BD VIPER SYSTEM

{0}------------------------------------------------ # 510(k) SUMMARY | SUBMITTED BY: | BECTON, DICKINSON AND COMPANY<br>7 LOVETON CIRCLE<br>SPARKS, MD 21152 | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT NAME: | Colleen A. Kistler | | TELEPHONE: | 410-316-4988 | | PREPARED: | September 8, 2005 | | DEVICE NAME: | BD ProbeTec™ ET Chlamydia trachomatis and<br>Neisseria gonorrhoeae Amplified DNA Assays | | | BD Viper™ System | | PREDICATE DEVICES: | BD ProbeTec™ ET System as cleared with the BD<br>ProbeTec™ ET Chlamydia trachomatis and<br>Neisseria gonorrhoeae Amplified DNA Assays<br>(K984631) | | | BD Viper™ Instrument (K023955) | ## INTENDED USE: The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Annumbed Driver List in List of the direct, qualitative detect, qualitative detection of Displacement inspiritional Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. il denomans, ... gonorrhoemay be from symptomatic or asymptomatic females and males. generate Amplification Control is an option for inhibition testing (BD ProbeTec ET A separato Ampilliedaton Solla ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper instrument. The BD Viper System, when used with BD ProbeTec™ ET amplified nucleic assay(s) is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent package insert(s). ( {1}------------------------------------------------ # DEVICE DESCRIPTION: The BD ProbeTec ET CT/GC Amplified DNA Assays utilize homogeneous SDA technology as the amplification method and fluorescent energy transfer (ET) as the detection method to test for the presence of CT and GC DNA in clinical specimens. The BD Viper System is comprised of a standalone lysing heater and a BD Viper Instrument. The BD Viper Instrument is comprised of five major subsystems: robotic pipetting arm, priming and warming heaters (two sets), liquid crystal display (LCD) monitor with touch screen, instrument software and two thermally controlled fluorescent readers. # SUBSTANTIAL EQUIVALENCE: This Special 510(k) is submitted for modifications to the subsystems previously cleared with the BD ProbeTec ET System (K984631) and the BD Viper Instrument (K023955). The BD Viper System is comprised of a standalone lysing heater and a BD Viper Instrument that combines the thermal, pipetting and optical subsystems from the previously cleared devices. Thus, there is no technology or intended use change associated with the device modification. Modifications to the subsystems previously cleared with the BD ProbeTec ET System and BD Viper Instrument are as follows: | Modification | Potential Impact of Modification | |----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------| | Incorporated upgraded robot arm and<br>controller | Hardware, Pipettor, Software | | Lysing Heater and Lysing Rack dimensions<br>modified to accommodate tube spacing on<br>the BD Viper Instrument | Hardware, Thermal. Clinical Performance | | Two BD ProbeTec ET thermally controlled<br>optical reader assemblies repackaged and<br>incorporated into the BD Viper Instrument | Hardware, Optics, Thermal, Software,<br>Clinical Performance | | Single function warming heater replaced<br>with a dual-function reader subsystem | Hardware, Thermal, Software, Clinical<br>Performance | | Processing/Workflow Modifications | Pipettor, Hardware, Software, Clinical<br>Performance | | User Software Modifications | Software | The risk analysis did not identify these changes as raising new issues of safety and effectiveness. The parameters listed below were evaluated in studies comparing the BD Viper System to the BD ProbeTec ET System or to expected results (spiked specimen studies). The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays were used to evaluate clinical performance. The BD Viper System met acceptance criteria for all parameters. {2}------------------------------------------------ | Parameter | Result | |------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Lysing Heater | The BD Viper System met operating<br>specifications across various environmental<br>conditions. | | Optical Linearity | The BD Viper System met optical and<br>linearity specifications. | | Hardware Environmental | The BD Viper System met thermal,<br>pipetting, and optical specifications across<br>various environmental conditions. | | Instrument Contamination | The BD Viper System met specifications<br>with regard to control and experimental<br>conditions. | | System Environmental | The BD Viper System met expected results<br>with BD ProbeTec ET CT/GC controls<br>(i.e., positive, negative) across various<br>environmental conditions. | | Analytical Limit of Detection (Diluent) | The BD Viper System had an equivalent<br>analytical limit of detection to the BD<br>ProbeTec ET System for both the BD<br>ProbeTec ET CT and GC assays in a clean<br>system matrix (i.e., BD ProbeTec ET<br>diluent). | | Precision | The precision of the BD Viper instrument<br>was established and met expected results<br>(i.e. positive, negative) for the BD<br>ProbeTec ET CT/GC assays. | | Analytical Limit of Detection (Clinical<br>Matrices) | The BD Viper System had an equivalent<br>analytical limit of detection to the BD<br>ProbeTec ET System for both BD<br>ProbeTec ET CT/GC assays in clinical<br>matrices. | | Individual Spiked Specimen | The BD Viper System met expected results<br>(i.e., positive, negative) for the BD<br>ProbeTec ET CT/GC assays. | | Clinical Agreement | The BD ProbeTec ET CT/GC assay<br>performance was equivalent between the<br>BD Viper System and the BD ProbeTec ET<br>System. | : . {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting the health and well-being of the nation. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 NOV 2 5 2005 Ms. Colleen A Kistler Regulatory Affairs Specialist BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Re: k052481 Trade/Device Name: BD Viper™ System Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL Dated: November 15, 2005 Received: November 16, 2005 Dear Ms. Kistler: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the endrosals) to ttgrains and ment date of the Medical Device Amendments, or to conninered pror co rize) 2011-12-11 accordance with the provisions of the Federal Food, Drug, de nees that have occir rout 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 I ou may, therefore, mains 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 that + Dr haral statutes and regulations administered by other Federal agencies. You must or any I 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). {4}------------------------------------------------ #### Page 2 - 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 predicated 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, rr you stions on the promotion and advertising of your device, please contact the Office of In of quotions of the prom Evaluation and Safety at (240)276-0484. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html Sincerely yours, Sale, a Story 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 {5}------------------------------------------------ ### Indications for Use 510(k) Number (if known): Kosa481 Device Name: BD ProbeTec™ ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays BD Viper™ System ### Indications For Use: The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoege. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper instrument. The BD Viper System, when used with BD ProbeTec™ ET amplified nucleic acid assays, is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent package insert(s). Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Allie Sati **Division Sign-Off** Page 1 of 1 BD Diagnostic Systems Becton, Dickinson and Company Office of In Vitro Diagnostic Device 510(k) K052481