← Product Code [JWY](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY) · K061687 # MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS (K061687) _Dade Behring, Inc. · JWY · Jul 21, 2006 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY/K061687 ## Device Facts - **Applicant:** Dade Behring, Inc. - **Product Code:** [JWY](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY.md) - **Decision Date:** Jul 21, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.1640 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for Use The MicroScan® Dried Gram Negative Panel is designed for use in the Confirmation of Extended-Spectrum Beta-Lactamase (ESBL) production in Escherichia coli, Klebsiella spp. and Proteus mirabilis. After inoculation, panels are incubated for 16-20 hours at 35°C +/- 1°C in a non-CO2 incubator and read either visually or with MicroScan® instrumentation, according to the Package Insert. This particular submission is for the use of cefotaxime (2, 16 µg/ml), cefotaxime/clavulanic acid (0.5/4, 4/4 µg/ml), ceftazidime (1, 8 µg/ml) and ceftazidime/clavulanic acid (0.25/4, 2/4 µg/ml) for ESBL confirmatory testing on MicroScan® Dried Gram Negative MIC/Combo Panels and the addition of automated read methods. The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are: Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis ## Device Story MicroScan® Dried Gram-Negative MIC/Combo Panels utilize dehydrated microdilutions of antimicrobial agents in Mueller Hinton Broth; panels rehydrated and inoculated with bacterial suspension (turbidity or Prompt® method); incubated 16-20 hours at 35°C in non-CO2 environment; growth visually observed or measured by autoSCAN®-4 or WalkAway® systems; device confirms ESBL production by comparing growth inhibition in wells with/without clavulanic acid; results inform antimicrobial resistance profiles for clinicians; aids in selection of appropriate antibiotic therapy. ## Clinical Evidence Bench testing only. Study evaluated 95 molecularly characterized isolates (42 ESBL positive) of E. coli, K. oxytoca, K. pneumoniae, and P. mirabilis. Compared turbidity and Prompt® inoculation methods across manual, autoSCAN-4, and WalkAway reading systems. Turbidity method showed 93% sensitivity and 100% specificity. Prompt® method showed 95% sensitivity and 96-98% specificity. Reproducibility demonstrated across 3 sites. ## Technological Characteristics Dried microdilution panels containing Mueller Hinton Broth and nutrients; growth-based detection; non-CO2 incubation; manual or automated (autoSCAN-4, WalkAway) reading; turbidity or Prompt® inoculation methods; compliant with CLSI M7 (M100-S16) standards. ## Regulatory Identification An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases. ## Predicate Devices - MicroScan® Dried ESBL plus ESBL Confirmation Panel ([K020037](/device/K020037.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K061687 B. Purpose for Submission: Confirmatory testing for extended spectrum Beta- lactamase (ESBL) in Escherichia coli, Klebsiella oxytoca, K. pneumonia, and Proteus mirabilis. C. Measurand: ESBL confirmation with: Ceftazidime (1, 8 µg/mL), Ceftazidime/clavulanic acid (0.25/4, 2/4 µg/mL), and Cefotaxime 2, 16 µg/mL), Cefotaxime/clavulanic acid (0.5/4, 4/4 µg/mL) D. Type of Test: Qualitative growth based detection E. Applicant: Dade Behring Dade MicroScan Inc. F. Proprietary and Established Names: MicroScan® Dried Gram-Negative MIC/Combo Panels G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: Class II 3. Product code: JWY - Manual Antimicrobial Susceptibility Test Systems LRG-Instrument for Auto Reader & Interpretation of Overnight Antimicrobial Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial {1} 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): ESBL confirmation with Ceftazidime (1, 8 µg/mL), Ceftazidime/clavulanic acid (0.25/4, 2/4 µg/mL), and Cefotaxime 2, 16 µg/mL), Cefotaxime/clavulanic acid (0.5/4, 4/4 µg/mL) for use with MicroScan® Dried Gram Negative MIC Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan® panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram negative bacilli. 2. Indication(s) for use: The MicroScan® Dried Panels containing ceftazidime/clavulanic acid and cefotaxime/clavulanic acid can be used to confirm the presence of ESBLs production in Escherichia coli, Klebsiella oxytoca, Klebsiella pneumonia, and Proteus mirabilis. 3. Special conditions for use statement(s): The Prompt® method of inoculation is an alternate method of inoculation preparation that is supported in the methodology along with the turbidity method. The stationary and log inoculum methods should not be used with this antibiotic. 4. Special instrument requirements: Readings may be performed on the autoSCAN®-4 and WalkAway® Systems. I. Device Description: This submission is for the AST Panel only. The ID System was not reviewed. The MicroScan® Dried Gram-Negative MIC/Combo Panel contains microdilutions of each antimicrobial agent in various concentrations with Mueller Hinton Broth and various nutrients which are dehydrated and dried in panels. Each panel contains two control wells: a no-growth control well (contains water only/no nutrients or broth), and a growth control well (contains test medium without antibiotic). The panel is rehydrated and inoculated at the same time with 0.1 ml of suspension prepared by the turbidity method (inoculum prepared in water, then 0.1 ml transferred to 25 ml of inoculum water containing pluronic-D/F-a wetting solution) for a final inoculum of 3-7 X 10⁵. The Prompt® method of inoculation is also recommended as an alternate means of preparing the inoculum. The panels are incubated at 35°C in a non-CO₂ incubator for 16-20 hours and read by visual observation of growth. Panels may be {2} read manually, with the autoSCAN®-4 or WalkAway® Systems. # J. Substantial Equivalence Information: 1. Predicate device name(s): MicroScan Dried Gram-Negative MIC/Combo Panels 2. Predicate 510(k) number(s): K020037 ESBL confirmation 1. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Intended Use | MicroScan® Dried Gram-Negative MIC panels for confirmation of ESBL | Same | | Inoculum preparation | Inoculum prepared from isolated colonies using either the Turbidity method or Prompt® system | Same | | Technology | Growth based after 16 hours incubation | Same | | Results | Confirmed ESBL producers report as resistant for all penicillins, cephalosporins and aztreonam | Same | | Differences | | | | Item | Device | Predicate | | Test organism | Escherichia coli, Klebsiella pneumonia, K. oxytoca, and Proteus mirabilis | Escherichia coli, Klebsiella pneumonia, and K. oxytoca | | Antibiotic | Cefotaxime (2, 16 μg/mL)Cefotaxime.clavulanic acid (0.5/4, 4/4 μg/mL)Ceftazidime (1,8 μg/mL)Ceftazidime/clavulanic acid (0.25/4, 2/4 μg/mL) | Cefotaxime and Ceftazidime (0.5-128 μg/mL), Ceftazidime/clavulanic acid and Cefotaxime/clavulanic acid (0.12/4-32/4 μg/mL) | # K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA"; CLSI M7 (M100-S16) "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; {3} Approved Standard". L. Test Principle: After incubation in a non-CO₂ incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organisms are read by determining the lowest antimicrobial concentration showing inhibition of growth. The panels can be read manually and with the autoSCAN®-4 by observing growth or no growth or with the use of the WalkAway® instrument, which uses an optics system with growth algorithms to directly measure organism growth. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility was demonstrated using 12 isolates of *P. mirabilis* E. coli and *Klebsiella spp.* tested at 3 sites on 3 separate days in triplicate. The study included the testing of both the turbidity inoculum method and Prompt® method of inoculation with readings performed manually, with the autoSCAN®-4 and WalkAway® Systems. All methods provided acceptable reproducibility. b. Linearity/assay reportable range: Not Applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Quality Control with *E. coli* ATCC 25922 and *K. pneumoniae* ATCC 700603 were tested with the expected result on most days using the Prompt® and the turbidity method of inoculation with readings performed manually, with the autoSCAN®-4 and WalkAway® Systems. The Prompt® failed Quality control on slightly more occasions than the turbidity method of inoculation but still provided acceptable results overall. The method of reading made no difference in the results. Inoculum density control: A turbidity meter was used for the turbidity inoculation method with daily checks. The Prompt® method of inoculation had colony counts performed periodically throughout the study to determine the average inoculum density since there is no visual check of the inoculum using this device. The average of the Quality Control recommended isolates were acceptable except an occasional colony count outside the recommended range for the CLSI reference method. 4 {4} d. Detection limit: Not Applicable e. Analytical specificity: Not Applicable f. Assay cut-off: Not Applicable # 2. Comparison studies: a. Method comparison with predicate device: A total of 95 isolates of $P$ mirabilis, $E$ coli, and $K$ oxytoca and $K$ pneumonia that were previously molecular characterized were tested at one site. Forty two of these were ESBL positive. These 95 were tested with both the Prompt® and the turbidity methods of inoculation. Data was analyzed using the streamlined dilutions of Ceftazidime (1, 8 μg/mL), Ceftazidime/clavulanic acid (0.25/4, 2/4 μg/mL), and Cefotaxime 2, 16 μg/mL), Cefotaxime/clavulanic acid (0.5/4, 4/4 μg/mL) and compared to the expected molecular result. Results were exactly the same no matter which read method was used with the turbidity method of inoculation (see chart below for % agreement) The Prompt® method of inoculation had more variability with both one additional false positive with the manual read method and 2 false positives with the instrument read results. The following charts demonstrate the performance as compared to molecular characterization using the turbidity and the Prompt® methods of inoculation with results read manually and with the AutoSCAN®-4 and WalkAway® Systems. Turbidity Method of Inoculation | Organism | Read Method | | | | | | | --- | --- | --- | --- | --- | --- | --- | | | MANUAL | | WALKAWAY | | autoSCAN-4 | | | | ESBL + | ESBL - | ESBL + | ESBL - | ESBL + | ESBL - | | E. coli | 11/13* | 13/13 | 11/13 | 13/13 | 11/13 | 13/13 | | K. spp. | 16/16 | 18/18 | 16/16 | 18/18 | 16/16 | 18/18 | | P. mirabilis | 12/13* | 22/22 | 12/13 | 22/22 | 12/13 | 22/22 | | TOTAL | 39/42 | 53/53 | 39/42 | 53/53 | 39/42 | 53/53 | | % agreement with expected (95% CI) | 93% (80.5-98.5) | 100% (93.3 - 100) | 93% (80.5-98.5) | 100% (93.3 - 100) | 93% (80.5-98.5) | 100% (93.3 - 100) | {5} Prompt® Method of Inoculation | Organism | Read Method | | | | | | | --- | --- | --- | --- | --- | --- | --- | | | MANUAL | | WALKAWAY | | autoSCAN-4 | | | | ESBL + | ESBL - | ESBL + | ESBL - | ESBL + | ESBL - | | E. coli | 12/13* | 12/13 | 12/13 | 11/13 | 12/13 | 11/13 | | K. spp. | 16/16 | 18/18 | 16/16 | 18/18 | 16/16 | 18/18 | | P. mirabilis | 12/13* | 22/22 | 12/13 | 22/22 | 12/13 | 22/22 | | TOTAL | 40/42 | 52/53 | 40/42 | 51/53 | 40/42 | 51/53 | | % Agreement with expected (95% CI) | 95% (83.8-99.4) | 98% (89.9-100) | 95% (83.8-99.4) | 96% (87.0-99.6) | 95% (83.8-99.4) | 96% (87.0-99.6) | *One E. coli and one P. mirabilis were false negative when compared to the molecular characterized expected result. These were also falsely negative when testing was performed as recommended by the CLSI reference method. b. Matrix comparison: Not Applicable 3. Clinical studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable 4. Clinical cut-off: Not Applicable 5. Expected values/Reference range: Quality Control values and recommendations are included in the package insert. # N. Proposed Labeling: Quality Control testing is the same as recommended in the reference method {6} described by CLSI and is included in the package insert. The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. **O. Conclusion:** The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 7 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY/K061687](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY/K061687) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com