BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI

{0}------------------------------------------------ K991726 5/11/99 Revision Dinax, Inc. Binax NOW® Streptococcus pneumoniae Urinary Antigen Test 510(k) Notification ### 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS )AUG 27 1999 Binax NOW Streptococcus pneumoniae 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 > Attention: Pamela S. Angell (207) 772-3988 (Office) (207) 871-5751 (FAX) pangell@binax.com (email) Binax NOW" Streptococcus pneumoniae Urinary Trade Name: Antigen Test Strep pneumo ICT, Binax NOW® Strep pneumo Common Name : test - Classification Name: Streptococcus spp. serological reagents (per 21 CFR 8660.3740) Wellcogen Bacterial Antigen Kit, 510(k) Predicate Device: number K854852 - Binax Now Streptococcus pneumoniae Device Description: The Antigen Test is ਤੇ ਸ Ilrinary immunochromatographic membrane assay used to pneumoniae (S. Streptococcus detect pneumoniae) antigen in human urine. A test containing gold-conjugated and strip, immobilized anti-S. pneumoniae antibodies, and a swab well are mounted on opposite sides of a cardboard, book-shaped hinged test device. A 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 device. Pneumococcal the test closing antigen present in the urine sample reacts bind anti-S. pneumoniae conjugated to antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-S. pneumoniae antibody, forming the Sample Line. Immobilized goat anti-rabbit IgG captures excess visualizing conjugate, forming the Control Line. {1}------------------------------------------------ ### SUMMARY OF SAFETY AND EFFECTIVENESS 510 (k) (Continued) There are no transferring steps, the sample contained, and results are available is within 15 minutes. NOW® Streptococcus pneumoniae Binax Intended Use: The Urinary Antigen Test is an in vitro rapid immunochromatographic assay for the detection of S. pneumoniae antigen in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of pneumococcal pneumonia in conjunction with culture and other methods. Both the Binax NOW® Streptococcus Technological pneumoniae Urinary Antigen and the Wellcogen Characteristics : Bacterial Antigen Tests are simple rapid tests with a visual result interpretation. Both use a solid phase coated with polyclonal antibody to detect S. pneumoniae antigen in human urine samples. However, the predicate device is a latex agglutination test employing antibody coated polystyrene beads that agglutinate in the presence of The Binax sufficient homologous antigen. Streptococcus pneumoniae Urinary NOW® Antigen Test is an immunochromatographic assay utilizing a colloidal gold conjugate and an antibody striped membrane to capture and visualize antigen. Binax NOW® Streptococcus pneumoniae Performance Summary: The Urinary Antigen Test is substantially equivalent to the predicate device, the Wellcogen Bacterial Antigen Test (K854852), for the detection of S. pneumoniae urinary The performance of the Binax NOW antigen. Streptococcus pneumoniae Urinary Antigen Test was verified using freshly collected and characterized frozen urine specimens. PERFORMANCE attached to Refer CHARACTERISTICS . Signed J. George Nitis Date 5/19/99. J. Georges Nitis, Ph.D., MBA Director, Regulatory Affairs {2}------------------------------------------------ Binax, Inc. Binax NOW® Streptococcus pneumoniae Urinary Antigen Test 510(k) Notification ## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued) ## PERFORMANCE CHARACTERISTICS BINAX NOW" STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST #### Analytic Sensitivity: Twenty-three (23) of 83 known Streptococcus pneumoniae serotypes are responsible for at least 90% of serious pneumococcal infection worldwide. I Forty-four (44) isolates representing these 23 serotypes and one additional serotype were grown in culture and assayed in the Binax NOW test at a concentration of 10° organisms/mL. One hundred percent (100%) were positive, indicating that the Binax NOW test detects the most pathogenic S. pneumoniae serotypes. ### Analytic Specificity (Cross-Reactivity) : To demonstrate the immunologic specificity of the Binax NOW test, 144 potential cross-reactants were grown in culture and tested in the Binax NOW® test. The cross-reactant panel included organisms associated with pneumonia as well as those likely to be found in the urogenital tract as normal flora or as a result of urinary The Binax NOW test does not cross-react with 143 tract infection. of the 144 organisms when tested at concentrations of 10° to 10° The single positive organism, Streptococcus mitis, is an CFU/mL. expected cross-reactant as is shares the antigen against which the Binax NOW test is directed. Streptococcus mitis is associated with endocarditis, not pneumonia, and is not likely to appear with any frequency in the population intended to be tested with the NOW test.la #### Clinical Sensitivity and Specificity: The Binax NOW Streptococcus pneumoniae Urinary Antigen Test was evaluated in both prospective and retrospective clinical studies. In the retrospective study, 35 urine specimens from blood culture positive pneumococcal pneumonia patients and 338 urine specimens from presumed S. pneumoniae negative patients were evaluated in the NOW test. Of the presumed negative urines, 28 were collected from bacteremic patients, 4 from patients with empyema, 53 from patients with pneumonia, 153 from patients with urinary tract infections, and 100 from patients with no known infection. Binax NOW test performance, calculated using standard methods, was 86% sensitivity, 94% specificity, and 93% overall accuracy. Ninetyfive percent (95%) confidence intervals are listed below. ¹ Refer to Product Insert reference number 9. la Howard, B.J., Clinical & Pathogenic Microbiology, 200 ed. 1994. Mosby-Year Book Inc., St. Louis, MO., pg 267. {3}------------------------------------------------ ### SUMMARY OF SAFETY AND EFFECTIVENESS 510 (k) PERFORMANCE CHARACTERISTICS (Continued) BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST | | | Blood Culture | | |----------------|---|---------------|-----------------| | | | + | - | | NOW®<br>Result | + | 30 | 21 | | | - | 5 | 317 | | Sensitivity | | = 86% | (70.9% - 93.9%) | | Specificity | | = 94% | (90.9% - 96.0%) | | Accuracy | | = 93% | (89.9% - 95.1%) | In a separate multi-center prospective study, 215 urine specimens t and the colornitalized or out-patients presenting with lower In a separate multi-center prospective scady razont with lower from either hospitalized or out-patients presenting with lower from either nospitalized respiratory symptoms or sepsis and result in the Now test. suspected of pneumococal pneumon was collected within 24 hours of The confirmatory blood specimen was collected within 24 hours of Now test performance versus the conrinuation, and then cultured. standard methods, was 90% ne Sample ample and using re, calculated fusing Standard accuracy. Ninety 76% specificity, and 78% overall accuracy. blood sensitivity, sensitivity, 76% specificity, and 450-ar-listed below. five percent (95%) confidence intervals are listed below. | | | Blood Culture | | |----------------|---|---------------------|-----| | | | + | - | | NOW®<br>Result | + | 28 | 45 | | | - | 3 | 135 | | Sensitivity | = | 90% (74.6% - 96.4%) | | | Specificity | = | 75% (69.3% - 81.5%) | | | Accuracy | = | 77% (71.9% - 83.0%) | | ## Interfering Substances: Interfering Substances: found not to cross-react with potentially Nineteen (19) urine The Binax Now test was reasons in urine. interfering substances present of white blo interfering substances present in urne. Innovous of and blood specimens with elevated levels of urines with high turbidity, and cells, protein, and/or gilcose, 3 triles warameters were 5 urines normal with respect to each of act (20) specimens were the Binax NOW test. Twenty-eight (20) specimen with negative. The single invalid Cest, products by Self elevated red blood cells, could not be interpreted due to the negative. elevated Ted brood Coller, extreme coloration of the test membrane. ## Pneumococcal Vaccine: ﻤﺴﺎﻫﻤﺎﺕ Pheumococcal Vaccine on Binax NOW test performance impact of S. pheumoniae vaccine on blick home of the more of the the Lederle Pnu-Immune® was 23 before and after immunization with d atter immunization with the golive in the Binax NOW" All study participants tested negative in the Binax positive vaccine. vaccine. All study participants cessed nogation of the tested positive test before vaccination. Thirten percent (133) tested negative test before vaccination. Thirtcen possour in within 30 hours of being vaccinated, but again tested negative 6 - 4 {4}------------------------------------------------ Binax, Inc. Binax Now® Streptococcus pneumoniae Urinary Antigen Test 10(k) Notification # 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS # PERFORMANCE CHARACTERISTICS (Continued) BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST within 48 hours of vaccination. Binax NGW test product labeling within 48 hours of Vaccination. " Binax Now " " " " " " " " " " " " " " " " " " false positive results in the Binax NOW® test in the 48 hours false positive results in the binnended that the Binax NOW" test following varchhatlon. Te is receiving the S. pneumoniae vaccine. ### Reproducibility : Reproductibility. A blind study of the Binax NOW test was conducted at 3 separate A blind study of the Binax Row couraning negative, low sites using a panel of coded specialism positive urine controls. positive, moderate positive and 2 different ave 99 4% of the positive, moderate posicive and ligh poent days. 99.4% of the Farcicipants porrolmed and correctly interpreted. ### Quality Control: - The ability of the Binax NOW® Test procedural control to indicate test failure was evaluated when 3 operators each rain 200 kit test failure was evaluated which 5 openatib had been rendered controls in a panel of 20 oevices of defective and the defect itself were not apparent to the operator. Increase of the more in the itself were not apparent to the opensive, negative, negative, or invalid. ## Preliminary Stability: Preliminary Stability studies of the Binax NOW Streptococcus Preliminary Stability Studics of Chicals are ongoiny. Tost pneumoniae Urinary Antigen Test and kit controls are ongoiny. Cleared ICT pheumoniae Urinary Ancigen Itso and Sinax 510 (k) cleared ICT results are consistent with other is sticipated results are consistent with 6 - 5 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 AUG 27 1999 Ms. Pamela S. Angell Program Manager Binax, Inc. 217 Read Street Portland, Maine 04103 Re: K991726 K991726 Trade Name: Binax Now® Streptococcus pneumoniae Urinary Antigen Test Regulatory Class: II Product Code: GTZ Dated: August 18, 1999 Received: August 23, 1999 Dear Ms. Angell: We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 510(x) notifically equivalent (for the indications for use above and we have determined the device is subscribes marketed in interstate commerce stated in the enclosure) to legally marketed prodical of Desice Amendments, or to device stated in the enclosure) to legally marked predice in the Medice Amendments, or to devices that prior to May 28, 1976, the enactment date of the Medical Food Drug, and prior to May 28, 1970, the enactinen date of the Federal Food, Drug, and have been reclassified in accordance with the provisions of as been to the general controls Cosmetic Act (Act). You may, therefore, market the Action Actively requirements f Cosmetic Act (Act). You may, merciors, mance include requirements for annual provisions of the Act. "The general controls provisions of an and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into cities in controls. Existing major regulations (Premarket Approval), it may be subject to sateral Regulations, Title 21, Parts 800 to 895. affecting your device can be found in the Code of Federal Regulations Current Good affecting your device can be louid in the essumes compliance with the Current Good A substantially equivalent detemmination asset forth in the Quality System Regulation (OS) for Manufacturing Practice requirements, as set forth in the Quality System Regula Manufacturing Practice requirements, as the rear 820) and that, through periodic QS Medical Devices: General regulation (21 CFR Part & exchange with answers and Medical Devices: General regulation (2) CFR Part Party such assumptions. Failure to inspections, the Food and Drug Administration (FDA) will sectify such assumptions, EDA inspections, the Food and Drug Aummistration in addition, FDA may publish comply with the GMP regulation may result in regulation, Places note: this comply with the GMF Tegulation may result in the Federal Register. Please note: this further announcements concerning your doves not affect any obligation you might response to your premarket notification submission the Electronic Product response to your premarker notheaton submission ave es under the Electronic Product nave under sections 551 through b 12 cFederal laws or regulations. {6}------------------------------------------------ ## Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLA-88), this device may out of the may of the may in the minerified does, wou should contact the Under the Ciffical Laboratory improveinon. To determine if it does, you should contact the require a CLIA Complexity Sategorized on (CDC) at (770) 488-7655. This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begil nialiscung your device to a legally marketed notification. The FDA finding of substantial equivalence of your device to notification. The ITA Inding of substantial oqur factive of 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 If you desire specific advice for your devices), please contact the Office of Compliance at additionally 809.10 for in vitro diagnostic devices), please contactive of your de additionally 809.10 for m vitto diaguestions on the promotion and advertising of your device, (301) 594-4588. Additionally, for questions of the presses Also, please note the regulation please contact the Office of Comphance at (301) >> Teation"(21 CFR 807.97). Other general entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Oth entitled, "Misbranding by relectlifes under the Act may be obtained from the Division of Small information on your responsibilities under the Act may be obtained from the 100 information on your responsibilities under (800) 638-2041 or (301) 443-6597, or at its Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) - 1 Manufacturers 713515tailoo av fd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sincerely yours, Steven Putman 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 {7}------------------------------------------------ Binax, Inc. Binax, NOW® Streptococcus pneumoniae Urinary Antigen Test Pressure if Contion Binax No" 510(k) Notification ## APPENDIX B # INDICATIONS FOR USE FORM 510(k) **Number (if known):** K991726 Device Name: Binax NOW® Streptococcuss Binax NOW Borep pneumoniae Urinary Antigen Test # Indications For Use: The Binax NOW Streptococcus pneumoniae Urinary Antigen Test The Binax NOW® Streptococcus pneumoniae Orinary on of is a rapid immunochromatographic as an adjunct to Streptococcus pneumoniae in human urine as an adjunct to is a rapid imman urine diagnosis of pneumococcal culture for the presumptive diagnosis of pneumostic use the presumptive diagnosis or presumer ---------------------------------------------------------------------------------------------------------------------------------------pneumonia. PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANCTHER PAGE IF NEDEDED) 45 be Norman ------------------------------------------------------------------------------Division Significal Laboratory Device 510(k) Number Over-The-Counter Use OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)