← Product Code [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) · K063366

# MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE (K063366)

_Dade Behring, Inc. · LON · Dec 8, 2006 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K063366

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON.md)
- **Decision Date:** Dec 8, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1645
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Intended Use

The MicroScan® Synergies plus™ Gram-Positive 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-positive enterococci and staphylococci. After inoculation, panels are incubated for 4.5 -- 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

## Device Story

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels utilize growth-based detection to determine antimicrobial susceptibility. Input: isolated colonies from solid media cultures, prepared via turbidity method in saline/Pluronic® broth. Panels contain dehydrated antibiotic (Synercid) and control wells. Operation: panels incubated in WalkAway®-SI system; colorimetric optics system (lamp/photosensor) monitors growth periodically from 4.5 to 16 hours (rapid) or 16-24 hours (overnight). Output: MIC values and qualitative susceptibility interpretations. Used in clinical microbiology laboratories by technicians. Results assist clinicians in selecting appropriate antibiotic therapy for Gram-positive infections.

## Clinical Evidence

Clinical study evaluated 350 Gram-positive isolates (308 fresh, 42 stock) across 3 sites. Performance compared rapid read (<16h) and overnight methods against CLSI reference broth dilution. Rapid read method achieved 97.1% Essential Agreement (EA) and 97.7% Category Agreement (CA) for Long Dilution, and 98.0% CA for 5-Dilution Breakpoint. Reproducibility >95%. No very major errors in challenge set. Bench testing confirmed growth rates >95%.

## Technological Characteristics

Miniaturized broth dilution susceptibility test; dehydrated antimicrobial agents in panel wells. Rehydration with Synergies plus™ Pos Broth. Incubation 4.5–18 hours at 35°C. Automated reading via MicroScan® instrumentation (WalkAway® SI) or visual reading. Connectivity: WalkAway® SI system integration.

## 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 Panels

## 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/).

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
K063366

B. Purpose for Submission:
To add Synercid (Quinupristin/Dalfopristin) at concentrations of 0.12 to 8 µg/mL Long Dilution Sequence and 0.12 to 2 µg/mL 5-Dilution Breakpoint Sequence, for enterococci and staphylococci, to the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels

C. Measurand:
Synercid at 0.12 — 8 µg/mL Long Dilution
Synercid at 0.12 — 2 µg/mL 5-Dilution Breakpoint

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

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3. Product code:
LON – Automated AST system short incubation
LRG – Instrument for Auto Reader &amp; Interpretation of Overnight Antimicrobial Susceptibility Systems
JWY – Manual Antimicrobial Susceptibility Test Systems
LTT – Panels, Test, Susceptibility, Antimicrobial

4. Panel:
83 Microbiology

H. Intended Use:

1. Intended use(s):
MicroScan® Synergies plus™ Gram-Positive Panels, with Synercid, are intended for determination of susceptibility of Gram-positive enterococci and staphylococci to the antimicrobial agent Synercid. 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).

2. Indication(s) for use:
The MicroScan® Synergies plus™ Gram-Positive 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-positive enterococci and staphylococci.

The testing of Synercid (Quinupristin/Dalfopristin) at concentrations of 0.12 – 8 µg/mL Long Dilution Sequence and 0.12 – 2 µg/mL 5-Dilution Breakpoint Sequence, on the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is indicated for testing enterococci and staphylococci at 4.5-16 hours or 16-20 hours for an overnight reading. The Gram-positive organisms which may be tested on this panel are Enterococcus faecium (vancomycin-resistant and multi-drug resistant strains only) and Staphylococcus aureus (methicillin-susceptible strains only).

3. Special conditions for use statement(s):
Turbidity method of inoculum preparation only.
For prescription use only.

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 a very small amount (0.1%)

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of Pluronic®--a wetting agent, then 0.1 ml is 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 (Minimum Inhibitory Concentration).

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 MIC/Combo Panels and
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels

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 synercid in water | Dried clindamycin or gentamicin in broth  |
|  Reading |   | Uses both an early read and | Overnight system uses only  |

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|   | overnight read methods in the same system | the overnight reading method 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 | Synercid (0.12 – 8 μg/mL Long Dilution Sequence and 0.12 – 2 μg/mL 5-Dilution Breakpoint Sequence) | Different concentrations depending on the antibiotic  |

## 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-S16) “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 user customization, 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):

Data on the gram-positive panel for Synercid at 0.12 — 8 μg/mL (Long Dilution Sequence) and Synercid at 0.12 — 2 μg/mL (5-Dilution Breakpoint Sequence) were evaluated. The Synergies plus™ readings were obtained at times between 4.5 and 16 hours of incubation (Rapid read method). An additional comparison was done with readings on the instrument after 16 – 18 hours incubation for the Overnight Instrument read method, and also for the Overnight Manual read method, when incubated 16- 18 hours and read visually.

This submission is for the AST Panel only. The ID System was not reviewed.

1. Analytical performance:

a. Precision/Reproducibility:

Reproducibility was demonstrated using 10 isolates tested at 3 sites on 3 separate

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days in triplicate. The study included the testing on the WalkAway® SI read at &lt;16 hours, WalkAway® 16-18 hour readings and manual readings at 16-20 hours incubation. The overall reproducibility results were &gt;95% reproducible for the Long Dilution Sequence and the 5-Dilution Breakpoint Sequence.

There was a slight trend for the &lt;16 hour reading method to produce more susceptible results.

b. Linearity/assay reportable range:

Not Applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The recommended QC isolates were tested a sufficient number of times with acceptable results on most testing days with the reference method.

The percent that did not grow in the 4.5-16 hour window for the E. faecalis QC organism was 0%; the percent that did not grow in the 4.5-16 hour window for the S. aureus QC organism was 2%. Quality control results demonstrated the ability of the different reading parameters (manual and instrument) to produce acceptable results &gt;95% of the time.

The following table provides the frequency of the results in each concentration with the expected range stated.

Quality Control - Synercid

|  Results  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Organism | Conc in μg/mL | # reference | MicroScan®  |   |   |   |
|  Synercid Long Dilution |  |  | Manual overnight | Instrument overnight | <16 hrs instrument  |   |
|  E. faecalis ATCC 29212 Range 2 – 8 μg/mL | 1 |  |  |  |   |   |
|   |  2 | 76 |  |  | 47  |   |
|   |  4 | 13 | 95 | 102 | 62  |   |
|   |  8 |  | 17 | 9 | 2  |   |
|   |  >8 |  |  |  |   |   |
|  Results  |   |   |   |   |   |   |
|  Organism | Conc in μg/mL | # reference | MicroScan®  |   |   |   |
|  Synercid Long Dilution |  |  | Manual overnight | Instrument overnight | <16 hrs instrument  |   |
|  S. aureus ATCC 29213 | <=0.12 | 1 |  |  |   |   |
|   |  0.25 | 91 | 39 | 45 | 19  |   |

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|  Range
0.25 – 1
μg/mL | 0.5 | 1 | 55 | 48 | 74  |
| --- | --- | --- | --- | --- | --- |
|   |  1 | 2 | 2 | 1 | 2  |
|   |  2 |  | 3 | 3 | 2  |
|   |  4 |  | 1 | 2 | 2  |
|   |  >=8 |  |  | 1 | 1  |
|  Results  |   |   |   |   |   |
|  Organism | Conc. in
μg/mL | # reference | MicroScan®  |   |   |
|  Synercid
5 - BP
Dilutions |  |  | Manual overnight | Instrument overnight | <16 hrs instrument  |
|  E. faecalis
ATCC 29212
Range
2 – >2 μg/mL | <=0.12 |  |  |  |   |
|   |  0.25 |  |  |  |   |
|   |  0.5 |  |  |  |   |
|   |  1 |  |  |  |   |
|   |  2 | 76 |  |  | 47  |
|   |  >2 | 13 | 112 | 111 | 64  |
|  |   |   |   |   |   |
|  Results  |   |   |   |   |   |
|  Organism | Conc. in
μg/mL | # reference | MicroScan®  |   |   |
|  Synercid
5 - BP
Dilutions |  |  | Manual overnight | Instrument overnight | <16 hrs instrument  |
|  S. aureus
ATCC 29213
Range
0.25 – 1
μg/mL | <=0.12 | 1 |  |  | 2  |
|   |  0.25 | 91 | 39 | 45 | 62  |
|   |  0.5 | 1 | 55 | 48 | 30  |
|   |  1 | 2 | 2 | 1 | 1  |
|   |  2 |  | 3 | 4 | 3  |
|   | >2 |  | 1 | 2 | 2  |
|  |   |   |   |   |   |

**Long Dilution:** The mode for the reference method is more susceptible than the mode produced by each reading method on the instrument, if only by one dilution, for both the *E. faecalis* and the *S. aureus* QC strains.

**5 – Dilution E. faecalis:** The mode for the reference method is more susceptible than the mode produced by each reading method on the instrument, if only by one dilution.

**5 – Dilution S. aureus:** The mode for the reference method is the same as the mode produced by the &lt;16 hours rapid reading method.

No QC trending was observed.

Inoculum density control: A turbidity meter was used for the turbidity inoculation method. Turbidity inoculum verification provided.

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d. Detection limit:

Not Applicable

e. Analytical specificity:

Not Applicable

f. Assay cut-off:

Not Applicable

2. Comparison studies:

The gram-positive Efficacy Study data were analyzed for both the seven (7) well Long Dilution Sequence (0.12 – 8 µg/mL) and the five (5) well 5-Dilution Breakpoint Sequence (0.12 – 2 µg/mL) for enterococci and staphylococci, for which clearance is requested. The dilutions provide on-scale results for at least 1 of the CLSI gram-positive Quality Control strains. Performance claims are based on Rapid read method (&lt;16 hours) results compared to the reference method overnight results.

a. Method comparison with predicate device:

Clinical testing was conducted at 3 sites. A total of 350 Clinical gram-positive isolates were tested of which 308 were fresh isolates and 42 were stock isolates. Seven (7) isolates for the Long Dilution Sequence and the Breakpoint Dilution Sequence were reported at &gt;= 16 hours and were not included as Rapid read results. Therefore, of the 350 isolates tested, 343 Rapid read Long Dilution isolates were analyzed. There were 75 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. Two (2) isolates for the Long Dilution Sequence and one (1) Challenge isolate for the 5-Breakpoint Dilution Sequence were reported at ≥ 16 hour and were not included in the Rapid Read Method results.

The Synergies plus™ readings were obtained at times between 4.5 and 16 hours of incubation for &gt;95% of the results. An additional comparison was done with readings on the instrument after overnight incubation and also read manually when incubated 16-18 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%) of Pluronic® (a wetting agent) 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.

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QC was also performed with no difference apparent in the results. The chart below demonstrates the performance of all three reading methods (Synergies plus™ readings at &lt;16 hours, overnight on the WalkAway® and manually read at 18 hours using the touchScan®-SR) when compared to the reference method for both dilution sequences.

Clinical and Challenge Data - Read Method comparisons for Synercid

|   | Total | EA | %EA | Total evaluable | EA of evaluable | %EA | CA | %CA | #R | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  <16 h
• Long
• 5-Dil BP | 416 | 405 | 97.4 | 293 | 286 | 97.6 | 407 | 97.8 | 4 | 4 | 2 | 3  |
|   |  417 | NA | NA | NA | NA | NA | 409 | 98.1 | 4 | 5 | 0 | 3  |
|  Overnight Instrument
• Long
• 5-Dil BP | 425 | 406 | 95.5 | 318 | 309 | 97.2 | 416 | 97.9 | 4 | 7 | 1 | 1  |
|   |  425 | NA | NA | NA | NA | NA | 416 | 97.9 | 4 | 7 | 1 | 1  |
|  Overnight Manual
• Long
• 5-Dil BP | 425 | 406 | 95.5 | 317 | 307 | 96.8 | 414 | 97.4 | 4 | 10 | 1 | 0  |
|   |  425 | NA | NA | NA | NA | NA | 414 | 97.4 | 4 | 10 | 1 | 0  |

EA-Essential Agreement<br/>maj-major discrepancies<br/>CA-Category Agreement<br/>vmj-very major discrepancies<br/>R-resistant isolates<br/>min- minor discrepancies<br/>NA – Essential Agreement results are not applicable for Breakpoint format

Essential agreement (EA) is when the MicroScan® Synergies plus panel agrees with the reference test panel results exactly or within one doubling dilution of the reference method. Category agreement (CA) is when the MicroScan® Synergies plus panel interpretation agrees exactly with the reference panel interpretation. Evaluable (Eval) are results that are within the test range and on scale.

Of the 75 Challenge isolates tested, the expected results for 74 strains were Susceptible and 1 strain was Intermediate. Two (2) isolates for the Long Dilution Sequence and one (1) Challenge isolate for the 5-Breakpoint Dilution Sequence were reported at ≥ 16 hour and were not included in the Rapid Read Method results.

There were no very major or maj errors in the Challenge Set data. One min error was generated by one Enterococcus faecium (vancomycin susceptible) for the &lt;16 hour Rapid read method. One E. faecium (vancomycin resistant) and one S. aureus (methicillin-resistant) isolate generated two minor errors in the Overnight Instrument and Overnight Manual reading methods, for the Long Dilution and the 5-Dilution Breakpoint Sequence data, respectively. The overall combined EA and the CA for the Challenge Set Data was &gt;90% for all read methods and dilution combinations. Therefore, the Challenge Set performance data are acceptable.

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Performance claims (in **bold**) that will appear in the labeling and the procedural manual are based on the Clinical data Rapid read (&lt;16 hour) method results only. The table below displays the Clinical data results compared by reading method.

## Clinical Data Read Method Comparison - Synercid

|   | Total | EA | %EA | Total evaluable | EA of evaluable | %EA | CA | % CA | #R | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  <16 h
• Long
• 5-Dil BP | 343 | 333 | 97.1 | 236 | 230 | 97.5 | 335 | 97.7 | 4 | 3 | 2 | 3  |
|   |  343 | NA | NA | NA | NA | NA | 336 | 98.0 | 4 | 4 | 0 | 3  |
|  Overnight Instrument
• Long
• 5-Dil BP | 350 | 335 | 95.7 | 256 | 251 | 98.0 | 343 | 98.0 | 4 | 5 | 1 | 1  |
|   |  350 | NA | NA | NA | NA | NA | 343 | 98.0 | 4 | 5 | 1 | 1  |
|  Overnight Manual
• Long
• 5-Dil BP | 350 | 336 | 96.0 | 255 | 250 | 98.0 | 342 | 97.7 | 4 | 7 | 1 | 0  |
|   |  350 | NA | NA | NA | NA | NA | 342 | 97.7 | 4 | 7 | 1 | 0  |

The Clinical data Rapid read method EA of 97.1% and the CA of 97.7% are both very good. Overnight Instrument and Manual read methods EA and CA are both very similar to the Rapid read method results for the Long Dilution and the 5-Dilution Breakpoint Sequence data results.

There were 3 vmj errors (3/4, 75%) produced by 3 different *Staphylococcus* species at two different sites, generated only by the Rapid read method. Because of the low number of resistant isolates, the overall vmj error rates appear to be elevated. Further analysis of these 3 isolates demonstrated that there appeared to be a problem with the entire antibiogram.

The 1 vmj (1/4, 25%) generated in the Overnight Instrument read method results was produced by 1 *Staphylococcus epidermidis* (methicillin-resistant) isolate. Because this organism group will not be reported for this antibiotic/organism combination, this result may be considered to have minimal impact on the overall performance, since the EA and CA are very good.

There appears to be a trend for the device to produce a slightly more resistant result as compared to the reference method, if only by one dilution, but still remaining within EA. This trend was not observed in the reproducibility study, but was demonstrated in the QC performance data for both organism strains.

The EA and the CA are within acceptable limits for all reading methods, and the CA for

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the 5-Dilution Breakpoint Sequence data are all very good. The performance data are acceptable for both the Long Dilution Sequence and for the 5-Dilution Breakpoint Sequence results using the Rapid read (&lt;16 hour) method.

The device had a growth rate of &gt;95%.

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 aureus (methicillin-susceptible only):

&lt;=1 (S), 2 (I), &gt;=4 (R)

Enterococcus faecium (vancomycin-resistant and multi-drug resistant):

&lt;=1 (S), 2 (I), &gt;=4 (R)

The interpretative criteria and Quality Control Ranges 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.

Performance characteristic claims that will be added to the Procedural Manual and to the labeling were based on the Clinical data Rapid read (&lt;16 hour) method results only.

O. Conclusion:

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The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K063366](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K063366)

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