510(k) · Cleared
Clearedsimpli-COLLECT STI Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular · QYA System For Detection Of Nucleic Acid From Non-Viral Microorganism (S) Causing Stis Using Specimens Collected At Home
Cleared on Jan 30, 2025 as substantially equivalent to DEN200070 (Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.), 2023) after a 90-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Jan 30, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- QYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200070 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200070 Simple 2 TestLetsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) · 2023
- This deviceK243410 simpli-COLLECT STI TestAbbott Molecular · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200070 | Simple 2 Test | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) | 2023 | — |
| 0 (this device) | K243410 | simpli-COLLECT STI Test | Abbott Molecular | 2025 | — |
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 QYA? 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.
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 QYA devicesQYA System For Detection Of Nucleic Acid From Non-Viral Microorganism (S) Causing Stis Using Specimens Collected At Home: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QYA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QYA
Too few QYA 510(k)s in any year since 2007 to give a median.
Recalls per year · QYA
No recall names QYA since 2007.
Adverse event reports per year · QYA
No MAUDE report names QYA 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 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens. The specimens are shipped to a clinical laboratory for testing using the Alinity m STI Assay with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from CT…
Read the full statement (201 words)
The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens. The specimens are shipped to a clinical laboratory for testing using the Alinity m STI Assay with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from CT, DNA from NG, ribosomal RNA from TV, and ribosomal RNA from MG, to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following self-collected specimens from symptomatic and asymptomatic individuals for the following analytes:
• CT: vaginal swabs, female urine and male urine
• NG: vaginal swabs, female urine, and male urine
• TV: vaginal swabs, female urine and male urine
• MG: vaginal swabs and male urine
The simpli-COLLECT STI Test contains all the necessary components for the self-collection and transport of urine from male and female patients (simpli-COLLECT Urine Collection Kit) or vaginal swabs from female patients (simpli-COLLECT Swab Collection Kit) in their home, or in similar environments. The simpli-COLLECT Collection Kits may also be used to self-collect specimens in a clinic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243410: simpli-COLLECT STI Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243410
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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