MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

K070522 · Inverness Medical Professional Diagnostics · MJH · Mar 15, 2007 · Microbiology

Device Facts

• Record ID: K070522
• Device Name: MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
• Applicant: Inverness Medical Professional Diagnostics
• Product Code: MJH · Microbiology
• Decision Date: Mar 15, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3300
• Device Class: Class 2

Intended Use

The Binax NOW® Legionella Urinary Antigen Test is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection ("Legionnaires" Disease) caused by L. pneumophila serogroup 1 in conjunction with culture and other methods.

Device Story

Binax NOW® Legionella Urinary Antigen Test is a lateral flow immunochromatographic assay for qualitative detection of L. pneumophila serogroup 1 antigen in human urine. Device consists of a cardboard, book-shaped hinged test device containing a test strip with gold-conjugated and immobilized anti-L. pneumophila serogroup 1 antibodies, and a swab well. User dips a Dacron swab into urine, inserts it into the well, and adds a reagent. Antigen in urine binds to conjugated antibodies, forming a visible Sample Line; control antibodies form a Control Line. Results are available in 15 minutes. Used in clinical settings to aid diagnosis of Legionnaires' disease in conjunction with culture and other methods. Provides rapid presumptive results to assist healthcare providers in clinical decision-making and patient management.

Clinical Evidence

Bench testing only. Method comparison performed on 70 urine samples from healthy individuals (100% agreement) and 15 known positive specimens (100% agreement). Cross-reactivity testing on 11 organisms associated with pneumonia or urogenital flora showed no positive results. Loss of signal testing confirmed equivalent sensitivity to the predicate device across serial dilutions.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: cardboard hinged test device, Dacron swab. Detection principle: gold-conjugated and immobilized anti-Legionella pneumophila serogroup 1 antibodies. Manual procedure; no electronic components or software.

Indications for Use

Indicated for patients with symptoms of pneumonia to aid in the presumptive diagnosis of Legionella pneumophila serogroup 1 infection (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 (unmodified) (K982238)

Submission Summary (Full Text)

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# 510(k) Summary

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

### SUBMITTER

Binax, Inc. d/b/a Inverness Medical Professional Diagnostics 10 Southgate Road Scarborough, Maine 04074

MAR 1 5 2007

#### CONTACT PERSON

Karen Mortimer [phone] (Office) [phone] (Fax) [e-mail]

#### ALTERNATE CONTACT

Pamela Angell [phone] (Office) [phone] (Fax) [e-mail]

#### DATE PREPARED

February 13, 2007

#### TRADE NAME

Binax NOW® Legionella Urinary Antigen Test

### COMMON NAME

Legionella ICT

### CLASSIFICATION NAME

Haemophilus spp. Serological reagents (per 21 CFR 866.3300)

#### PREDICATE DEVICE

Binax NOW® Legionella Urinary Antigen Test (unmodified) 510 (k) number K982238

#### DEVICE DESCRIPTION

The Binax NOW® Legionella Urinary Antigen Test is an immunochromatographic membrane assay to detect Legionella pneumophila serogroup 1 antigen in human urine. A test strip, containing gold-conjugated and immobilized anti-Legionella pneumophila serogroup 1 antibodies, and a swab well are mounted on opposite sides of a cardboard, book-shaped hinged test device. A Dacron swab is dipped into the urine to be tested and then inserted into the swab well. A single reagent is added to the swab well from a dropper bottle before closing Legionella urinary antigen captured by immobilized anti-Legionella the test device. pneumophila antibody reacts to bind anti-Legionella pneumophila conjugated antibody, forming the Sample Line. Immobilized control antibody captures anti-species conjugate, forming the Control Line. There are no transferring steps, the sample is contained, and results are available in 15 minutes.

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# nary (contir

#### INTENDED USE

The Binax NOW® Legionella Urinary Antigen Test is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection ("Legionnaires" Disease) caused by L. pneumophila serogroup 1 in conjunction with culture and other methods.

#### TECHNOLOGICAL CHARACTERISTICS

The Binax NOW® Legionella Urinary Antigen Test uses lateral flow immunochromatographic technology. The test is a rapid immunoassay that employs specific antibodies immobilized onto a solid phase to capture and visualize Legionella pneumophila serogroup 1 antigen. (The modified and cleared Binax NOW® Legionella Urinary Antigen Tests share the same technological characteristics and antigen detection reagents. Assay procedure, intended use and product claims are unchanged for the modified device.)

#### PERFORMANCE SUMMARY

Stability, Method Comparison, Cross Reactivity and Loss of Signal testing were performed on the modified device to ensure its equivalence to the unmodified device. The changes to the NOW® Legionella Urinary Antigen Test have not affected its safety or effectiveness as detailed below:

#### STABILITY STUDIES:

Stability studies of the modified test are currently ongoing,

#### METHOD COMPARISON:

Seventy (70) urine samples, collected from presumed healthy individuals, were tested on the modified and cleared devices yielding negative results and demonstrating 100% agreement between the two devices. Fifteen (15) known positive urine specimens were tested on the modified and unmodified devices yielding positive results and again demonstrating 100% agreement.

#### CROSS-REACTIVITY TESTING:

In the original 510(K) submission, cross reactivity testing was performed using urines from patients diagnosed with other (non-Legionella) bacterial or fungal pneumonia or urinary tract infections. In lieu of this, whole organism cross-reactivity testing was performed to compare the modified and unmodified devices.

Given that modifications to the device do NOT impact the detection portion of the assay, a limited cross-reactant panel of 11 organisms was tested. The panel included organisms associated with pneumonia as well as those likely to be found in the urogenital tract as normal flora or as the result of a urinary tract infection. None of the organisms, grown in culture and tested at clinically relevant concentrations (depending on the organism 1 x 10° to 2 x 103), tested positive on the modified test.

#### LOSS OF SIGNAL (LOS) TESTING:

Serial two-fold dilutions of a known positive urine specimen were run on the unmodified and modified devices. Three (3) separate lots of the modified device were tested against

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# 510 (k) Summary (continued) 11:40:00

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unmodified devices. In all three studies, the same dilution of the positive urine provided loss of signal on both the unmodified and modified devices.

lifell and amo 2116/07 ______________________________________________________________________________________________________________________________________________________________________________ Signed

Pamela Angell, Director, Worldwide Clinical Affairs Binax, Inc. d/b/a Inverness Medical Professional Diagnostics

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Karen Mortimer Clinical Affairs Specialist Binax, Inc. Inverness Medical Professional Diagnostics 10 Southgate Road Scarborough, ME 04074

MAR 1 5 2007

Re: k070522

Trade/Device Name: BinaxNOW® Legionella Urinary Antigen Test Regulation Number: 21 CFR 866.3300 Regulation Name: Haemophilus spp. serological reagents Regulatory Class: Class II Product Code: MJH Dated: February 14, 2007 Received: February 23, 2007

Dear Ms. Mortimer:

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). 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,

Sally, attorn

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 STATEMENT

510(k) Number (if known): _ Kn 705 32

Device Name: BinaxNOw® Legionella Urinary Antigen Test

# Indications For Use:

The Binax NOW® Legionella Urinary Antigen Test is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection (Legionnaires' disease) caused by L. pneumophila serogroup 1 in conjunction with culture and other methods.

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

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

Freddie Lu-Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

070522