RSV OIA

K021172 · Thermo Biostar, Inc. · GOG · Sep 13, 2002 · Microbiology

Device Facts

• Record ID: K021172
• Device Name: RSV OIA
• Applicant: Thermo Biostar, Inc.
• Product Code: GOG · Microbiology
• Decision Date: Sep 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3405
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The Thermo BioStar™ RSV OIA® assay is an Optical Immunoassay (OIA) test for the qualitative, rapid detection of respiratory syncytial virus antigens (nucleoprotein and fusion protein) from nasal wash specimens. This test is intended for in vitro diagnostic use to aid in the diagnosis of respiratory syncytial virus infections in symptomatic neonatal and pediatric patients under the age of five. It is recommended that all negative test results be confirmed by cell culture.

Device Story

RSV OIA is a rapid, qualitative in vitro diagnostic test for RSV antigens (nucleoprotein and fusion protein) in nasal wash specimens. It utilizes Optical ImmunoAssay (OIA) technology, where antigen-antibody binding on a silicon wafer surface increases the thickness of a molecular thin film. This change in optical thickness alters the reflected light path, producing a visible color change (purple spot on gold background) within 20 minutes. Used in clinical settings by healthcare professionals; results provide rapid diagnostic information to aid clinical decision-making. Unlike traditional culture methods requiring >48 hours, OIA provides immediate results, though negative results require confirmation by cell culture.

Clinical Evidence

Clinical study enrolled 267 patients (241 analyzed). Compared RSV OIA to cell culture with fluorescent antibody staining confirmation. Sensitivity and specificity were 86.2%. Overall PPV 67.1%, NPV 94.1%. Reproducibility study (n=162) across six sites (hospitals and physician offices) showed 95% reproducibility. Analytical testing assessed specificity, cross-reactivity, and potential interference from blood and OTC products.

Technological Characteristics

Optical ImmunoAssay (OIA) technology using molecular thin films on a silicon wafer substrate. Qualitative visual detection of antigen-antibody binding via color change. Manual test format; no electronic components or software. Not applicable for connectivity or algorithm classification.

Indications for Use

Indicated for symptomatic neonatal and pediatric patients under age five to aid in diagnosis of respiratory syncytial virus (RSV) infections using nasal wash specimens.

Regulatory Classification

Identification

Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.

Predicate Devices

• AB FLU OIA (K981651)
• Directigen Respiratory Syncytial Virus Test Kit (K882629)

Submission Summary (Full Text)

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#### 510(k) SUMMARY (page 1 of 3) 8.0

SEP 1 3 2002

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K021172

A. Safety and effectiveness information required per [§807.92(a)(1)]:

- SUBMITTER'S NAME: Thermo BioStar, Inc. .
- ADDRESS: 331 South 104th Street, Louisville, CO 80027 .
- TELEPHONE: [phone] ext. 612 ●
- . FAX: [phone]
- CONTACT PERSON: John G. Adams
- DATE 510(k) SUMMARY PREPARED: April, 2002 .

B. Safety and effectiveness information required per [§807.92(a)(2)]:

- TRADE OR PROPRIETARY NAME: RSV OIA® ●
- . COMMON NAME: Respiratory Syncytial Virus assay
- CLASSIFICATION NAME: Antigen, , CF (including CF Controls), Respiratory Syncytial Virus
- C. Identification of legally marketed device to which we are comparing performance.

Device Technology:

Trade or Proprietary Name: AB FLU OIA Regulatory Class: I Manufacturer: Thermo BioStar K981651 510(k) Number:

Clinical application:

Trade or Proprietary Name: Directigen Respiratory Syncytial Virus Test Kit Regulatory Class: T Manufacturer: Becton Dickinson 510(k) Number: K882629

Historical Reference Method:

Viral Culture

E. Intended use of device [§807.92(a)(5)]:

The Thermo BioStar® RSV OIA assay is an Optical ImmunoAssay (OIA) test for the qualitative, rapid detection of respiratory syncytial virus antigens (nucleoprotein) from nasal wash specimens. This test is intended for in vitro use to aid in the diagnosis of respiratory syncytial virus infections in symptomatic neonatal and pediatric patients under the age of five. It is recommended that all negative results be confirmed by cell culture.

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#### 8.0 510(k) SUMMARY (page 2 of 3)

### D. Description of device [§807.92(a)(4)]:

#### Principle of the Test:

The RSV OIA test involves the qualitative extraction and detection of protein antigens unique to RSV (nucleoprotein and fusion protein). The Optical ImmunoAssay technology enables the direct visual detection of a physical change in the optical thickness of molecular thin films. This change is a result of antigenantibody binding on an optical surface (silicon wafer). When an extracted specimen is placed directly on the optical surface, the immobilized specific antibodies capture the antigen. After washing, the substrate is added, increasing the thickness (mass enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color change. Slight changes in optical thickness produce a distinct, visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the surface retains the original gold color indicating a negative result.

#### DEVICE COMPARISON:

#### Device Technology:

The RSV OIA assay is similar to the FLU OIA assay in that:

- Both assays are rapid diagnostic tests that utilize Optical ImmunoAssay technology ●
- Both assays are used to detect and identify antigen proteins specific to respiratory infections. ●
- Both assays can provide results in less than 20 minutes. ●
- . Both assavs are qualitative.

The RSV OIA assay differs from the currently marketed FLU OIA assay in that:

- RSV OIA assay detects an antigen unique to respiratory syncytial virus. ●
- RSV OIA assay specimen types are limited to nasal wash specimens, and do not include throat . specimens.

#### Device clinical application:

The RSV OIA assay is similar to the Directigen Respiratory Syncytial Virus Test in that:

- Both assays are rapid diagnostic tests that detect RSV antigen ●
- Both assays can provide results in less than 20 minutes .
- Both assays are qualitative. ●
- . Both assays utilize visual detection for confirmation of reactivity.

The RSV OIA assay differs from the Directigen Respiratory Syncytial Virus Test in that:

- Directigen employs an immunomembrane filter , OIA utilizes molecular thin film technology ●
- . Reaction results with OIA can provide a permanent record; Directigen results disperse and fade after a finite time.

#### Comparison to historical standard method:

The RSV OIA assay is similar to culture methods in that:

- Both assays are used to detect and identify respiratory syncytial virus. ●
- Both assays can detect the RSV virus from nasal wash specimens. ●
- Both assays are qualitative

The RSV OIA assay differs with traditional culture methods in that:

- RSV OIA assay detects an antigen unique to the respiratory syncytial virus while the traditional culture ● methods detect the whole living organism.
- . RSV OIA assay can provide results in less than 20 minutes, in contrast to culture methods that can take in excess of 48 hours.

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#### 8.0 510(k) SUMMARY (page 3 of 3)

#### SUMMARY OF PERFORMANCE DATA:

#### CLINICAL STUDIES

Performance characteristics for the RSV OIA assay were initially established in a two-site study in patients from emergency rooms and health clinics.

- H. Summary of clinical testing [§807.92(b)(2)]:
#### Reproducibility

Reproducibility testing was conducted at four hospital laboratories and two physician office laboratories (POL). Nine blinded samples were tested at each site at three separate times (n=162). Samples consisted of negative, low and moderate levels of RSV antigen, and the Kit positive controls. These samples were prepared in buffered protein solution, and were spiked onto swabs for analysis. The reproducibility study included both the swab extraction and OIA testing of the antigen associated with RSV.

There were no significant differences in performance among the sites. There were a total of 8 discordant results and 3 invalid results determining an overall reproducibility of 95%.

#### Clinical Sensitivity and Specificity

A study was conducted comparing the RSV OIA test to commercially available cell culture, with confirmation and typing by fluorescent antibody staining. Secondary confirmation testing of specimens positive to OIA and negative to culture was done by specific nucleic acid detection by PCR. A total of 267 patients were enrolled into the clinical study. A total of 241 nasal wash specimens were included in the data analysis, with 26 specimens excluded.

The RSV OIA assay was evaluated versus cell culture with confirmation and typing by fluorescent antibody staining. Sensitivity and specificity for symptomatic patients was 86.2% respectively. Overall PPV and NPV for the clinical specimens were 67.1% and 94.1% respectively.

- 1. Conclusions from nonclinical / clinical testing [§807.92(b)(3)]:
Analytical testing was performed on both microbial and viral panels to assess specificity and cross reactivity.

Whole blood and several types of over the counter (OTC) products were evaluated to assess the potential for interference.

The results of the above described internal and external studies demonstrated that the RSV OIA test is as safe and effective as the comparative devices.

- J. Additional information [§807.92(d)]:
No additional information has been requested by FDA at this time.

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Image /page/3/Picture/1 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 a stylized symbol of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# SEP 1 3 2002

Mr. John G. Adams Regulatory Affairs Thermo BioStar, Inc. 331 South 104th Street Louisville, CO 80027

Re: k021172

> Trade/Device Name: RSV OIA® Test Kit Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory Syncytial Virus Serological Reagents Regulatory Class: Class I Product Code: GOG Dated: August 8, 2002 Received: August 13, 2002

Dear Mr. Adams:

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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K021172

Device Name: Thermo BioStar RSV OIA

Indications For Use: The Thermo BioStar™ RSV OIA® assay is an Optical Immunoassay (OIA) test for the qualitative, rapid detection of respiratory syncytial virus antigens (nucleoprotein and fusion protein) from nasal wash specimens. This test is intended for in vitro diagnostic use to aid in the diagnosis of respiratory syncytial virus infections in symptomatic neonatal and pediatric patients under the age of five. It is recommended that all negative test results be confirmed by cell culture.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Feededinte. Paolo

(Division Sign-Off) for D.R. DuBois

Division of Clinical Laboratory Devices

510(k) Number K021172

(Optional Format 3-10-98)

Prescription Use Only.