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 professional use as an aid in the rapid differential diagnosis of acute conjunctivitis.

Negative results do not preclude Adenovirus infection nor are thev 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.

Device Description

The RPS Adeno Detector Plus™ consists of three (3) parts: a Sample Collector, an immunoassay test strip in a plastic Test Cassette housing, and a Buffer. The Sample Collector is used to take a sample of ocular fluid. The separately packaged and sterile Sample Collector has a contoured end with a Dacron fleece to collect the samples. The plastic housing of the Test Cassette body protects the strip from unintended physical influence. Additionally the housing guarantees correct sample transfer onto the lateral flow assay strip. The Buffer is a buffered salt solution containing proteins, detergents and preservatives. The Buffer functions as the solution that initiates the test, extracts the Adenoviral proteins, filters unwanted cellular debris, and transports the immune complex and the control conjugate to the Test and Control Lines on the test strip membrane.

Mechanism of action - RPS Adeno Detector Plus™ is based on the principle of lateral flow immunoassays using Direct Sampling Micro-filtration technology. Viral particles or virus antigens are captured by an antigen specific antibody. A single monoclonal antibody highly specific to the Adenoviral hexon protein is labeled with colloidal gold and also is immobilized as the Test Line.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the RPS Adeno Detector Plus™, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of target sensitivity, specificity, etc. However, the reported performance from the clinical trial is provided. We can infer that the reported values met the unstated acceptance criteria for the FDA to issue a substantial equivalence determination.

Metric	Acceptance Criteria (Implied)	Reported Device Performance	95% Confidence Interval
Sensitivity	Sufficient for clinical aid	90% (28/31)	[74.2-98.0]
Specificity	Sufficient for clinical aid	96% (93/97)	[89.8-98.9]
Negative Predictive Value	Sufficient for clinical aid	97% (93/96)	[91.1-99.3]
Positive Predictive Value	Sufficient for clinical aid	88% (28/32)	[71.0-96.5]

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: N = 128 (Total number of patients in the clinical trial).
Data Provenance: The study design was a prospective, sequential, masked, clinical trial with eight (8) Clinical Trial Sites. The country of origin is not explicitly stated, but the sponsor is based in Sarasota, FL, USA, suggesting the clinical trial was likely conducted in the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth was established by Cell Culture. This is a laboratory diagnostic method and does not involve human experts establishing a subjective ground truth for the test set.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth was established by Cell Culture, which is an objective laboratory method. There was no mention of human adjudication for the Cell Culture results themselves.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study solely evaluated the performance of the device against a gold standard (Cell Culture) and did not involve human readers comparing performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The clinical trial directly assessed the RPS Adeno Detector Plus™ performance (sensitivity, specificity, etc.) against Cell Culture, without any human interaction influencing the device's reading or interpretation for the purpose of the study's primary endpoint. The device itself is a rapid immunoassay test designed for "visual, qualitative in vitro detection," implying human visual interpretation, but the reported performance metrics are for the device's ability to accurately detect Adenovirus compared to culture.

7. Type of Ground Truth Used

The ground truth used was Cell Culture, which is a laboratory-based gold standard for detecting the presence of Adenovirus.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This device is a rapid immunoassay test, not a machine learning or AI-based algorithm that typically requires a distinct training phase with a dedicated dataset. Its development would involve analytical testing and validation rather than "training" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Given that a training set is not mentioned and the device is an immunoassay, the concept of establishing ground truth for a training set in the context of an algorithm's learning is not applicable. The immunoassay operates based on biochemical reactions with a fixed design. Its "training" would be more akin to optimizing reagents and manufacturing processes through bench testing.

Summary

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K110722

MAY 1 7 2011

510(k) Summary of Safety and Effectiveness SECTION 5:

Sponsor Rapid Pathogen Screening, Inc. 7227 Delainey Court Sarasota, FL 34240 Telephone: 941-556-1850 Fax: 941-556-1851 Registration Number: 3006602209

Contact Person: Douglas Bueschel Vice President, Quality Assurance & Regulatory Affairs

5.2 Date Prepared

5.1

May 16, 2011

5.3 Device Information

Proprietary Name: Common Name: Device Category: Product Code: Requlation Number: RPS Adeno Detector Plus™ RPS Adeno Detector Plus Class | GOD 866.3020, Adenovirus Serological Reagents [Antigens, Cf (including control)

5.4 Predicate Device

Rapid Pathogen Screening, Inc .; RPS Adeno Detector (K052092)

5.5 Device Description

Components-

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proteins, filters unwanted cellular debris, and transports the immune complex and the control conjugate to the Test and Control Lines on the test strip membrane.

Mechanism of action -

RPS Adeno Detector Plus™ is based on the principle of lateral flow immunoassays using Direct Sampling Micro-filtration technology. Viral particles or virus antigens are captured by an antigen specific antibody. A single monoclonal antibody highly specific to the Adenoviral hexon protein is labeled with colloidal gold and also is immobilized as the Test Line.

The speed and simplicity of the test enables more appropriate and timely treatment for the patient.

5.6 Intended Use

5.7 Substantial Equivalence

RPS Adeno Detector Plus has substantially equivalent indications to the RPS Adeno Detector (K052092) predicate in that they are indicated for the rapid, visual qualitative in vitro detection of Adenovirus and its serotypes directly from eve fluid on the conjunctiva.

The RPS Adeno Detector Plus uses the same technology as RPS Adeno Detector. The subject device and the predicate device are made from materials which have demonstrated satisfactory biocompatibility and are sterile, single use devices.

5.8 Performance Testing

Biocompatibility Testing - supported by literature.

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In vitro Testing -

The RPS Adeno Detector Plus completed a series of analytical bench tests for sensitivity and specificity.

Animal Studies - Not Applicable.

Clinical Studies -

A Clinical Trial was performed by Rapid Pathogen Screening, Inc. to compare the sensitivity and specificity of the RPS Adeno Detector Plus at detecting the presence of Adenovirus as compared to Cell Culture. The study design was a prospective, sequential, masked, clinical trial with eight (8) Clinical Trail Sites.

Clinical Results 5.9

N = 128		Cell Culture
		+	-
RPS AdenoDetectorPlus	+	28	4
	-	3	93
Sensitivity		90% (28/31)95% CI [74.2-98.0]
Specificity		96% (93/97)95% CI [89.8-98.9]
Negative Predictive Value		97% (93/96)95% CI [91.1-99.3]
Positive Predictive Value		88% (28/32)95% CI [71.0-96.5]

6.0 Conclusion

Rapid Pathogen Screening, Inc. believes that, as a result of the in vitro testing, clinical testing, and literature references supporting biocompatibility, the RPS Adeno Detector Plus is for the rapid, visual, qualitative in vitro detection of Adenovirus and its serotypes directly from eye fluid on the conjunctiva. The RPS Adeno Detector Plus is

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substantially equivalent to the predicate device, RPS Adeno Detector (K052092).

5-4

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Rapid Pathogen Screening, Inc. c/o Robert Sambursky, MD Chief Medical Officer 7227 Delainey Court Sarasota, FL 34240

Re: K110722

Trade/Device Name: RPS Adeno Detector Plus™ Regulation Number: 21 CFR 866.3020 Regulation Name: Adenovirus serological reagents Regulatory Class: Class I Product Code: GOD Dated: March 7, 2011 Received: March 15, 2011

MAY 1 7 2011

Dear Dr. Sambursky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Robert Sambursky, MD

notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Salga Agr.

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device . Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K110722

RPS Adeno Detector Plus™ Device Name:

Indications For Use:

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.

Prescription Use x AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety

Uve Sal

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k v 10722

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Regulation Number and Section

§ 866.3020 Adenovirus serological reagents.

(a)
Identification. Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.