510(k) · Cleared
ClearedRPS Adeno Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rapid Pathogen Screening · GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33
Cleared on Nov 22, 2005 as substantially equivalent to K990630 (Sa Scientific, Inc., 1999) after a 112-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Nov 22, 2005
- Review
- 112 days
- Class
- Class I
- Product code
- GOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990630 (1999). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K110722RPS Adeno Detector PlusRapid Pathogen Screening, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990630 | Sas Adeno Test | Sa Scientific, Inc. | 1999 | — |
| 0 (this device) | K052092 | RPS Adeno Detector | Rapid Pathogen Screening | 2005 | — |
| +1 | K110722 | RPS Adeno Detector Plus | Rapid Pathogen Screening, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
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 GOD? 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 |
|---|---|---|---|
| * | K990630 | Sas Adeno TestSummary page 1…: RPS Adeno Detector Predicate Devices: SA Scientific, Inc. SAS Adeno Test K990630 Device Classification: Adenovirus serological reagents are devices that consist of an… | 1999 |
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 |
|---|---|---|---|
| K110722 | RPS Adeno Detector Plus | 2011 | 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?
- Its one ancestor has no recall.
- Of its descendants, K110722 (Rapid Pathogen Screening, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GOD devicesGOD Antigens, Cf (Including Cf Control), Adenovirus 1-33: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GOD
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · GOD
Too few GOD 510(k)s in any year since 2007 to give a median.
Recalls per year · GOD
No recall names GOD since 2007.
Adverse event reports per year · GOD
No MAUDE report names GOD 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 | 1 | — | 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 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RPS Adeno Detector is a rapid immunochromatography test for visual, qualitative in-vitro detection of adenoviral antigens (hexon protein) directly from human eye fluid. The test is intended for use as an aid in the rapid differential diagnosis of acute adenoviral conjunctivitis. All negative test results should be confirmed by cell culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052092: RPS Adeno Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052092
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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