← Product Code [LON](/productcode/LON) · K052346 # SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS (K052346) _Dade Behring, Inc. · LON · Oct 26, 2005 · Microbiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K052346 ## Device Facts - **Applicant:** Dade Behring, Inc. - **Product Code:** [LON](/productcode/LON.md) - **Decision Date:** Oct 26, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.1645 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for Use Penicillin at concentrations of 0.03 to 4 µg/mL for Staphylococci and 0.5 to 64 µg/mL for Enterococci on the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is intended for use with MicroScan® Synergies plus™ Panels read on the WalkAway® -SI System (including upgraded WalkAway® -40 or WalkAway® -96 to meet WalkAway® SI equivalence). MicroScan® panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive cocci and Listeria. ## Device Story MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels determine antimicrobial susceptibility of gram-positive cocci. Panels contain dehydrated antibiotics and control wells; rehydrated with 0.1 mL of turbidity-prepared inoculum (3-7 x 10⁵ CFU/mL). Panels incubated in WalkAway®-SI system; optical system uses colorimetric light detection to monitor growth. System performs periodic reads starting at 4.5 hours until MIC determination; supports overnight incubation (16-24 hours) with manual or instrument reading. Healthcare providers use MIC results to guide antibiotic therapy for bacterial infections. Benefits include rapid susceptibility testing, reducing time to appropriate clinical decision-making. ## Clinical Evidence Bench testing only. Study compared MicroScan® Synergies plus™ (rapid read) and overnight methods (instrument/manual) against CLSI reference broth dilution. Total 672 isolates (534 clinical, 138 challenge). Rapid read: 92.8% EA, 99.0% CA. Overnight instrument: 97.5% EA, 99.6% CA. Overnight manual: 97.6% EA, 99.7% CA. QC isolates (E. faecalis ATCC 29212, S. aureus ATCC 29213) showed acceptable performance across all methods. ## Technological Characteristics Growth-based antimicrobial susceptibility test. Materials: dehydrated antibiotics in panel wells. Sensing: Colorimetric optics (color wheel/lamp assembly, photosensor). Energy: Electrical (WalkAway®-SI instrument). Dimensions: Multi-well panel format. Connectivity: WalkAway®-SI system. Sterilization: Not specified. Software: Automated growth detection algorithm. ## Regulatory Identification A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases. ## Special Controls *Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.” ## Predicate Devices - MicroScan® Dried Gram-Positive and Gram-Negative MIC/Combo Panels (k862140, k020185) ## 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: K052346 B. Purpose for Submission: For addition of Penicillin G on the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels for testing appropriate Staphylococcus spp and Enterococcus spp C. Measurand: Penicillin (0.03 – 4 µg/mL for Staphylococci and 0.5 – 64 µg/mL for Enterococci) D. Type of Test: Quantitative and Qualitative growth based detection algorithm using optics light detection E. Applicant: Dade Behring Inc, MicroScan® F. Proprietary and Established Names: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels G. Regulatory Information: 1. Regulation section: 866.1645 - Fully automated short-term incubation cycle antimicrobial susceptibility system 866.1640 - Antimicrobial Susceptibility Test Powder 2. Classification: Class II 3. Product code: LON – Automated AST system short incubation LRG-Instrument for Auto Reader & Interpretation of Overnight Antimicrobial Susceptibility Systems JWY - Manual Antimicrobial Susceptibility Test Systems LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: 83 Microbiology {1} H. Intended Use: 1. Intended use(s): Penicillin at concentrations of 0.03 to 4 µg/mL for Staphylococci and 0.5 to 64 µg/mL for Enterococci on the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is intended for use with MicroScan® Synergies plus™ Panels read on the WalkAway® -SI System (including upgraded WalkAway® -40 or WalkAway® -96 to meet WalkAway® SI equivalence). MicroScan® panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive cocci and Listeria. 2. Indication(s) for use: The addition of penicillin at concentrations of 0.03 to 4 µg/mL for testing Staphylococci and 0.5 to 64 µg/mL for testing Enterococci to the gram-positive test panel at 4.5-16 hours or 16-20 hours for an overnight reading. 3. Special conditions for use statement(s): - Turbidity method of inoculum preparation only. - For prescription use only. - S. saprophyticus will not be reported 4. Special instrument requirements: Not Applicable I. Device Description: Each panel contains two control wells: a negative control well, and a growth control well (contains test medium without antibiotic). Antibiotics are diluted in water, buffer, or minute concentrations of broth to selected concentrations prior to dehydration of the panels. The panel is rehydrated and inoculated at the same time with 0.1 ml of suspension prepared by the turbidity method (inoculum prepared in 0.4% saline with PLURONIC®, then 0.1ml transferred to 25ml of inoculum Synergies plus Pos Broth with PLURONIC®) for a final inoculum concentration of 3-7 X 10⁵ CFU/ml. Panels are incubated in a Walk-Away® System and read periodically starting at 4.5 hours until sufficient growth to determine the MIC. Alternately the panels may be incubated at 35°C in a non-CO₂ for 16-24 hours and read by visual observation of growth. J. Substantial Equivalence Information: 1. Predicate device name(s): MicroScan® Dried Gram-Positive and Gram-Negative MIC/Combo Panels {2} 2. Predicate 510(k) number(s): k862140 k020185 3. Comparison with predicate: | Similarities | | | | | --- | --- | --- | --- | | Item | | Device | Predicate | | Intended use | | MicroScan® panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic organisms | Same | | Specimen | | Isolated colonies from culture used | Same | | Inoculum | | Inoculum density to 0.5 McFarland standard | Same | | Incubation | | <16 hours 16 – 24 hours | Same | | Results | | Quantitative with qualitative interpretations | Same | | Technology | | Growth based | Same | | Differences | | | | | Item | | Device | Predicate | | Panels | | Dried penicillin in water | Dried clindamycin or gentamicin in broth | | Reading | | Uses both an early read and overnight methods in the same system | Overnight system uses only the overnight reading methods and <16 hour instruments use only the <16 hour read methods. | | Inoculum preparation | | Turbidity method of inoculation only. | Inoculum prepared from isolated colonies using either the Turbidity method or Prompt® system | | Instrument | | WalkAway® -SI System or equivalent | autoScan® -4 or WalkAway® | | Antibiotic | | Penicillin 0.03 – 4 μg/mL for Staphylococci 0.5 – 64 μg/mL for Enterococci | Different concentrations depending on the antibiotic | {3} K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA”; Clinical and Laboratory Standards Institute (CLSI) M7 (M100-S15) “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard”. L. Test Principle: The WalkAway® SI uses a Colorimetric Optics System consisting of a color wheel/lamp assembly and a Photosensor. There is an initial read at 2.5 hours with a possible final read at 4.5, 5.5, 6.5, 8, 12, 16, or 18 hours (overnight instrument readings, manual readings) depending on the growth rate of the organism being tested. The time of final read is dependent on the growth rate of the organism and the sensitivity of the automatic reader since cell densities below $2 \times 10^{7}$ cells/ml are not detected. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility was demonstrated using 20 isolates tested at 3 sites on 3 separate days in triplicate. The study included the testing on the WalkAway® SI read at <16 hours, WalkAway® 16-18 hour readings and manual readings at 16-20 hours incubation. The WalkAway® SI had 3 results that were not readable at ≥16 hours. All results were >95% reproducible. b. Linearity/assay reportable range: Not Applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): The recommended QC isolates, E. faecalis ATCC 29212 and S. aureus ATCC 29213 were tested a sufficient number of times with acceptable results on all testing days with the reference method. The reference and the three different read methods had the same mode with E. faecalis ATCC 29212. However, the mode of the reference method was different from the 3 different read methods with the S. aureus ATCC 29213 but still within essential agreement therefore this QC is acceptable. The main purpose of the S. aureus ATCC 29213 QC organism is to demonstrate that it is a penicillinase producer with an expected range of ≥0.25. E. faecalis 29212 appears to be a better indicator of the activity of penicillin. 4 {4} Quality control results demonstrated the ability of the different reading parameters (manual and instrument) to produce acceptable results. The following table provides the frequency of the results in each concentration with the expected range stated. | Results | | | | | | | --- | --- | --- | --- | --- | --- | | Organism | Conc in μg/mL | # reference | MicroScan® | | | | | | | Manual overnight | Instrument overnight | Synergies Plus | | E .faecalis ATCC 29212 Expected Range: 1 – 4 μg/mL | 1 | 83 | 83 | 84 | 81 | | | 2 | 3 | 3 | 2 | 5 | | | | | | | | | | | | | | | | | | | | | | | S. aureus ATCC 29213 Expected Range: 0.25 – 2 μg/mL | 0.25 | 2 | | | | | | 0.5 | 39 | 1 | | | | | 1 | 28 | 27 | 27 | 51 | | | 2 | 12 | 26 | 25 | 18 | | | 4 | 4 | 22 | 24 | 14 | | | >4 | | 9 | 9 | 2 | Inoculum density control: A turbidity meter was used for the turbidity inoculation method. 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: Clinical testing was conducted at 3 sites using fresh isolates supplemented with stock isolates. A total of 534 gram-positive isolates were tested of which 469 were fresh isolates and 65 were stock isolates. There were 138 challenge isolates tested at one site and compared to the reference broth dilution result mode that was determined by previous testing of each isolate multiple times in the recommended reference panel. The Synergies plus™ readings were obtained at times between 4.5 and 16 hours of incubation for >99% of the results. An additional comparison was done with readings on the instrument after overnight incubation and also read manually when incubated 16-18 5 {5} hours. Performance by these alternate reading methods was also acceptable with no apparent differences or trends. The recommended CLSI reference method was followed with the exception of the use of a small amount (0.1%) PLURONIC® in the final inoculum. A validation of the use of PLURONIC® in the frozen reference panels was conducted. Similar calculations for the different reading methods were performed with very little difference. The test device had a no growth rate of <10%. The charts below demonstrated the performance of all three reading methods (Synergies plus™ readings at <16 hours, overnight on the WalkAway® and manually read at 18 hours using the touchScan®-SR) when compared to the reference method. Summary Table for the Rapid Instrument Read | | Total | EA | %EA | Total evaluable | EA of evaluable | %EA | CA | %CA | #R | min | maj | vmj | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Efficacy | 530 | 487 | 91.9 | 254 | 238 | 93.7 | 525 | 99.1 | 325 | N/A | 3 | 2 | | Challenge | 138 | 133 | 96.4 | 62 | 58 | 93.5 | 136 | 98.6 | 90 | N/A | 1 | 1 | | Combined | 668 | 620 | 92.8 | 316 | 296 | 93.7 | 661 | 99.0 | 415 | N/A | 4 | 3 | Summary Table for the Overnight Instrument Read | | Total | EA | %EA | Total evaluable | EA of evaluable | %EA | CA | %CA | #R | min | maj | vmj | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Efficacy | 534 | 518 | 97.0 | 251 | 236 | 94.0 | 531 | 99.4 | 325 | N/A | 3 | 0 | | Challenge | 138 | 137 | 99.3 | 64 | 63 | 98.4 | 138 | 100 | 90 | N/A | 0 | 0 | | Combined | 672 | 655 | 97.5 | 315 | 299 | 94.9 | 669 | 99.6 | 415 | N/A | 3 | 0 | Summary Table for the Overnight Manual Read | | Total | EA | %EA | Total evaluable | EA of evaluable | %EA | CA | %CA | #R | min | maj | vmj | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Efficacy | 534 | 519 | 97.2 | 249 | 235 | 94.4 | 532 | 99.6 | 325 | N/A | 2 | 0 | | Challenge | 138 | 137 | 99.3 | 64 | 63 | 98.4 | 138 | 100 | 90 | N/A | 0 | 0 | | Combined | 672 | 656 | 97.6 | 313 | 298 | 95.2 | 670 | 99.7 | 415 | N/A | 02 | 0 | EA-Essential Agreement CA-Category Agreement R-resistant isolates maj-major discrepancies vmj-very major discrepancies min- minor discrepancies NA - No intermediate range therefore no minor errors possible Evaluable results are those that fall within the test range of the reference method and could also be on-scale with the new device if within the plus/minus one dilution variability. EA is when there is agreement between the reference method and the MicroScan® within plus or minus one serial two-fold dilution of antibiotic. CA is when the interpretation of the reference method agrees exactly with the interpretation of the MicroScan® result. {6} A slight trend was observed where the S. aureus in the QC and efficacy studies was more resistant in the test method than the reference method but still in essential agreement. This trending was observed in all three read methods. 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: Staphylococcus spp. ≤0.12 (S), ≥0.25 (R) Enterococcus spp. ≤8 (S), ≥16 (R) The interpretative criteria and Quality Control Ranges are the same as recommended in the CLSI. All values are included in the package insert. N. Proposed Labeling: 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. --- **Source:** [https://fda-staging.innolitics.com/device/K052346](https://fda-staging.innolitics.com/device/K052346) **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. 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