510(k) · Cleared
ClearedGenzyme Osom Trichomonas Rapid Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Corp. · JWZ Kit, Screening, Trichomonas
Cleared on Apr 2, 2004 as substantially equivalent to K020226 (Hellen Professional Services, 2002) after a 112-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Apr 2, 2004
- Review
- 112 days
- Class
- Class I
- Product code
- JWZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020226 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK020226 Xenostrip-TV Trichomonas Diagnostic Test Kit; Catalog Numbers…Hellen Professional Services · 2002
- This deviceK033864 Genzyme Osom Trichomonas Rapid TestGenzyme Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020226 | Xenostrip-TV Trichomonas Diagnostic Test Kit; Catalog Numbers S1383.01… | Hellen Professional Services | 2002 | — |
| 0 (this device) | K033864 | Genzyme Osom Trichomonas Rapid Test | Genzyme Corp. | 2004 | — |
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 JWZ? 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 |
|---|---|---|---|
| * | K020226 | Xenostrip-TV Trichomonas Diagnostic Test Kit; Catalog Numbers S1383.01, S1383.02 &…Summary page 1…Microorganism differentiation and identification device 6. Legally Marketed Devices to which Equivalence is Being Claimed: Xenotope XenoStrip®-Tv Test (K 020226) 7. Device Description Intended Use… | 2002 |
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 JWZ devicesJWZ Kit, Screening, Trichomonas: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWZ
FDA has decided no JWZ device since 2007.
Median 510(k) review, days · JWZ
Too few JWZ 510(k)s in any year since 2007 to give a median.
Recalls per year · JWZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWZ
No MAUDE report names JWZ since 2007.
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 | — | 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 | — | 0 | 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 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OSOM® Trichomonas Rapid Test is intended for the
qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal
swabs and from the saline solution prepared when making wet mounts from vaginal
swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or
suspected exposure to the Trichomonas pathogen. This device is intended for use in
physicians' offices as well as clinical laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033864 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033864: Genzyme Osom Trichomonas Rapid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033864
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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