BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML

{0}------------------------------------------------ ### 510(k) SUMMARY | SUBMITTED BY: | Becton, Dickinson and Company<br>7 Loveton Circle<br>Sparks, MD 21152<br>Phone: 410-316-4287<br>Fax: 410-316-4499 | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT NAME: | Monica Evelyn Giguere,<br>RA Specialist | | DATE PREPARED: | April 5, 2005 | | DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -<br>Tetracycline 0.0625-16 µg/mL | | DEVICE COMMON NAME: | Antimicrobial susceptibility test system-short incubation | | DEVICE CLASSIFICATION: | Fully Automated Short-Term Incubation Cycle Antimicrobial<br>Susceptibility Device, 21 CFR 866.1645 | | PREDICATE DEVICES: | VITEK® System (PMA No. N50510) and BD Phoenix™<br>Automated Microbiology System with Gatifloxacin (K020321,<br>May 23, 2002), Ofloxacin (K020323, April 14, 2002), and<br>Levofloxacin (K020322, March 27, 2002). | | INTENDED USE: | The BD Phoenix™ Automated Microbiology System is<br>intended for the rapid identification and in vitro antimicrobial<br>susceptibility testing of isolates from pure culture of most<br>aerobic and facultative anaerobic Gram-negative and Gram-<br>positive bacteria of human origin. | ### DEVICE DESCRIPTION: The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. For testing Streptococcus species the system includes the following components: - BD Phoenix instrument and software. . - BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents . or AST determinations. - BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. . - BD Phoenix AST-S Broth used for performing AST tests only. ● - BD Phoenix AST-S Indicator solution added to the AST Broth to aid in bacterial growth . determination. {1}------------------------------------------------ The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and veliminarily identified as a Gram-negative or Gram-positive isolate. For each isolate, an inoculation equivalent to a 0.5 McFarland standard is prepared in Phoenix ID broth. The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. Mercurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations. The instrument houses the panels where they are continuously incubated at a nominal temperature of 35°C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, R or N (susceptible, intermediate, resistant or not susceptible). ### DEVICE COMPARISON: The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the CLSI reference broth microdilution method. This premarket notification provides data supporting the use of the BD Phoenix™ Automated Microbiology System Streptococcus ID/AST or AST only Phoenix panels with this antimicrobial agent. ### SUMMARY OF SUBSTANTIAL EQUIVALENCE TESTING: The BD Phoenix™ Automated Microbiology System has demonstrated substantially equivalent performance when compared to the CLSI reference broth microdilution method (AST panels prepared according to NCCLS M7). The system has been evaluated as defined in the FDA Draft guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003. ### Site Reproducibility Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was evaluated at three sites using a panel of streptococal isolates. Each site tested the isolates in triplicate on three different days using one lot of Streptococcus Phoenix panels containing this antimicrobial agent and associated reagents. The results of the study demonstrate for the this antimicrobial agent there was an overall intra-site reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the streptococcal isolates tested. {2}------------------------------------------------ ### Clinical Studies Clinical, stock and challenge isolates were tested across multiple geographically diverse sites across Onlival, extransmate the performance of the Phoenix antimicrobial susceptibility test with the Streptococcus Phoenix Panel format containing this antimicrobial agent. Phoenix System results for Challenge set isolates were compared to the expected results. Phoenix System results for clinical isolates were compared to the results obtained from the CLSI reference broth microdilution method. The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and Category Agreement (CA) to expected/reference results for all isolates tested. Essential Agreement (EA) occurs when the BD Phoenix™ Automated Microbiology System agrees exactly or within ± one two-fold dilution to the reference result. Category Agreement (CA) occurs when the BD Phoenix™ Automated Microbiology System agrees with the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, resistant or nonsusceptible). Table 1 summarizes the performance for the isolates tested in this study. #### Performance of BD Phoenix System for Streptococcal Organisms by Drug Table 1: | The deliver been and commend on and Table<br>A STATE AND LATER AND A LETT A LETT COLLECTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION O<br>Antimicrobial | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>and and a second and supportunities which and the same<br>Concentration | the submit of the same of the same the mail the mail the maint of the maint of the maint of the maint of the maint of the maint of the maint of the maint of the mail of the m<br>CA<br>( m | STATUTE POSSIVE PERSONAL ASL N. N. NOT FOR LT . PLANE OF L. PLANE OF<br>10/0 .<br>15 1<br>1, A | A Comments of Concession CONCRECT COLLA COLLEGE<br>ไ<br>CA (n<br>177 | ( 1 ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1<br>10/01<br>and the state of the same of the different of the different of | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | And The Frances of Children Comments of Children<br>Company Controlled College Compression a no and more and an and any and any and<br>Tetracycline | A<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>0.0625<br>11/2/19/10/11/11/1 | A<br>1 268<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 05 7<br>a a a bood | 1 268 | 07<br>The Tall Tarres We The Page Accelly-divide Advisor | ### Conclusions Drawn from Substantial Equivalence Studies The data collected from the substantial equivalence studies demonstrate that testing on the BD Phoenix™ Automated Microbiology System with this antimicrobial agent is substantially equivalent as outlined in the FDA draft guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003. Technological characteristics of this system are substantially equivalent to those used in the VITEK® system, which received approval by the FDA under PMA number N50510 and BD Phoenix™ Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002). {3}------------------------------------------------ : ## SUMMARY INFORMATION FOR TETRACYCLINE Available Range 0.0625-16 µg/mL ### Performance Accuracy | The first of the country of the country of the county of the county of the county of the county of the county of the county of the county of the county of the county of the c<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>-------------------------------------------<br>Antimicrobial | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>come count an oth Actually por-<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Concentration | Comments of the Comments of Children of Children and Children and Children and Children and Children and Children Children<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>EA (n)<br>TY TH Y L And Collection of the<br>No. of Cattle College of<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>(0/0)<br>" EA .<br>The Real and Children and the | THE LAND AND AND MICH CHICA CART AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND A<br>The Children<br>CA (n)<br>THE TEX LIFERANT<br>A The Callery of Children the States of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s | For War Wall Comment of the comments of<br>CA .<br>(%)<br>and the the hall hand has he in | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Tetracycline | And and and a second and the comments of the control of<br>STATUTE AND AND AND AND A PROPERTY OF IT THE<br>' 0.0625-16 ug/mL<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1 268 | 05 7<br>1 - 1 love | 1 568 | 078<br>.0 | ### Reproducibility Testing performed at multiple clinical sites demonstrated 95% reproducibility or greater within ± 1 dilution. ### Breakpoints - CLSI , FDA | Organism | S | I | R | |-----------------------------------------------------------|----|---|----| | Streptococcus pneumoniae | ≤2 | 4 | ≥8 | | Streptococcus spp. Other than<br>Streptococcus pneumoniae | ≤2 | 4 | ≥8 | ### Recommended Quality Control Organisms | Quality Control Strain | MIC Range | Source | |--------------------------------------------|------------|--------| | <i>Streptococcus pneumoniae</i> ATCC 49619 | 0.12 – 0.5 | CLSI | {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. Public Health Service MAY 1 2 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Monica E. Giguere Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 k050881 Re: K050001 Trade/Device Name: BD Phoenix™ Automated Microbiology System Tetracycline (0.0625-16 µg/mL) - Streptococcus ID/AST or AST only Phoenix Panels Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system Regulatory Class: Class II Product Code: LON Dated: April 5, 2005 Dear Ms. Giguere: Received: April 7, 2005 We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrebute) 70 ttg=227 1976, the Medical Device Amendments, or to connine.co pror to may 2017 2017 11:12 provisions of the Federal Food, Drug, devices mat have been recuire in avere 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, merceroro, mance are act include requirements for annual registration, listing of general controls pro firstiving 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), If your device is elassified (boo aco v) trols. Existing major regulations affecting your device it may be subject to Satin additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 can be found in Ther announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oc advisou that I Drivian that your device complies with other requirements of the Act that IDA has made a deceminations administered by other Federal agencies. You must of any I cach sutures and regulations and limited to: registration and listing (21 Comply with an the Free S require.nemans, 01 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {5}------------------------------------------------ #### Page 2 - This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anon you to cognifinding of substantial equivalence of your device to a legally premarket notification: "The sults 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, If you destre spotition and advertising of your device, please contact the Office of In of quotions on 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 I va may obtain other generers, 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, Sales, a Form 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 {6}------------------------------------------------ Page 1_of 1 510(k) Number: _ Ko50 881 Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Dovice Name: "DD 11 0 p/mL) - Streptococcus ID/AST or AST only Phoenix Panels. Indications for Use: The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of 1116 DD Friotial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and animicrobial Susceptionity by innumal inforce , Uture for Enterobacteriaceae and Non-Enterobacteriaceae laculant vo anaoroosi bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus. This premarket notification is for the addition of the antimicrobial agent tetracycline at concentrations of I fills promation of to the assist only Phoenix panels. Tetracycline has been shown to be 0.0025 - 10.011111 to brepoodess 127 is 2019 as described in the FDA-approved package insert for this antimicrobial agent. ### Active In Vitro and in Clinical Infections Against: Streptococcus species, including S. pneumoniae. Prescription Use V (Per 21 CFR 801.109) Over-the-Counter Use # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Luddiette Poole Division Sign-Off Prescription Use (Per 21 CFR 801.109) Office of In Vitro Diagnostic Device Evaluation and Safety Over-the-Counter Use 510(k) K050881