MICROSCAN SYNERGIES PLUS

{0}------------------------------------------------ K020142 ### 510(k) Summary #### 510(k) Submission Information: | Device Manufacturer: | Dade Behring Inc. | |----------------------|----------------------------------------------------------------------------------------------------| | Contact name: | Maureen Mende, Group Manager Regulatory Affairs | | Fax: | 916-374-3144 | | Date prepared: | January 15, 2002 | | Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels | | Trade Name: | MicroScan® rapID/S plus™ Gram-Negative MIC/Combo panels | | Intended Use: | To determine antimicrobial agent susceptibility | | 510(k) Notification: | Antimicrobials: Ofloxacin, Norfloxacin, Levofloxacin, Lomefloxacin Sparfloxacin, and Ciprofloxacin | | Predicate device: | MicroScan Dried Gram Negative MIC/Combo Panels | #### 510(k) Summary: MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. The MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are read on the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments). The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. The rapID/S plus™ panels are inoculated with a standardized suspension of the organism and incubated at 35℃ in the WalkAway® SI System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth. The proposed MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000. The Premarket Notification (510[k]) presents data in support of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel with Ofloxacin, Levofloxacin, Lomefloxacin, Sparfloxacin, and Ciprofloxacin. The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed rapID/S plus™ Gram-Negative Panel by comparing its performance with an NCCLS frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The rapID/S plus™ Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 98.3% for Offloxacin, 97.4% for Nortloxacin, 98.2% for Levofloxacin, 98.6% for Lomefloxacin, 98.6% for Sparfloxacin and 98.3% for Ciprofloxacin when compared with the frozen Reference panel. Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Offloxacin, Norfloxacin, Levofloxacin, Lomefloxacin, Sparfloxacin, and Ciprofloxacin with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments). Quality Control testing demonstrated acceptable results for Ofloxacin, Levofloxacin, Lomefloxacin, Sparfloxacin, and Ciprofloxacin. {1}------------------------------------------------ ### Section 1. LABELING SUMMARY # Labeling Changes Requiring FDA Clearance Prior to Implementation - Clearance is requested for an MIC range which allows MicroScan the ability to select . any number of antimicrobic for inclusion on future panels. The combination of dily halls chosen will be verified for acceptable performance, as defined in the DRAFT FDA guidance document titled "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000, prior to release. The dilutions requested, for use with gram-negative are indicated below: | Antimicrobial | Panel Type | Abbreviation | MIC Dilutions<br>Requested | |---------------|---------------|--------------|----------------------------| | Ciprofloxacin | gram-negative | Cp | 0.25 – 8 µg/ml | | Levofloxacin | gram-negative | Lvx | 0.5 - 16 µg/ml | | Lomefloxacin | gram-negative | Lmf | 1.0 - 16 µg/ml | | Norfloxacin | gram-negative | Nxn | 0.12 - 32 µg/ml | | Ofloxacin | gram-negative | Ofx | 0.12 - 16 µg/ml | | Sparfloxacin | gram-negative | Sfx | 0.5 - 8 µg/ml | - The following FDA Interpretive Breakpoints will be added to the MicroScan® rapID/S plus™ Procedural Manuals: | Interpretive Breakpoints1 | Antimicrobial Agents | Susceptible | Intermediate | Resistant | |---------------------------|----------------------|-------------|--------------|-----------| | Ciprofloxacin | ≤1 | 2 | ≥4 | | | Levofloxacin2 | ≤2 | 4 | ≥8 | | | Lomefloxacin3 | ≤2 | 4 | ≥8 | | | Norfloxacin3 | ≤4 | 8 | ≥16 | | | Ofloxacin3 | ≤2 | 4 | ≥8 | | | Sparfloxacin4 | ≤1 | 2 | ≥4 | | 1. Based on Interpretive Breakpoints as indicated in NCCLS Document M100-S11. There are antimicrobials included on the rapID/S plus™ panels that are not proven to be effective for treating clinical infections for all organisms that may be tested. For interpreting and reporting of antimicrobial results which have shown to be active against organism groups, tooth in chiro and in clinical infections, refer to NCCLS M100 Performance Standard Table1 or the pharmaceutical antibiotic labeling. antiblotic laboling. 2. Interpretive criteria for urinary tract infections are only for P.aeruginosa and Other Non-Enterobacteriaceae, 3. Interpretive criteria applies to urinary tract infections only. 4. Interpretive criteria applies to Enterobacteriaceae only. {2}------------------------------------------------ - The following Performance Characteristics claims will be added to the Procedural . Manual: | Antimicrobial Agent | Essential Agreement (%) | Categorical Agreement (%) | |---------------------|-------------------------|---------------------------| | Ciprofloxacin | 640/651(98.3) | 604/651 (92.8) | | Levofloxacin | 639/651 (98.2) | 614/651 (94.3) | | Lomefloxacin | 642/651 (98.6) | 618/651 (94.9) | | Norfloxacin | 634/651 (97.4) | 609/651 (93.5) | | Ofloxacin | 640/651 (98.3) | 609/651 (93.5) | | Sparfloxacin | 561/569 (98.6) | 548/569 (96.3) | ### Percent Agreement to Reference Method - The following QC ranges will be added to the Quality Control Manual: . | Antimicrobial<br>Agent | Abbreviation | <i>E. coli</i><br>ATCC 25922<br>Range1 | <i>P. aeruginosa</i><br>ATCC 27853<br>Range1 | |------------------------|--------------|----------------------------------------|----------------------------------------------| | Ciprofloxacin | Cp | <= 0.25 | <= 0.25-1 | | Levofloxacin | Lvx | <= 0.5 | <=0.5-4 | | Lomefloxacin | Lmf | <= 1.0 | <=1-4 | | Norfloxacin | Nxn | <= 0.12 | 1-4 | | Ofloxacin | Ofl | <= 0.12 | 1-82 | | Sparfloxacin | Sfx | <= 0.5 | <=0.5-23 | Range = Expected value (µg/ml) 1. Out-of-range results may require extended incubation and reporting may range from 16-20 hours. 2. Organism intended for Quality Control Testing only. 3. - The following limitations will be added to the Limitations Section of the MicroScan® . rapID/S plus™ Gram-Negative Procedural Manual: - For Ofloxacin confirm and report Pseudomonas aeruginosa results at 16-20 hours . incubation. {3}------------------------------------------------ MicroScan rapID/S plus" Gram - Negative Procedural Manual . Oflox Norflox Levo Lomeflox Sparflox Cipro labeling summary.doc.doc 17 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 SEP 1 4 2004 Mr. Robert Eusebio Manager Regulatory Affairs Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691 Re: k020142 Trade/Device Name: MicroScan® Synergies Plus Gram Negative MIC/Combo Panels with Ofloxacin, (0.12-16 ug/ml), Norfloxacin (0.12-32 ug/ml), Levofloxacin (0.5-16 µg/ml), Lomefloxacin (1.0-16 µg/ml), Sparfloxacin (0.5-8 µg/ml), Ciprofloxacin (0.25-8 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: February 13, 2002 Received: February 15, 2002 Dear Mr. Eusebio: This letter corrects our substantially equivalent letter of March 14, 2002, regarding the trade name which was changed to MicroScan® Synergies Plus to better reflect the intended use of the device. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {5}------------------------------------------------ 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to continue marketing your device as described in your Section 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 Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-3084. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, 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}------------------------------------------------ # Indications for Use Statement #### 510(k) Number (if known): K020142 Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Offloxacin, (0.12 -- 16 µg/ml), Norfloxacin (0.12 - 32 µg/ml), Levofloxacin (0.5 - 16 µg/ml), Lomefloxacin (1.0 - 16 ug/ml), Sparfloxacin (0.5 - 8 ug/ml), Ciprofloxacin (0.25 - 8 ug/ml) #### Indications For Use: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic Gram-Negative bacilli (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® S/ System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert. This particular submission is for the antimicrobials Ofloxacin, Norfloxacin, Levofloxacin, Lomefloxacin, Sparfloxacin, and Ciprofloxacin on the Synergies plus" Gram-Negative MIC/Combo Panels. The Gram-Negative organisms which may be used for Ofloxacin (Ofl), Norfloxacin (Nxn), Levofloxacin (Lvx), Lomefloxacin (Lmf), Sparfloxacin (Sfx), and Ciprofloxacin (Cp) susceptibility testing in this panel are listed in the attached table. Prescription Use __ X (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) Page 1 of 1 {7}------------------------------------------------ # INDICATIONS FOR USE STATEMENT Page 2 of 3 . 510(k) Number (if known): K_ Device Name: MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels with Ofloxacin, (0.12 - 16 ug/ml), Norfloxacin (0.12 - 32 µg/ml), Levofloxacin (0.5 - 16 µg/ml), Lomefloxacin (1.0-16 ug/ml), Sparfloxacin (0.5 - 8 µg/ml), Ciprofloxacin (0.25 - 8 µg/ml ### Indications For Use: | Organism | Cp | Lvx | Lmf | Nxn | Ofn | Sfx | |-------------------------------|----|-----|-----|-----|-----|-----| | Acinetobacter baumanii | | X | | | | X | | Acinetobacter calcoaceticus | | X | | X | X | | | Acinetobacter Iwoffi | X | X | | | | X | | Aeromonas caviae | X | | | | X | | | Aeromonas hydrophila | X | | X | | X | | | Aeromonas spp | | | | X | | | | Alcaligenes spp | | | | X | | | | Citrobacter koseri (diversus) | X | X | | X | X | X | | Citrobacter freundii | X | X | X | X | X | | | Edwardsiella tarda | X | | | X | | | | Escherichia coli | X | X | X | X | X | | | Enterobacter aerogenes | | X | X | X | X | X | | Enterobacter agglomerans | | X | X | | | | | Enterobacter cloacae | X | X | X | X | X | X | | Enterobacter sakazakii | | X | | | | | | Flavobacterium spp | | | | X | | | | Hafnia alvei | | | X | X | | | | Klebsiella oxytoca | X | X | X | X | X | X | | Klebsiella ozaenae | | | X | | | | | Klebsiella pneumoniae | X | X | X | X | X | X | | Klebsiella rhinoscleromatis | | | | X | | | | Morganella morganii | X | X | X | X | X | X | | Pasteurella multocida | X | | | | | | | Proteus mirabilis | X | X | X | X | X | X | | Proteus vulgaris | X | X | X | X | X | X | ### ORGANISMS INTENDED FOR TESTING (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR (Optional Format 1-2-96) Oflox Norflox Levo Lomeflox Sparflox Cipro 510k rev1a.doc. 12 {8}------------------------------------------------ # INDICATIONS FOR USE STATEMENT Page _ 3_of_ 3_ 510(k) Number (if known): K_ MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels with Ofloxacin, (0.12 - 16 Device Name: ug/ml), Norfloxacin (0.12 - 32 µg/ml), Levofloxacin (0.5 - 16 µg/ml), Lomefloxacin (1.0 - 16 µg/ml), Sparfloxacin (0.5 - 8 µg/ml), Ciprofloxacin (0.25 - 8 µg/ml) # Indications For Use: | Organism | Cp | Lvx | Lmf | Nxn | Ofl | Sfx | |---------------------------|----|-----|-----|-----|-----|-----| | Providencia alcalifaciens | | | X | X | | | | Providencia rettgeri | X | X | X | X | X | | | Providencia stuartii | X | X | X | X | X | | | Pseudomonas aeruginosa | X | X | X | X | X | | | Pseudomonas fluorescens | | X | | | | | | Serratia liquefaciens | | | X | | | | | Serratia marcescens | X | X | X | X | X | | | Shigella boydii | X | | | | | | | Shigella dysenteriae | X | | | | | | | Shigella flexneri | X | | | | | | | Shigella sonnei | X | | | | | | | Shigella spp | | | | X | | | | Salmonella enteriditis | X | | | | | | | Salmonella spp | | | | X | | | | Salmonella typhi | X | | | | | | | Yersinia enterocolitica | X | | | X | | | | Vibrio cholerae | X | | | X | | | | Vibrio parahaemolyticus | X | X | | X | X | | | Vibrio vulnificus | X | | | | | | # ORGANISMS INTENDED FOR TESING (cont.) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_X (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR (Optional Format 1-2-96) Oflox Norflox Levo Lomeflox Sparflox Cipro 510k rev1a.doc. 13