510(k) · Cleared
ClearedIN-Vitro Diagnostic Vaginitis Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameritek Research, LLC · JTO Discs, Strips And Reagents, Microorganism Differentiation
Cleared on Sep 1, 2005 after a 202-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 1, 2005
- Review
- 202 days
- Class
- Class I
- Product code
- JTO
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 JTO? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All JTO devicesJTO Discs, Strips And Reagents, Microorganism Differentiation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JTO
FDA has decided no JTO device since 2007.
Median 510(k) review, days · JTO
Too few JTO 510(k)s in any year since 2007 to give a median.
Recalls per year · JTO
12in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JTO
2in 2025
MAUDE reports naming product code JTO, 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 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 2 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 0 | — | 0 | 44 |
| 2017 | 0 | — | 0 | 42 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 1 | 10 |
| 2022 | 0 | — | 12 | 4 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
FemLab is a biochemical assay intended for use as a screening test for nitrites, blood, protein, leukocytes, and proline-iminopeptidase in vaginal fluid samples, and also to measure vaginal fluid pH. It is indicated for use as an aid in the presumptive diagnosis of vaginitis or urethritis and should be used in conjunction with other laboratory tests such as Gram stain, microscopic examination, culture and KOH test. The FemLab Vaginitis Test Kit is for professional and laboratory use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050352 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050352: IN-Vitro Diagnostic Vaginitis Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050352
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026