… | 1986 |
| * | — | Streptex and Streptex - Acid Extraction Kit Named without a submission number | |
| * | — | PathoDx® Strep Grouping Named without a submission number |
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 GTZ devicesGTZ Antisera, All Groups, Streptococcus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GTZ
FDA has decided no GTZ device since 2007.
Median 510(k) review, days · GTZ
Too few GTZ 510(k)s in any year since 2007 to give a median.
Recalls per year · GTZ
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GTZ
10in 2025
MAUDE reports naming product code GTZ, 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 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
STREPTOLEX-STAT™ is substantially equivalent to several commercially available products utilizing similar methodology for the identification of streptococcal groups A, B, C,F and G.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962296: Streptolex-Stat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962296
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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