RPS ADENO DETECTOR

K052092 · Rapid Pathogen Screening · GOD · Nov 22, 2005 · Microbiology

Device Facts

• Record ID: K052092
• Device Name: RPS ADENO DETECTOR
• Applicant: Rapid Pathogen Screening
• Product Code: GOD · Microbiology
• Decision Date: Nov 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3020
• Device Class: Class 1

Indications for Use

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.

Device Story

Point-of-care diagnostic test for acute adenoviral conjunctivitis; utilizes lateral flow immunochromatography to detect hexon protein antigen in human eye fluid. Physician or healthcare professional collects tear sample from inferior fornix using sterile swab; sample transferred to immunoassay cassette; reacts with colloidal gold-labeled antibody and immobilized antibody on strip. Results appear visually within 10 minutes as red lines; control line indicates test validity; test line indicates presence of adenoviral antigen. Provides rapid differential diagnosis aid; negative results require confirmation via cell culture. Benefits include faster clinical decision-making compared to 2-week cell culture turnaround.

Clinical Evidence

Clinical study of 175 patients with red eye symptoms (within 7 days of onset). Compared to viral cell culture (gold standard). Sensitivity: 88% (95% CI: 74.4%-96%); Specificity: 91% (95% CI: 84.8%-95.2%); Positive Predictive Value: 76%; Negative Predictive Value: 96%. Overall agreement: 90%. 3 of 12 culture-negative/test-positive samples were PCR positive.

Technological Characteristics

Lateral flow immunochromatography; detects hexon protein antigen. Disposable immunoassay cassette; colloidal gold-labeled antibody; immobilized antibody detection zone. Point-of-care, manual operation. No electronic components or software.

Indications for Use

Indicated for the detection of adenoviral antigens in human eye fluid (tears) in patients presenting with symptoms of acute infectious conjunctivitis. For use by health professionals only.

Regulatory Classification

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).

Predicate Devices

• SAS Adeno Test (K990630)

Reference Devices

• Adenoclone (Meridian, Inc.)

Submission Summary (Full Text)

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# NOV 2 2 2 2005

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## 510-K SUMMARY OF SAFETY AND EFFECTIVENESS

| Assigned 510-K Number: | K052092 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Rapid Pathogen Screening, Inc.<br>101 Phillips Park Drive<br>South Williamsport, PA 17702 |
| Submission Contact: | Robert Sambursky, MD |
| Date Prepared: | September 14, 2005 |
| Device Trade Name: | RPS Adeno Detector |
| Predicate Devices: | SA Scientific, Inc.<br>SAS Adeno Test<br>K990630 |
| Device Classification: | Adenovirus serological reagents are devices that<br>consist of antigens and antisera used in serological<br>tests to identify antibodies to adenovirus in serum.<br>The identification aids in the diagnosis of disease<br>caused by adenoviruses and provides<br>epidemiological information on these diseases.<br>Adenovirus infection may cause pharyngitis, acute<br>respiratory diseases, gastroenteritis, and<br>conjunctivitis |
| I. Device Category: | Class I<br>RPS Adeno Detector differs from serologic tests by<br>its ability to directly detect the antigen, a conserved<br>epitope on the hexon portion of the adenovirus,<br>which is characteristic and consistent for all<br>serotypes. |
| II. Product Code: | GOD |
| III. Regulation Number: | 866.3020; Adenovirus serological reagents<br>[Antigens, Cf (including control)]. |
| Intended Use: | The RPS Adeno Detector is a rapid<br>immunochromatography test for visual, qualitative<br>in-vitro detection of adenoviral antigens (hexon<br>protein) directly from human eye fluid. The test is |

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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.

- 1. Indication(s) for use: Local (in tears of the eye) adenovirus detection associated with acute infectious conjunctivitis
- Special condition for use statement(s): 2. For use by health professionals only
- Special instrument Requirements 3. None

Morphologically, adenoviruses are nonenveloped DNA viruses with an icosahedral structure about 80 nm in diameter [4]. Adenovirus has been implicated in diseases affecting the respiratory, ocular and gastrointestinal systems [1], [2], [3].

Adenovirus is a frequent cause of infectious conjunctivitis. Human adenoviruses are classified into 6 subgenera and 51 serotypes [6],[10]. Approximately one third of the human adenovirus serotypes have been associated with common forms of adenoviral related eye infections [11] but the most common causes of acute conjunctivitis are related to serotypes 3, 4, 8, 11, 19 and 37 [12]. The serotypes have the following associations: serotypes 8, 19 and 37 are most responsible for epidemic keratoconjunctivitis [13],[14],[15]; serotypes 3, 4, 5 and 7 tend to cause pharyngeal-conjunctival fever, which usually affects children [13]; serotypes 1-11 and 19 are the primary cause of nonspecific follicular conjunctivitis [13]. However, the other serotypes can also produce clinically indistinguishable episodes of acute follicular conjunctivitis [4], [14], [16].

Cell culture in combination with immunofluorescence remains the "gold standard" for identifying adenovirus in conjunctival specimens [5]. Virus isolation requires a laboratory infrastructure, technical expertise, and may take up

Physiologic Basis of the Test:

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to 2 weeks to complete. In addition, the differential diagnosis of various forms of conjunctivitis (viral, bacterial, allergic) is often difficult because they manifest similar symptoms.

#### Device Description:

The RPS Adeno Detector utilizes technology based on lateral flow immunochromatography. Adenoviral antigen, hexon protein, when present in the patient sample is captured between two antigen specific antibodies. One antibody is immobilized in the detection zone of the device. The second antibody is labeled with colloidal gold. The detector is a disposable, rapid test requiring 10 minutes for a result.

The patient's lower eyelid is gently retracted to expose the inferior fornix. The eye fluid is collected on the sterile sample collector by gently swabbing the inferior fornix with the sampling pad on the test cover to gain a sample of tears for point of care analysis. The sample collector is reassembled to the immunoassay cassette. Sample transfer happens automatically.

Analysis of the sample starts when the absorbant pad of the strip is dipped into a provided buffering solution. After 1-10 minutes, red colored lines in the read out area will appear. One line (control line) only indicates a (Adenoviral) negative result, where as two lines (control line and test line) indicate a (Adenoviral) positive result.

It is best used within 7 days of developing a red eye consistent with infectious conjunctivitis.

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## Predicate device Comparison

| Features | RPS Inc.<br>RPS Adeno Detector | Cell Culture | SA Scientific, Inc.<br>SAS Adeno Test |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| K Number | K052092 | None | K990630 |
| Intended Use | The RPS Adeno<br>Detector allows for the<br>rapid, visual,<br>qualitative in vitro<br>detection of<br>adenovirus and its<br>serotypes directly<br>from eye fluid on the<br>conjunctiva. | The gold standard for<br>the qualitative<br>determination<br>Adenovirus from<br>conjunctival swabs | A rapid test for the<br>qualitative<br>determination of in<br>vitro Adenovirus<br>antigen from<br>conjunctival swabs |
| Specimen<br>Types | Eye conjunctival<br>mucosa swab | Conjunctival swab | Conjunctival swab |
| Matrix | Eye fluid | Eye fluid | Eye fluid |
| Techno-logy | Lateral flow<br>immunoassay | Growth on hepatic<br>cells; confirmatory<br>immunofluorescence | Lateral flow<br>immunoassay |
| Antigen<br>Detected | Adenovirus | Living Adenovirus | Adenovirus |
| Predicate<br>Devices | SA Scientific, Inc.<br>SAS Adeno Test | None | Meridian, Inc.<br>Adenoclone |

### Summary of Performance Data:

### Clinical Studies

A total of 175 samples were collected and tested from patients who developed a red eye consistent with infectious conjunctivitis within the last 7 days.

Clinical performance data of the RPS Adeno Detector compared against viral cell culture are summarized in the following scheme:

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| | Viral Culture | |
|-----------------------|---------------|-----|
| RPS Adeno<br>Detector | ± | = |
| | ± | 37 |
| = | 5 | 121 |

| Sensitivity: | 88% (37/42), 95% CI (confidence interval) = 74.4%-96% |
|----------------------------|-------------------------------------------------------|
| Specificity: | 91% (121/133), 95% CI = 84.8% - 95.2% |
| Overall agreement: | 90% (158/175), 95% CI = 84.9% - 94.2% |
| Positive predictive value: | 76% (37/49), 95% CI = 61.1% - 86.7% |
| Negative predictive value: | 96% (121/126), 95% CI = 91% - 98.7% |

* Out of the 12 culture negative RPS positive samples 3 were found to be PCR positive

### Conclusion:

Analytical testing, including analytical sensitivity, specificity, cross-reactivity, and interference were conducted. These studies further demonstrated the suitability of the product for professional use as a point of care device. Such studies also established both the substantial equivalence of the RPS Adeno Detector to viral culture and the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 2 2005

Rapid Pathogen Screening, Inc. c/o Robert Sambursky, M.D. 13946 Wood Duck Circle Bradenton, FL 34202

Re: k052092

Trade/Device Name: RPS Adeno Detector Regulation Number: 21 CFR 866.3020 Regulation Name: Adenovirus Serological Reagents Regulatory Class: Class I Product Code: GOD Dated: September 23, 2005 Received: September 29, 2005

#### 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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sales a Hogg

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): K 052092

Device Name: RPS Adeno Detector

Indications For Use:

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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sally Austin

Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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KOS 2092 510(k)_