BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522

K982238 · Binax, Inc. · MJH · Aug 21, 1998 · Microbiology

Device Facts

• Record ID: K982238
• Device Name: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522
• Applicant: Binax, Inc.
• Product Code: MJH · Microbiology
• Decision Date: Aug 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3300
• Device Class: Class 2

Intended Use

The Binax NOW™ Legionella Urinary Antigen Test is a rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in human urine as an adjunct to culture for the presumptive diagnosis of Legionnaires' Disease. It is intended for in vitro diagnostic use.

Device Story

Device is a rapid, book-shaped, hinged immunochromatographic test for Legionella pneumophila serogroup 1 antigen in human urine. Input: dacron swab dipped in urine sample, inserted into test well with added reagent. Principle: soluble antigen binds to gold-conjugated anti-Legionella pneumophila serogroup 1 antibodies on a membrane solid phase. Output: visual presence or absence of two pink-to-purple colored lines on the test strip. Used in clinical settings; results available in 15 minutes. No transfer steps required; sample contained within device. Healthcare providers interpret results visually to aid in the presumptive diagnosis of Legionnaires' Disease, facilitating timely clinical decision-making.

Clinical Evidence

Bench testing and clinical performance evaluation conducted. Sensitivity and specificity determined using 300 characterized frozen urine specimens compared to clinical diagnosis (culture, RIA, DFA, or IFA). NOW™ sensitivity 97% (vs 95% predicate); specificity 98% (vs 94% predicate). Cross-reactivity evaluated with 200 urine specimens positive for other bacterial/fungal infections; 196/200 tested negative (98% specificity). Reproducibility study at 3 sites with 360 samples showed 100% correct interpretation. Quality control study confirmed device ability to indicate invalid results.

Technological Characteristics

Immunochromatographic membrane assay. Materials: dacron swab, cardboard hinged test device, colloidal gold conjugate, polyclonal rabbit antibodies. Sensing principle: lateral flow immunoassay. Energy source: none (manual). Form factor: book-shaped hinged device. Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine as an adjunct to culture for presumptive 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 Legionella Urinary Antigen EIA (K934965/S1)

Submission Summary (Full Text)

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AUG 21 1998

Binax, Inc. Binax NOW™ Legionella Urinary Antigen Test 510(k) Notification

Vital Information ... NOWTM

## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS Binax NOW™ Legionella Urinary Antigen Test

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

Submitter:

Binax, Inc. 217 Read Street Portland, Maine 04103

Pamela S. Angell Attention: [phone] Office [phone] FAX

Binax NOW™ Legionella Urinary Antigen Test Trade Name:

Common Name: Legionella ICT

Haemophilus spp. serological reagents (per Classification Name: 21 CFR 8660.3300)

Binax Legionella Urinary Antigen EIA, 510(k) Predicate Device: number K934965/S1

The Binax NOW™ Legionella Urinary Antigen Device Description: Test is an immunochromatographic membrane detect Legionella pneumophila assay to serogroup 1 antigen in human urine. A test gold-conjugated and strip, containing anti-Legionella pneumophila immobilized 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 the Soluble antigen captured by test device. anti-Legionella pneumophila immobilized bind the serogroup 1 antibody reacts to visualizing gold-conjugate. There are no transferring steps, the sample is contained, and results are available within 15 minutes.

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Binax, Inc. Binax NOW™ Legionella Urinary Antigen Test 510(k) Notification

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)

NOWTMLegionella Urinary Antigen Intended Use: Binax The Test is intended for in vitro diagnostic use qualitatively detect the presence of to Legionella pneumophila serogroup 1 soluble antigen in human urine. The indication statements are the same as those made for the predicate device.

Technological Characteristics : Both the Binax NOW™ Legionella Urinary and the Binax Legionella Urinary Antigen Antigen EIA tests use a solid phase coated with polyclonal rabbit antibody to detect Legionella pneumophila serogroup 1 antigen samples. However, in human urine the predicate device is an enzyme immunoassay a horseradish peroxidase employing (EIA) conjugate and a microtiter well solid phase, Binax NOW™ Legionella Urinary while the Test is an immunochromatographic Antigen assay utilizing a colloidal gold conjugate and a membrane solid phase. Furthermore, the predicate device is a multi-step assay requiring calculation of a ratio for result interpretation while the NOW™ membrane test simple and rapid test interpreted is a visually by the presence or absence of two pink-to-purple colored lines.

Performance Summary: The Binax NOW™ Legionella Urinary Antigen Test for Legionella pneumophila serogroup 1 antigen in urine is substantially equivalent predicate device, Binax Legionella to the Antigen EIA (K934965/S1) . The Urinary performance of the Binax NOW™ Legionella Test was verified by Antigen Urinary specificity, and sensitivity, reproducibility studies using well characterized frozen urine specimens and Refer to attached volunteer urine donors. CHARACTERISTICS. PERFORMANCE

Signed J.
Date 2/6/98
J. Georges Nitis, Ph.D., MBA
Director, Regulatory Affairs

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Binax. Inc. Binax NOW™ Legionella Urinary Antigen Test 510(k) Notification

## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)

## PERFORMANCE CHARACTERISTICS

## BINAX NOW™ LEGIONELLA URINARY ANTIGEN TEST

#### Sensitivity and Specificity:

Because of the low rate of positivity of Legionella pneumonia, test sensitivity and specificity were determined by testing 300 well characterized frozen urine specimens in both the Binax NOW™ Legionella (NOW™) and in the Binax Legionella Urinary Antigen EIA The University of Indiana conducted all testing. (EIA) Tests. EIA and NOW™ test sensitivity and specificity were calculated based on performance versus Clinical Diagnosis. Specimens were considered true positives when the presence of infection was confirmed by culture, RIA, DFA or IFA.

NOW™ test sensitivity is 97% compared to 95% for the predicate device. Now™ test specificity is 98% compared to 94% for the predicate device.

### Cross-Reactivity :

for Legionella pneumophila The 200 urines presumed negative serogroup 1 were positive for other bacterial or fungal pneumonia or urinary tract infections, allowing a comparison of the NOW™ and predicate device cross-reactivities. One hundred ninety six (196) of the 200 patient specimens produced negative results in the NOW™ test for a specificity of 98%.

further demonstrate Binax test specificity, 106 presumed To negative urine specimens were tested in the Binax NOW™ Legionella Urinary Antigen Test. All specimens tested negative.

#### Reproducibility:

A blind study of the NOW™ test was conducted at 3 separate sites panel of coded specimens containing negative, low using a positive, moderate positive and high positive swabs. Individuals diverse educational backgrounds performed testing on ਤੇ of different days. One hundred percent (100%) of the 360 samples tested were correctly interpreted.

### Quality Control:

The ability of the Binax NOW™ Legionella Urinary Antigen Test control to indicate test failure was evaluated when 3 operators each ran 20 kit controls in a panel of 20 devices, 9 of which had been rendered inoperative. The number of defective devices and the defect itself were not apparent to the operator. All ୧୦ devices were correctly interpreted as positive, negative, or invalid.

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Binax, Inc. Binax, Inc.
Binax NOW™ Legionella Urinary Antigen Test 510(k) Notification

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)

# PERFORMANCE CHARACTERISTICS

# BINAX NOW™ LEGIONELLA URINARY ANTIGEN TEST

## Preliminary Stability:

Preliminary stability studies of the Binax NOW™ Legionella Urinary Antigen Test are ongoing.

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Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# AUG 21 1998

Pamela S. Angell Program Manager Binax, Inc. 217 Read Street Portland, Maine 04103

K982238 Re:

> Trade Name: Binax NOW™ Legionella Urinary Antigen Test Regulatory Class: II Product Code: MJH Dated: August 12, 1998 Received: August 13, 1998

Dear Ms. Angell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Autman

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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Binax, Inc. Binax NOW™ Legionella Urinary Antigen Test 510(k) Notification

#### APPENDIX B

### INDICATIONS FOR USE FORM

510 (k) Number (if known) :

K 98 2238

Device Name:

Binax NOW™ Legionella Urinary Antigen Test

Indications For Use:

The Binax NOW™ Legionella Urinary Antigen Test is a rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in human urine as an adjunct to culture for the presumptive diagnosis of Legionnaires' Disease. It is intended for in vitro diagnostic use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K982738

Prescription Use (Per 21 CFR 801.109

Over-The-Counter Use OR

(Optional Format 1-2-96)