Cleared Traditional

K110722 - RPS ADENO DETECTOR PLUS

K110722 is an FDA 510(k) clearance for RPS ADENO DETECTOR PLUS, manufactured by Rapid Pathogen Screening, Inc.. The device is a Class 1 Microbiology device with product code GOD cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K110722 · Rapid Pathogen Screening, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
63d
Days
Class 1
Risk

K110722 is an FDA 510(k) clearance for the RPS ADENO DETECTOR PLUS. Classified as Antigens, Cf (including Cf Control), Adenovirus 1-33 (product code GOD), Class I - General Controls.

Submitted by Rapid Pathogen Screening, Inc. (Sarasota, US). The FDA issued a Cleared decision on May 17, 2011 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3020 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rapid Pathogen Screening, Inc. devices

FDA 510(k) Submission Details - K110722

510(k) Number K110722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2011
Decision Date May 17, 2011
Days to Decision 63 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 102d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

GOD Device Classification - Class 1, General Controls

Product Code GOD Antigens, Cf (including Cf Control), Adenovirus 1-33
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3020
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Clinical Evidence

ClinicalTrials.gov
NCT00921895 Completed Interventional Industry-sponsored

A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis

A Comparison of the Sensitivity and Specificity of the RPS Adeno Detector IV™ at Detecting the Presence of Adenovirus to Viral Cell Culture.

128
Patients (actual)
8
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Conjunctivitis
Study design Single group
Eligibility All sexes · 1 Year+
Principal investigator Shachar Tauber, MD
Sponsor Rapid Pathogen Screening (industry)
Started 2009-06-01 → Primary completion 2011-06-01
Primary outcome
Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.
View full study on ClinicalTrials.gov

Regulatory Peers - GOD Antigens, Cf (including Cf Control), Adenovirus 1-33

Devices cleared under the same product code (GOD) and FDA review panel - the closest regulatory comparables to K110722.
RPS ADENO DETECTOR
K052092 · Rapid Pathogen Screening · Nov 2005
SAS ADENO TEST
K990630 · Sa Scientific, Inc. · Aug 1999
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
K972406 · Immunoprobe, Inc. · Dec 1997
ADENOLEX (R) LATEX AGGLUTINATION TEST
K864645 · Orion Diagnostica, Inc. · Jun 1987
ADENO VIRUS & CONTROLS
K802929 · Orion Diagnostica, Inc. · Dec 1980