← Product Code [LTT](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT) · K091264

# MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 (K091264)

_Siemens Healthcare Diagnostics · LTT · Jul 22, 2009 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT/K091264

## Device Facts

- **Applicant:** Siemens Healthcare Diagnostics
- **Product Code:** [LTT](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT.md)
- **Decision Date:** Jul 22, 2009
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1640
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent suscept of colonies grown on solid media of rapidly growing arcoire and the stores of the stores of the stores of the stores of the stores of the lock of the lock for t on anous at 3 visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the evaluation of antimicrobi vancomycin on the MicroScan Dried Gram-Positive MIC/Combo Panels utilizing the updated Staphylococcus aureus interpretative criteria (S ≤ 2, I = 4 -8, R ≥ 16). The gram-positive organisms which may be used for vancomycin susceptibility testing in this panel are: Enterococcus spp. (e.g., Enterococcus faecalis) Staphylococcus spp. (including Staphylococcus aureus) Staphylococcus epidermidis (including methicillin-resistant strains) Streptococcus agalactiae Streptococcus bovis

## Device Story

MicroScan® Dried Gram-Positive MIC/Combo Panels contain dehydrated microdilutions of antimicrobial agents in Mueller Hinton Broth. Panels are rehydrated and inoculated with bacterial suspensions (turbidity or Prompt™ method) at 3-7x10^5 CFU/ml. Incubation occurs at 35°C for 16-24 hours. Growth is assessed via visual observation or automated optics systems (autoSCAN® 4 or WalkAway®). The device determines the Minimum Inhibitory Concentration (MIC) and categorical interpretation (SIR) for Vancomycin. Results assist clinicians in identifying antimicrobial susceptibility for gram-positive cocci, including S. aureus. The system provides quantitative/qualitative data to guide antibiotic therapy decisions.

## Clinical Evidence

Bench testing only. Re-evaluation of 51 clinical and 43 challenge S. aureus isolates from original K051202 submission using updated breakpoints. Combined performance across all inoculation/reading methods showed >95% Essential Agreement (EA). Category Agreement (CA) for challenge isolates was >90% when minor discrepancies within EA were excluded. No new clinical studies were conducted.

## Technological Characteristics

Miniaturized broth dilution susceptibility test; dehydrated antimicrobial agents in panel wells. Rehydrated with water. Incubation 16-20 hours at non-CO2 conditions. Compatible with visual or automated MicroScan instrumentation reading. Complies with Class II Special Controls Guidance for AST systems.

## 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 Gram-Positive MIC/Combo Panels – Vancomycin ([K051202](/device/K051202.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}

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K091264

B. Purpose for Submission:
Device Modification – re-evaluation K051202 performance data using the new FDA approved breakpoint interpretive criteria for Vancomycin (S≤2, I= 4 – 8, R≥16) used in conjunction with S.aureus.

C. Measurand:
Vancomycin 0.25 -128 µg/ml

D. Type of Test:
Qualitative and quantitative growth based detection algorithm using optics light detection.

E. Applicant:
Siemens Healthcare Diagnostics

F. Proprietary and Established Names:
MicroScan® Dried Gram-Positive MIC/Combo Panels with Vancomycin (0.25 – 128 µg/ml)

G. Regulatory Information:
1. Regulation section:
21 CFR 866.1640 Antimicrobial Susceptibility Test Powder
2. Classification: II

{1}

3. Product codes:

JWY – Manual Antimicrobial Susceptibility Test Systems

LRG – Instrument for Auto Reader and Interpretation of Overnight Susceptibility Systems.

LTW – Susceptibility Test Cards, Antimicrobial

LTT – Panels, Test, Susceptibility Antimicrobial

4. Panel:

83 Microbiology

H. Intended Use:

1. Intended use(s):

For use with MicroScan® Dried Gram Positive MIC/Combo, Dried Gram Positive Breakpoint Combo and Dried Gram Positive ID Type 2 panels.

MicroScan® Positive panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci and Listeria monocytogenes. Refer to Limitations of Procedures section of the package insert for use with fastidious streptococci.

2. Indication(s) for use:

The MicroScan® Dried 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 cocci. After inoculation, panels are incubated for 16-24 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 evaluation of antimicrobial agent Vancomycin on the MicroScan Dried Gram-Positive MIC/Combo Panels utilizing the updated Staphylococcus aureus interpretative criteria (S≤2, I = 4-8, R≥16).

{2}

The gram positive organisms which may be used for Vancomycin susceptibility testing in this panel are:

- Enterococcus spp. (e.g., Enterococcus faecalis)
- Staphylococcus spp. (including Staphylococcus aureus)
- Staphylococcus epidermidis (including methicillin-resistant strains)
- Streptococcus agalactiae
- Streptococcus bovis

3. Special conditions for use statement(s):

For prescription use only.

The Prompt™ method of inoculation is an alternate method of inoculum 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:

These panels can be read at $\geq 16$ hours of incubation either manually, automatically on the autoSCAN® 4, or with the WalkAway® instrument system. For best detection of VRSA, vancomycin results with staphylococci should be read/interpreted after 18 hours, especially when using the autoSCAN® 4 instrument to read results.

I. Device Description:

The MicroScan® Dried Gram-Positive 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 $0.1\mathrm{ml}$ of suspension prepared by the turbidity method (i.e., inoculum prepared in water, then $0.1\mathrm{ml}$ transferred to $25\mathrm{ml}$ of inoculum water containing Pluronic-D/F – a wetting solution) for a final inoculum concentration of $3 - 7\times 10^{5}\mathrm{CFU / ml}$. The Prompt™ method of inoculation is also recommended as an alternate means of preparing the inoculum. The panels are incubated at $35^{\circ}\mathrm{C}$ in a non-CO2 environment, for 16-24 hours. The panels are then read by visual observation of growth. Panels may also be read automatically with the autoSCAN® or the WalkAway® instruments.

J. Substantial Equivalence Information:

1. Predicate device name(s):

MicroScan® Dried Gram-Positive MIC/Combo Panels – Vancomycin

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2. Predicate K number(s):

K051202

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  1. Product Name | MicroScan® Dried Gram-Positive MIC/Combo Panels – Vancomycin | MicroScan® Dried Gram-Positive MIC/Combo Panels – Vancomycin (K051202)  |
|  1. Intended Use | See Item H.1 | Same  |
|  2. Technology | Microdilution MIC Susceptibility test; growth based result interpretation after 16 hours of incubation | Same  |
|  3. Result Reported | Report results as minimum inhibitory concentration (MIC) and categorical interpretation (SIR) | Same  |
|  4. Antibiotic | Vancomycin 0.25-128 μg/ml | Same  |
|  5. Read Methods | Manual and Automated | Same  |
|  6. Inoculation Methods | Turbidity and Prompt™ | Same  |
|  7. Instruments | autoSCAN® 4 or WalkAway® | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  1. MIC Interpretive Breakpoints | S≤2, I=4-8, R≥16 | S≤4, I=8-16, R≥32  |

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K. Standard/Guidance Document Referenced (if applicable):

Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test Systems; Guidance for Industry and FDA;

CLSI M7 (M100-S19) Performance Standards for Antimicrobial Susceptibility Testing; Nineteenth Informational Supplement

L. Test Principle:

After incubation in a non-CO2 incubator for 16-24 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth. The panels are read either manually using a touchSCAN® SR, or using either the WalkAway® or autoSCAN® instruments. The WalkAway® and autoSCAN® instruments both use an optics system in conjunction with growth algorithms to directly measure organism growth.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The scope of this particular submission is the evaluation of the antimicrobial agent vancomycin on the MicroScan Dried Gram-Positive MIC/Combo Panels utilizing the new, FDA approved, vancomycin breakpoint interpretative criteria (S≤2, I = 4-8, R≥16) for Staphylococcus aureus. Efficacy studies of both clinical and challenge isolates from the original 510(k), K051202, were re-evaluated using the new breakpoint interpretive criteria in order to assess device performance. No new clinical or analytical studies were conducted in support of this submission.

The reproducibility studies of the original 510(k) submission for the device, for all methods, was found to be >95% reproducible.

b. Linearity/assay reportable range:

Not applicable

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

The FDA and CLSI recommends the testing of Quality Control (QC) isolate, S.aureus ATCC 29213 to monitor and ensure the accuracy, precision and integrity of the supplies, reagents and drug used in the assay system, as well as the techniques of the individuals performing the test.

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The quality control results of the original 510(k), K051202, are listed in the table to follow. All results were read at 18 and 24 hours. The Prompt™ inoculation method in conjunction with the 24 hour readings for the S.aureus ATCC 29213, fall out-of-range on the high end, on several occasions. There was a recommendation made at that time that QC be read at 16-20 hours. This was mentioned as one reason why MicroScan® does not want to have all isolates read at 24 hours.

This 510(k) submission is for the evaluation of the antimicrobial agent vancomycin on the MicroScan Dried Gram-Positive MIC/Combo Panels using the new, FDA approved, vancomycin breakpoint interpretative criteria (S≤2, I = 4-8, R≥16) for Staphylococcus aureus. The expected range of S. aureus ATCC 29213 when tested in conjunction with vancomycin has not changed, therefore, a re-evaluation of the quality control data would provide no new information and is therefore not needed.

QC Table – Vancomycin (Data from original 510(k) Submission - K051202)

|  ORGANISM
S. aureus
ATCC 29213
Expected Range:
0.5 – 2 μg/ml | conc.
(μg/ml) | Ref.
Result | Turbidity Inoculation with Read
Methods |   |   |   |   |   | Prompt™ Inoculation with Read
Methods  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  Manual |   | Walk
Away® |   | auto
SCAN® |   | Manual |   | Walk
Away® |   | auto
SCAN®  |   |
|   |   |  | 18
hr | 24
hr | 18
hr | 24
hr | 18
hr | 24
hr | 18
hr | 24
hr | 18
hr | 24
hr | 18
hr | 24
hr  |
|   |  ≤0.25 |  |  |  |  |  |  |  |  |  |  |  |  |   |
|   |  0.5 | 1 |  |  |  |  |  |  |  |  |  |  |  |   |
|   |  1 | 89 | 67 | 45 | 75 | 47 | 82 | 52 | 25 | 15 | 29 | 15 | 31 | 17  |
|   |  2 | 7 | 27 | 49 | 16 | 45 | 9 | 40 | 66 | 71 | 63 | 73 | 63 | 26  |
|   |  4 |  |  |  |  |  | 1 |  |  | 6 |  | 5 |  | 2  |
|   |  8 |  |  |  |  |  |  |  |  |  |  |  |  |   |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |

d. Detection limit:
Not Applicable

e. Analytical specificity:
Not Applicable

f. Assay cut-off:
Not Applicable

{6}

2. Comparison studies:

a. Method comparison with predicate device:

This 510(k) application was submitted for the evaluation of vancomycin on the MicroScan Dried Gram Positive MIC/Combo Panel using the new FDA approved breakpoint interpretive criteria (S≤2, I=4-8, R≥16).

Performance data specific for the isolates of S.aureus from the original 510(k) submission, K051202, have been re-evaluated using the new interpretive criteria.

A total of 51 clinical isolates and 43 challenge isolates of S.aureus, representing MRSA, MSSA, and VRSA were re-evaluated. The results were compared to the reference method or expected results.

Table A below demonstrates the performance based on essential agreement and category agreement for the overall performance of the clinical and challenge isolates in combination with the turbidity method of inoculation and manual readings. Similar calculations for the different inoculation and reading methods were performed and show very little difference. These data are included in Tables B – F.

|  Table A. Turbidity/ Manual | Tot | EA N | %EA Total | Total Eval | EA Eval | %EA Eval | CA N | %CA | #R | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Clinical | 51 | 51 | 100 | 51 | 51 | 100 | 51 | 100 | 0 | 0 | 0 | 0  |
|  Challenge | 43 | 43 | 100 | 42 | 42 | 100 | 37 | 86 | 3 | 6 | 0 | 0  |
|  Combined | 94 | 94 | 100 | 93 | 93 | 100 | 88 | 93.6 | 3 | 6 | 0 | 0  |
|  Table B. Turbidity/ autoSCAN® | Tot | EA Total | %EA Total | Total Eval | EA Eval | %EA Eval | CA Total | %CA | #R | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Clinical | 51 | 51 | 100 | 51 | 51 | 100 | 51 | 100 | 0 | 0 | 0 | 0  |
|  Challenge | 43 | 42 | 97.7 | 42 | 41 | 97.6 | 38 | 88.4 | 3 | 5 | 0 | 0  |
|  Combined | 94 | 93 | 98.9 | 93 | 92 | 98.9 | 89 | 94.7 | 3 | 5 | 0 | 0  |
|  Table C. Turbidity/ WalkAway® | Tot | EA Total | %EA Total | Total Eval | EA Eval | %EA Eval | CA Total | %CA | #R | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Clinical | 51 | 51 | 100 | 51 | 51 | 100 | 51 | 100 | 0 | 0 | 0 | 0  |
|  Challenge | 43 | 43 | 100 | 42 | 42 | 100 | 37 | 86 | 3 | 6 | 0 | 0  |
|  Combined | 94 | 94 | 100 | 93 | 93 | 100 | 88 | 93.6 | 3 | 6 | 0 | 0  |

{7}

|  Table D. Prompt™/ Manual | Tot | EA Total | %EA Total | Total Eval | EA Eval | %EA Eval | CA Total | %CA | #R | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Clinical | 51 | 50 | 98 | 51 | 50 | 98 | 51 | 100 | 0 | 0 | 0 | 0  |
|  Challenge | 41 | 39 | 95.1 | 40 | 38 | 95 | 33 | 80.5 | 3 | 8 | 0 | 0  |
|  Combined | 92 | 89 | 96.7 | 91 | 88 | 96.7 | 84 | 91.3 | 3 | 8 | 0 | 0  |
|  Table E. Prompt™/ autoSCAN® | Tot | EA Total | %EA Total | Total Eval | EA Eval | %EA Eval | CA Total | %CA | #R | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Clinical | 51 | 50 | 98 | 51 | 50 | 98 | 51 | 100 | 0 | 0 | 0 | 0  |
|  Challenge | 41 | 41 | 100 | 40 | 40 | 100 | 33 | 80.5 | 3 | 8 | 0 | 0  |
|  Combined | 92 | 91 | 98.9 | 91 | 90 | 98.9 | 84 | 91.3 | 3 | 8 | 0 | 0  |
|  Table F. Prompt™/ WalkAway® | Tot | EA Total | %EA Total | Total Eval | EA Eval | %EA Eval | CA Total | %CA | #R | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Clinical | 51 | 50 | 98 | 51 | 50 | 98 | 51 | 100 | 0 | 0 | 0 | 0  |
|  Challenge | 41 | 39 | 95.1 | 40 | 38 | 95 | 33 | 80.5 | 3 | 8 | 0 | 0  |
|  Combined | 92 | 89 | 96.7 | 91 | 88 | 96.7 | 84 | 91.3 | 3 | 8 | 0 | 0  |

EA = Essential Agreement

$\mathbf{R} =$  Resistant Isolates

maj = major discrepancies

$\mathbf{CA} =$  Category Agreement

min = minor discrepancies

$\mathbf{v}\mathbf{m}\mathbf{j} =$  very major discrepancies

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 plus/minus one dilution. Essential Agreement (EA) occurs when there is agreement between the result of the reference method and that of MicroScan® within plus or minus one serial two-fold dilution of the antibiotic. Category Agreement (CA) occurs when the interpretation of the result of the reference method agrees exactly with the interpretation of the MicroScan® result.

Specifically related to the data of the challenge isolates tested, the percent Category Agreement (CA) falls consistently below the acceptance criteria of greater than or equal to  $90\%$ , as outlined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems Guidance. This is due to the low number of challenge isolates tested in conjunction with the occurrence of a number of minor discrepancies, due to the change in the breakpoint interpretive criteria. In each instance (with only one exception), the minor discrepancy fell within Essential Agreement (EA) of the reference method result. In each instance, if the minor discrepancies that fall within Essential Agreement are removed, the percent Category Agreement of the challenge data would fall well within the acceptance criteria of greater than or equal to  $90\%$ .

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The overall combined %EA and %CA consistently meet the acceptance criteria of greater than or equal to 90%.

The (3) tables below illustrate the clinical and challenge results that were in exact agreement with the reference method result and those that differed by one or more dilutions.

Table 1. S. aureus (MRSA) – Clinical (n=23) and Challenge (n=34/32) Results

|  Difference in the Number of Dilutions between the Reference Result and the MicroScan® Result – S.aureus (MRSA) with Vancomycin  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Inoculation Method | Read Method | > Minus 2 Dilutions | Minus 1 Dilution | Exact Agreement | Plus 1 Dilution | > Plus 2 Dilutions  |
|  Turbidity | Manual |  | 2 | 49 | 6 |   |
|  Turbidity | autoSCAN® 4 | 1 | 3 | 49 | 4 |   |
|  Turbidity | WalkAway® |  | 2 | 47 | 7 |   |
|  Prompt | Manual |  |  | 25 | 30 |   |
|  Prompt | autoSCAN® 4 |  | 1 | 27 | 27 |   |
|  Prompt | WalkAway® |  | 1 | 23 | 31 |   |
|  TOTAL |  | 1 | 9 | 220 | 105 |   |

Table 2. S. aureus (MSSA) – Clinical (n=28) and Challenge (n=6) Results

|  Difference in the Number of Dilutions between the Reference Result and the MicroScan® Result – S.aureus (MSSA) with Vancomycin  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Inoculation Method | Read Method | > Minus 2 Dilutions | Minus 1 Dilution | Exact Agreement | Plus 1 Dilution | > Plus 2 Dilutions  |
|  Turbidity | Manual |  | 2 | 30 | 2 |   |
|  Turbidity | autoSCAN® 4 |  | 3 | 31 |  |   |
|  Turbidity | WalkAway® |  | 2 | 30 | 2 |   |
|  Prompt | Manual |  | 2 | 12 | 19 | 1  |
|  Prompt | autoSCAN® 4 |  | 2 | 14 | 17 | 1  |
|  Prompt | WalkAway® |  | 2 | 10 | 21 | 1  |
|  TOTAL |  |  | 13 | 127 | 59 | 3  |

Table 3. S. aureus (VRSA) Challenge (n=3) Results

|  Difference in the Number of Dilutions between the Reference Result and the MicroScan® Result – S.aureus (VRSA) with Vancomycin  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Inoculation Method | Read Method | > Minus 2 Dilutions | Minus 1 Dilution | Exact Agreement | Plus 1 Dilution | > Plus 2 Dilutions  |
|  Turbidity | Manual |  |  | 1 | 2 |   |
|  Turbidity | autoSCAN® 4 |  | 1 | 2 |  |   |
|  Turbidity | WalkAway® |  |  | 1 | 2 |   |
|  Prompt | Manual |  |  | 1 |  | 2  |
|  Prompt | autoSCAN® 4 |  |  | 2 | 1 |   |
|  Prompt | WalkAway® |  |  | 1 |  | 2  |
|  TOTAL |  |  | 1 | 8 | 5 | 4  |

There is a trend of the MicroScan® towards more resistant reading in comparison to the reference method (i.e. more values in the "Plus" category). This is even more pronounced when the Prompt™ method of inoculation is used, but still an EA of greater than 95% is achieved with all read methods. The trends of more resistant reading in

{9}

general, and more resistant results for the Prompt™ method of inoculation are consistent with the findings of the original 510(k) submission (K051202).

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 interpretive criteria (μg/ml):
≤2 (S), 4-8 (I), ≥16 (R)

The interpretive criteria and quality control ranges are the same as recommended in the FDA approved pharmaceutical package insert and the CLSI. These 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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT/K091264](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT/K091264)

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