SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST

K061496 · Sa Scientific , Ltd. · MJH · Jun 28, 2007 · Microbiology

Device Facts

• Record ID: K061496
• Device Name: SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
• Applicant: Sa Scientific , Ltd.
• Product Code: MJH · Microbiology
• Decision Date: Jun 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3300
• Device Class: Class 2

Intended Use

The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires’ disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia.

Device Story

SAS™ Legionella Test is a rapid, visually read, in vitro immunochromatographic assay. Input: human urine specimen. Principle: lateral flow immunoassay; urine migrates through sample pad to conjugate pad containing gold-conjugated antibodies specific to Legionella pneumophila antigens; if antigens present, 'half-sandwich' immunocomplex forms; complex migrates to nitrocellulose membrane with immobilized antibodies, forming 'whole sandwich' immunocomplex; visible pink line appears in specimen zone. Procedural control line appears in control zone regardless of antigen presence. Used in clinical settings; performed by healthcare professionals. Output: qualitative visual result (positive/negative). Aids in presumptive diagnosis of Legionnaires' disease in conjunction with culture and other clinical methods.

Clinical Evidence

Retrospective study of 324 frozen specimens compared SAS™ Legionella Cassette test against cell culture. Sensitivity: 90.5% (95% CI 83.2–95.3%); Specificity: 95.0% (95% CI 91.2–97.3%). Analytical specificity evaluated with 49 healthy patient urines (100% negative) and 99 urines from patients with other respiratory infections (99% negative). Reproducibility 100% across three sites.

Technological Characteristics

Immunochromatographic lateral flow assay; cassette format. Utilizes polyclonal antibodies against Legionella pneumophila antigens. Gold-conjugated antibody detection system. Nitrocellulose membrane with immobilized antibodies. Visual readout. No electronic components or software.

Indications for Use

Indicated for presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine for patients with signs and symptoms of pneumonia to aid in the diagnosis of Legionnaires' disease.

Regulatory Classification

Identification

Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identify Haemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Haemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused by Haemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Predicate Devices

• Binax™ Now® Legionella Urinary Antigen Test

Submission Summary (Full Text)

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K061496

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SAS™ Legionella Test

JUN 2 8 2007

The 510(k) summary of safety and effectiveness submission is in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

| Submitted by: | SA Scientific, Ltd.<br>4919 Golden Quail<br>San Antonio, TX 78240 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Reg. No. | 1645225 |
| Contact Person: | Veronica DeLeon |
| Date Prepared: | May 30, 2006 |
| Proprietary Name: | SAS™ Legionella Test |
| Common Name: | SAS™ Legionella Test, SAS™ Legionella pneumophila<br>Test |
| Classification Name: | Legionella, SPP., Elisa |
| Device Classification: | 21 CFR 866.3300 |
| Regulatory Class: | Class II |
| Product Code: | MJH |
| Substantial Equivalence: | Binax™ Now® Legionella Urinary Antigen Test<br>manufactured by Binax™ Inc., Portland, Maine |
| Device Description: | The SAS™ Legionella test utilizes a combination of<br>polyclonal antibodies against the antigens of Legionella<br>pneumophila. The SAS™ Legionella test begins with<br>the addition of urine to the test device. The specimen is<br>absorbed by the sample pad and then moves through<br>the conjugate pad which contains dried gold conjugated<br>antibodies which are specific for Legionella<br>pneumophila antigens; if the Legionella antigens are<br>present in the urine sample, a "half-sandwich"<br>immunocomplex is formed. This immuno-complex then<br>migrates via capillary action along a nitrocellulose<br>membrane containing immobilized antibodies to<br>Legionella pneumophila antigens. The immobilized<br>antibodies bind the "half-sandwich" immuno-complex to |

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form a "whole sandwich" immuno-complex. Thus, when the "whole sandwich" is formed, a visible, pink colored line develops in the specimen zone on the test device. In the absence of a Legionella antigen, a "sandwich" immuno-complex is not formed and a negative result is indicated. To serve as a procedural control, a pink colored control line will always appear in the control zone regardless of the presence or absence of Legionella antigen. The test is available in cassette format.

Intended Use: The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires' disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only.

Quality Controls: The SAS™ Legionella Test provides two (2) internal procedural controls. It is recommended that external quality controls should be performed on each new test kit box opened. Positive and negative external controls are supplied separately.

Device Comparison: The SAS™ Legionella Test and Binax™ Now® Legionella Urinary Antigen Test are rapid immunoassays tests utilizing immunochromatographic technology for the visualization of Legionella pneumophila antigen. Each utilizes an antibody conjugated to colored particles and an antibody printed onto a membrane.

Performance Summary: The SAS™ Legionella Test performed substantially equivalent to the predicate device, Binax™ Now® Legionella Urinary Antigen Test and to culture. This was verified by comparison of frozen and fresh urine specimens.

> Cross reactivity and interference studies were performed on viral and bacterial strains commonly found in human urine. None of the organisms interfered or cross-reacted with the performance of the SAS™ Legionella Test.

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Prepared by: Veronica De Leon
Regulatory Affairs

Date: 6/21/07

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Image /page/3/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services (USA). The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the perimeter of the logo. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person embracing another person.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 8 2007

Veronica DeLeon Regulatory Affairs SA Scientific, Ltd. 4919 Golden Quail San Antonio, TX 78240

Re: k061496

Trade/Device Name: SAS™ Legionella Test Regulation Number: 21CFR 866. 3300 Regulation Name: Haemophilus spp. Serological Reagents Regulatory Class: Class II Product Code: MJH Dated: May 30, 2006 Received: May 31, 2006

Dear Ms. DeLeon:

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

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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 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/dsma/dsmamain.html.

Sincerely yours,

Sallanz

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

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## INDICATIONS FOR USE

Applicant: SA Scientific, Inc. 4919 Golden Quail San Antonio, TX. 78240 Ph: [phone] Fax: [phone]

Establishment Reg. No .: 1645225

501(k) Number: 06 / 496

Device Names:

SAS™ Legionella Test

Indications for Use:

The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires' disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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