510(k) · Cleared

Cleared

RPS Adeno Detector Plus

K110722510(k) TraditionalCleared May 17, 201163-day reviewClass I21 CFR 866.3020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Rapid Pathogen Screening, Inc. · GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33

Cleared on May 17, 2011 as substantially equivalent to K052092 (Rapid Pathogen Screening, 2005) after a 63-day review. Its family tree reaches back 2 generations to 1999.

Decided: May 17, 2011
Review: 63 days
Class: Class I
Product code: GOD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K990630 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK990630 Sas Adeno TestSa Scientific, Inc. · 1999
1 generation backK052092 RPS Adeno DetectorRapid Pathogen Screening · 2005
This deviceK110722 RPS Adeno Detector PlusRapid Pathogen Screening, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K990630	Sas Adeno Test	Sa Scientific, Inc.	1999	—
−1	K052092	RPS Adeno Detector	Rapid Pathogen Screening	2005	—
0 (this device)	K110722	RPS Adeno Detector Plus	Rapid Pathogen Screening, Inc.	2011	—

FIG. 1 — Lineage of K110722, 1999–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K052092	RPS Adeno Detector Summary page 1 …Serological Reagents [Antigens, Cf (including control) 5.4 Predicate Device Rapid Pathogen Screening, Inc.; RPS Adeno Detector (K052092) 5.5 Device Description Components- The RPS Adeno Detector Plus TM consists of three (3) parts: a Sample Co…	Rapid Pathogen Screening	2005	—

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?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All GOD devices

GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · GOD

1in 2011

2007high 1 (2011) · low 0 (2007)2026

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The RPS Adeno Detector Plus is a rapid immunoassay test for the 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

conjunctivitis.

Negative results do not preclude Adenovirus infection nor are they intended to rule

out other microbial-caused infections of the conjunctiva, and should not be used as

the sole basis for treatment or other management decisions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110722 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110722: RPS Adeno Detector Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110722

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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