URINE SCREENING DEVICE

{0}------------------------------------------------ K9726576 COMBACT DIAGNOSTIC SYSTEMS LTD FEB 2 3 1998 # comBact P.O.B. 2222 Herzeliya 46120, Israel Tel. 972-9-561412 Fax. 972-9-585611 ## 510(k) Summary: Substantial Equivalence | • Device name | Bactis 160US | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | • Common name | Urine screening device | | • Classification name | Kit, Screening Urine | | • 510(k) submitter | Combact Diagnostic Systems Ltd.,<br>Medinat Hayehudim 60, P.O.B 2222,<br>Herzliya, Israel 46120.<br>Phone: 972-9-9561412<br>Fax: 972-9-9585611 | | • Device classification | The device is a class I device | | • Predicate Device: | The Bactis 160US is substantially equivalent to the<br>Bac-T-Screen, BioMerieux- Vitek Inc. 1993 (K924218) | #### Intended Use 1.1 The Bactis 160US is an automated, computer assisted, optical imaging system intended for rapid screening analysis of urine samples for presence of bacteria. ### 1.2 Device Description The Bactis 160US is based on direct screening of urine using optical image analysis. Thirty (30) ul of well-mixed urine is mixed with fluorescent stains that bind to bacteria and other particles present in the specimen. The stained samples are filtered through a membrane. The dispersed and stained organisms are excited with a filtered lamp to produce a distinct fluorescent signal. Using fluorescence microscopy and a CCD camera the image of the sample is captured. These microscopic images are then analyzed. Using digitized image processing techniques, the bacteria are localized and enumerated, and their concentration is determined. Bacterial concentration for each specimen can be then reported. Alternatively, the concentration can be compared to a predetermined threshold (according to each laboratory's policy) and each urine sample can be categorized according to the {1}------------------------------------------------ infection category of "positive" or "negative". This method provide results within 25 minutes. The Bactis system is comprised of the following main components: - Control and Data Management System (CMS) 1. - Specimen Processor and Analyzer (SP&A) Unit 2. The urine screening process is controlled and monitored by the operator via the CMS, The CMS is comprised of two PC computers. An optional printer can be used to provide diagnostic reports. In the SP&A Unit, the specimens are processed and analyzed. #### 1.2.1 Functional Description The Bactis 160US testing process is performed as follows: The specimens are identified by a bar-code reader which is connected to the CMS computer (or by manual logging of the specimens' identification parameters into the computer) and loaded in their standard collection containers into a portable tray that can accommodate up to 16 specimens. The portable tray is inserted by the operator into the SP&A unit's Input Station. Aliquots of each sample are automatically dispensed by the robotic arm into special multiwell cassettes. Fluorescent stains are added and the cassette is directed to the filtration station. Each sample is filtered through a membrane, and the liquid is discarded. This process produces a monolayer of homogeneously dispersed and stained organisms. The samples are then directed to the microscopic imaging station where the system detects the presence of organisms. Bacterial concentration is reported for each specimen. ### 1.3 Substantial Equivalence Comparison The intended/indications for use of the Bactis 160 US are similar to other legally marketed types of urine screening devices. The Bactis 160 US is an automated, computer assisted, microscopy system intended for detection and enumeration of bacteria in urine specimens. The device is indicated for use in rapid screening analysis of urine samples to assess the occurrence of bacteriuria. There are several methods or technological applications currently in use for urine screening for detection of bacteriuria. In general, urine screening devices for bacteriuria are based on bacterial growth such as the standard culture, or on direct enumeration of bacteria in urine samples. Both the Bactis 160 US and the legally marketed Bac-T-Screen 2000 (K924218) devices can detect and enumerate bacteria directly in urine samples without first requiring culture of the urine specimen. The technology employed by the Bactis 160 US is similar to the Bac-T-Screen 2000 in that urine samples are filtered and stained with proprietary stains before the enumeration process takes place. However, the Bactis 160 US, unlike the Bac-T-Screen 2000 (which is based on a colorimetric measurement), employs a direct bacterial particle counting technique, which yields accurate and reliable enumeration of bacteria in urine. {2}------------------------------------------------ Table 1 presents the salient similarities and differences of devices/ methods used for urine screening. | | Table 1 Similarities and Differences | | | |-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Comparison Elements | Bactis 160 US | Bac-T-Screen | Standard Culture | | Intended Use | Bacteriuria<br>detection | Bacteriuria/Pyuria<br>detection | Bacteriuria detection | | Requires growth of the<br>organism | No | No | Yes | | Technology/Methodology | Direct bacterial<br>detection and<br>enumeration via<br>fluorescent<br>staining, filtration,<br>and optical imaging | Direct bacterial<br>detection via<br>filtration, staining,<br>colorimetric<br>analysis. | Bacterial growth and<br>enumeration of<br>formed colonies on<br>agar plates. | | Time of analysis | 25 min. | 2 min. | "overnight" | | Threshold of positivity | 105 CFU/ml | 105 CFU | Site established<br>thresholds (104- 105) | | Objective interpretation of<br>results (automated<br>reader/analyzer) | Yes | Yes | Mostly read<br>"manually"<br>Automated colony<br>counters available. | | Automated addition of<br>reagents to sample | Yes | Yes | N/A | | Enumeration | Yes | No | Yes | | Min. vol. of urine required | 1 ml | 1 ml | 0.1 ml | ## 1.4 Performance Comparison Performance data collected during clinical studies conducted at two sites, demonstrated Performance data conected during onlines samples and report bacterial. that the Bactis 160 US can detect bacteria in urine samples and report bacterial that the Bactis 100 OS can delect bacteria in anno senipres. In addition, the clinical studies concentration as well as the standard reference procedures arended culture concentration as well as the standard reference procession's such as expanded culture included a more detailed protocol for assessing bacterium's such inhibitions subs included a more detailed protocor for assessing bacterialia one and interest of growth inhibitory substances in urine, e.g., antimicrobic agents. A total of 4561 random urine specimens were prospectively tested at wo different clinical A total of 4561 random urine specialisms. Appropriate statistical techniques were applied to sites under double billided conditions. Approprities support the comparative safety demonstrate equivalence of methods. The clinical support the methods for detective demonstrate equivalence of methods. The childard reference culture methods for detecting {3}------------------------------------------------ ﺮﻣﺴ . . . bacteriuria. Table 2 presents the (lowest/highest) values of indicators of performance obtained for the Bactis 160 US. | Table 2: Performance data result | | |----------------------------------|--------------| | | Bactis 160US | | Sample size | 4561 | | Threshold CFU/ml | $\ge 10^5$ | | Sensitivity | 87.5 - 90.2% | | Specificity | 75% - 86.7% | | Negative Predictive Value | 96.2 - 97.5% | ## 1.5 Conclusions Based on all the information presented in the 510(k) submission it was concluded that there is both a scientific as well as regulatory basis for determining the Bactis 160 US Substantially Equivalent. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Thomas M. Tsakeris Devices and Diagnostics Consulting Group & U.S. Contact for Combact Diagnostics. Inc. 16809 Briardale Road Rockville, MD 20855 FEB 2 3 1998 Re: K972676 Trade Name: Urine Screening Device Regulatory Class: I Product Code: JXA Dated: November 24, 1997 Received: November 25, 1997 Dear Mr. Tsakeris: 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 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 (OS) 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. {5}------------------------------------------------ #### 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 (770)488-7655. 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 {6}------------------------------------------------ ## 2. Intended Use/ Indication for Use Statement 510(k) Number (if Known) K912676 Device Name: Bactis 160US ## 2.1 Intended Use The Bactis 160US is an automated, computer assisted, optically based in vitro diagnostic . instrument intended for the rapid detection and enumeration of bacteria in urine specimens. Urine samples are stained, filtered through a membrane, and excited with light of a defined wavelength range so as to produce a distinct fluorescent signal. Using fluorescent microscopy and a CCD camera, the image of the sample is captured. Using digitized image processing, the microscopic images are analyzed and the concentration of bacteria prosent -in the specimen is determined by applying a proprietary software algorithm. . . . . . . . . ### 2.2 Indication for Use The Bactis 160US is indicated for rapid urine screening for the purpose of determining the occurrence of bacteriuria. Evidence of bacteriuria is an important factor for clinicians to consider in making a diagnosis of urinary tract infection. Per. Htr 2/23/98 (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K972676 Prescription Use V (Per 21 CFR 801.109) OR Over-The Counter Use (Optional Format 1-2-96)