De Novo · Granted
GrantedSimple 2 Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) · QYA System For Detection Of Nucleic Acid From Non-Viral Microorganism (S) Causing Stis Using Specimens Collected At Home
Granted on Nov 15, 2023 as a new device type through De Novo after a 1,094-day review. 1 later device descends from it.
- Decided
- Nov 15, 2023
- Review
- 1,094 days
- Class
- Class II
- Product code
- QYA
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN200070 Simple 2 TestLetsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) · 2023
- Descendant · cites it directly · 0 of its ownK243410 simpli-COLLECT STI TestAbbott Molecular · 2025
Most influential descendants
Showing 1 of 1 · See all- K243410simpli-COLLECT STI TestAbbott Molecular · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200070 | Simple 2 Test | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) | 2023 | — |
| +1 | K243410 | simpli-COLLECT STI Test | Abbott Molecular | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA De Novo 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.
Top candidate predicates for a new QYA device
- #1 K243410 simpli-COLLECT STI Testscore 8.8 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243410 | simpli-COLLECT STI Test | 2025 | 0 |
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?
- Of its descendants, K243410 (Abbott Molecular, 2025) has gone furthest, with 0 descendants of its own.
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. 2023, 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 Simple 2 Test is intended for in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home-collected specimens which are shipped to a clinical laboratory for testing using the Aptima Combo 2 Assay on the Panther System. This product is available over-the-counter (OTC) to consumers 18 years of age and older. The Simple 2 Test contains all the necessary components to collect urine from male patients…
Read the full statement (187 words)
The Simple 2 Test is intended for in vitro detection and identification of Chlamydia trachomatis (CT)
and/or Neisseria gonorrhoeae (GC) in home-collected specimens which are shipped to a clinical
laboratory for testing using the Aptima Combo 2 Assay on the Panther System. This product is
available over-the-counter (OTC) to consumers 18 years of age and older.
The Simple 2 Test contains all the necessary components to collect urine from male patients (Simple
2 Urine Home Collection Kit (Penile)) or vaginal swabs from female patients (Simple 2 Swab Home
Collection Kit (Vaginal)) in their home, or in similar environments, without supervision from a
healthcare provider.
The Simple 2 Test Collection Kits may also be used to self-collect specimens in a clinic.
The testing is performed, as determined to be appropriate, based on the results of LetsGetChecked
Suitability Questionnaire.
This test system is not a substitute for visits to a healthcare provider. The information provided by
this product should not be used to start, stop, or change any course of treatment unless advised by
your healthcare provider.
Testing is limited to the manufacturer, Priva Path laboratories (d.b.a. LetsGetChecked, Inc.).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200070 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN200070: Simple 2 Test.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN200070
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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