← Product Code [LON](/productcode/LON) · K192110

# Vitek Densichek (K192110)

_bioMerieux, Inc. · LON · Oct 31, 2019 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K192110

## Device Facts

- **Applicant:** bioMerieux, Inc.
- **Product Code:** [LON](/productcode/LON.md)
- **Decision Date:** Oct 31, 2019
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1645
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The VITEK®DENSICHEK® instrument is an accessory intended for use with the VITEK® 2 Systems to measure the optical density of a microorganism suspension. The instrument provides values in McFarland units, proportional to the microorganism concentration. VITEK® is intended for use with polystyrene tubes, and the reading range is 0.00 to 4.00 McFarland. The VITEK® DENSICHEK® has applications as an in vitro diagnostic medical device, or in an industry setting.

## Device Story

VITEK DENSICHEK is an optical reading accessory for VITEK 2 systems; measures turbidity of microorganism suspensions in polystyrene tubes. Device consists of a Pod (optical interface) and a Base unit (Display or Connectivity). Pod uses 635 nm LED to measure light absorption; algorithm converts turbidimetric readings to McFarland units. Pod transmits data via Bluetooth Low Energy to Base; Base displays results on LCD resistive touch screen and integrates with VITEK 2 software for traceability. Used by laboratory professionals in clinical or industry settings. Provides standardized McFarland values to ensure accurate inoculum concentration for antimicrobial susceptibility testing; improves workflow via automated data transmission and RFID-tagged reference standards for verification.

## Clinical Evidence

Bench testing only. Reproducibility studies across three sites using Gram-negative, Gram-positive, and yeast isolates demonstrated >95% reproducibility for both automatic and manual dilution methods. Repeatability testing across six McFarland ranges (0.2 to 3.69) showed >95% accuracy. QC performance for various AST cards (GN69, GP72, ST02, YS05) consistently met >95% in-range criteria. Comparison of modal MIC values between subject and predicate devices showed 85.5% exact match and 98.9% within +/- one dilution.

## Technological Characteristics

Optical turbidimetric reader; 635nm LED light source; photodiode detector. Components: Pod (optical interface), Display/Connectivity Base, McFarland Reference Kit. Connectivity: Bluetooth Low Energy (BTLE) between Pod and Base; USB power. Standards: UL 61010-1 (electrical safety), EN 62471 (photobiological safety). Software: Algorithm-based turbidimetric calculation. Sterilization: Not applicable (non-sterile accessory).

## 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

- DensiCHEK® Plus ([K083536](/device/K083536.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/).

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K192110

B Applicant

bioMerieux, Inc

C Proprietary and Established Names

Vitek Densichek

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  LON | Class II | 21 CFR 866.1645 - Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System | MI - Microbiology  |

K192110 - Page 1 of 15

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## II Submission/Device Overview:

### A Purpose for Submission:
To add an accessory instrument for use with the VITEK 2 and VITEK 2 Compact Systems

### B Type of Test:
Growth based

## III Intended Use/Indications for Use:

### A Intended Use(s):
See Indications for Use below.

### B Indication(s) for Use:
The VITEK DENSICHEK instrument is an accessory intended for use with the VITEK 2 Systems to measure the optical density of a microorganism suspension. The instrument provides values in McFarland units, proportional to the microorganism concentration. VITEK DENSICHEK is intended for use with polystyrene tubes, and the reading range is 0.00 to 4.00 McFarland. The VITEK DENSICHEK has applications as an in vitro diagnostic medical device, or in an industry setting.

### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

## IV Device/System Characteristics:

### A Device Description:
The VITEK DENSICHEK is an optical reading device intended for professional use by laboratory health professionals in clinical or industry laboratory settings. The device determines the McFarland value by evaluating the absorption of light in the test tube

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containing the suspension. The more turbid the organism suspension is, the higher the McFarland value displayed by the device. An algorithm assesses results obtained from the turbidimetric reading and translates them into a McFarland value.

The VITEK DENSICHEK instrument contains a base unit with a detachable optical interface, named the Pod. The Pod calculates and automatically transmits the optical McFarland reading to the Base unit for display. The user can confirm the McFarland value by pressing a button on the Pod, optionally saving the value to the VITEK FLEXPREP Software on a laboratory PC, where it is recorded with specimen setup information for traceability.

The Pod McFarland readings are communicated to the Base through a Bluetooth Low Energy wireless interface. When docked on a Base, the Pod is automatically paired and recharged through a wireless contact connection. The Display Base displays McFarland readings from the Pod on an LCD resistive touch screen and can be integrated with VITEK 2 software to record readings for traceability. The Connectivity Base is available for customers who only want to use the VITEK DENSICHEK with the VITEK 2 software to display and record McFarland readings. McFarland Reference Standards featuring radio-frequency identification (RFID) tags are used to verify the measurement accuracy performance of the VITEK DENSICHEK.

B Instrument Description Information:

|  Modes of Operation | Yes | No  |
| --- | --- | --- |
|  Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? | ☑ | ☐  |
|  Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? | ☑ | ☐  |
|  Software  |   |   |
|  FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types. | ☑ | ☐  |

1. Instrument Name:
VITEK DENSICHEK

2. Specimen Identification:
N/A

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3. Specimen Sampling and Handling:

N/A

4. Calibration:

Instrument verification is performed using one or more of the McFarland standards (0.5, 2.0, or 3.0) after zeroing the instrument with the 0.0 McFarland Standard blank. These standards are packaged for use with the VITEK DENSICHEK instrument.

5. Quality Control:

Routine reference checks prior to use, on a monthly basis, and after cleaning

V Substantial Equivalence Information:

A Predicate Device Name(s):

DensiCHEK Plus

B Predicate 510(k) Number(s):

K083536

C Comparison with Predicate(s):

|  Device & Predicate Device(s): | Device: K192110 | Predicate: K083536  |
| --- | --- | --- |
|  Device Trade Name | VITEK DENSICHEK | DENSICHEK PLUS  |
|  General Device Characteristic Similarities |  |   |

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|  Intended Use/Indications For Use | Intended for use with the VITEK 2 Systems to measure the optical density of a microorganism suspension. The instrument provides values in McFarland units, proportional to the microorganism concentration. | Same  |
| --- | --- | --- |
|  Sample Type | Microorganism suspension in saline | Same  |
|  Type of Test | Growth based | Same  |
|  Modes of Operation | Manual, only one test tube can be read with VITEK DENSICHEK at a time. | Same  |
|  Method of Testing | Designed to measure the optical density of microorganism suspended in a liquid medium and convert that optical density into a McFarland value | Same  |
|  Reading Range | 0.00 to 4.00 McFarland | Same  |
|  Light Source | Light Emitting Diode | Same  |
|  Calibration Verification | Instrument verification is performed using one or more of the McFarland standards (0.5, 2.0, or 3.0) after zeroing the instrument with the 0.00 McFarland Standard blank | Same  |
|  General Device Characteristic Differences |  |   |
|  Instrument Components | VITEK DENSICHEK Pod
VITEK DENSICHEK
Display Base | DENSICHEK Plus
DENSICHEK Plus
Standards Kit  |

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|   | VITEK DENSICHEK
Connectivity Base
VITEK DENSICHEK
McFarland Reference Kit |   |
| --- | --- | --- |
|  Test Tubes | Polystyrene test tubes only | Glass or polystyrene test tubes  |
|  Calibration verification | Do not have to change tube mode, RFID technology | Manual change of tube mode  |
|  Interface with PC | Communication with any configured PC running bioMerieux supplied interface software | Not Applicable  |
|  Power Source | Capable of running on A/C power source; rechargeable lithium ion polymer battery | 4 AAA batteries, either alkaline or nickel-metal hydride (NIMH)  |
|  Light Source | LED is 635 nm | LED is 580 nm  |
|  Radio Communication | Bluetooth Low Energy and Radiofrequency identification | Not Applicable  |

VI Standards/Guidance Documents Referenced:

- Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009.
- CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 28th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2018.
- CLSI M7-A10: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition

K192110 - Page 6 of 15

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- IEC 61010-1: 2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
- IEC 62471: 2006 Photobiological safety of lamps and lamp systems

## VII Performance Characteristics (if/when applicable):

### A Analytical Performance:

#### 1. Precision/Reproducibility:

Three reproducibility studies were conducted to demonstrate the performance of the VITEK DENSICHEK. The first study (Study 1) evaluated the original design which is referred to as Product Build 1 (PB1). Study 1 was conducted in which both the predicate, DensiCHEK Plus, and PB1 were evaluated. A panel of 10 Gram-negative isolates, 10 Gram-positive isolates, and 10 yeast isolates were used to prepare the suspension, which was used to inoculate each antimicrobial within each test card (i.e., AST-GN69, AST-GP72, AST-ST02, AST-YS05). Both dilution options (automatic and manual dilutions) were used to inoculate AST cards noted below. Testing was conducted at three sites across three days for a total of 540 results per antimicrobial (3 x 2 x 3 x 3 x 10 = 540) using the following test cards with respective antimicrobials:

AST-GN69 (Gram-negative)
Ampicillin
Amoxicillin/Clavulanic Acid
Ceftazidime
Gentamicin
Imipenem
Levofloxacin
Trimethoprim/Sulfamethoxazole

AST-GP72 (Gram-positive)
Ampicillin
Chloramphenicol
Ciprofloxacin
Daptomycin

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Nitrofurantoin

Minocycline

AST-ST02 (Gram-positive)

Benzylpenicillin

Erythromycin

Tetracycline

AST-YS05 (Yeast)

Caspofungin

Fluconazole

Reproducibility data was analyzed taking into consideration best case and worst-case analysis as described in the AST Special Controls Guidance Document. As shown in Tables 2 and 3, the best-case reproducibility for all drugs for both automatic and manual dilution methods was  $>95\%$ . The drugs that demonstrated  $<95\%$  reproducibility for worst case included isolates that were off-scale when compared to the mode of each isolate (e.g., result  $\leq 2$ , mode  $= 4$ ), however, given that the majority of the worst-case results were  $>95\%$  for all drugs and  $>95\%$  for all best-case results, they were deemed acceptable.

Table 2: Reproducibility Results Using Automatic Dilution using the VITEK 2 for Product Build 1

|  Card | Antimicrobial | Best Case (%) | Worst Case (%)  |
| --- | --- | --- | --- |
|  AST-GN69 | Ampicillin | 100 | 99.26  |
|   |  Amoxicillin/Clavulanic Acid | 100 | 92.96*  |
|   |  Ceftazidime | 100 | 100  |
|   |  Gentamicin | 100 | 100  |
|   |  Imipenem | 100 | 100  |
|   |  Levofloxacin | 100 | 100  |
|   |  Trimethoprim/Sulfamethoxazole | 98.89 | 90.37*  |
|  AST-GP72 | Ampicillin | 99.63 | 97.78  |
|   |  Chloramphenicol | 100 | 99.63  |
|   |  Ciprofloxacin | 100 | 98.15  |
|   |  Daptomycin | 98.52 | 98.52  |
|   |  Nitrofurantoin | 100 | 100  |

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Table 3: Reproducibility Results Using Manual Dilution using the VITEK 2 Compact for Product Build 1

|  Card | Antimicrobial | Best Case | Worst Case  |
| --- | --- | --- | --- |
|  AST-GN69 | Ampicillin | 99.63 | 98.89  |
|   |  Amoxicillin/Clavulanic Acid | 99.63 | 93.70*  |
|   |  Ceftazidime | 100 | 99.63  |
|   |  Gentamicin | 100 | 100  |
|   |  Imipenem | 97.78 | 97.78  |
|   |  Levofloxacin | 100 | 100  |
|  AST-GP72 | Trimethoprim/Sulfamethoxazole | 98.89 | 91.11*  |
|   |  Ampicillin | 99.26 | 96.67  |
|   |  Chloramphenicol | 100 | 98.89  |
|   |  Ciprofloxacin | 100 | 96.30  |
|   |  Daptomycin | 99.63 | 99.63  |
|   |  Nitrofurantoin | 100 | 100  |
|   |  Minocycline | 99.26 | 89.26*  |
|  AST-ST02 | Vancomycin | 99.63 | 99.63  |
|   |  Benzylpenicillin | 99.26 | 99.26  |
|   |  Erythromycin | 98.15 | 48.15*  |
|  AST-YS05 | Tetracycline | 100 | 46.67*  |
|   |  Caspofungin | 100 | 78.52*  |
|   |  Fluconazole | 98.89 | 85.56*  |

*Included results that were off-scale.

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After Study 1 was completed, a minor design change involving the spring torsion allowing tube rotation was made to PB1 to improve repeatability. The modified, final device was referred to as Product Build 2 (PB2). Two additional studies (see below) were conducted to evaluate reproducibility of PB2.

Study 2 was conducted at an internal site to demonstrate equivalency between the PB1 and PB2 to assess the impact of this design change. The same isolates and antimicrobials were tested for both automatic and manual dilution methods for PB2 and the results were compared to both PB1 and DensiCHEK Plus. Overall, the mode MIC values obtained using inocula prepared with VITEK DENSICHEK PB1 and VITEK DENSICHEK PB2 and Densicheck Plus (predicate) were compared. Modal MIC results were an exact match  $89.5\%$  of the time and were within  $+/-$  one dilution of each other  $99.5\%$  of the time between PB1 and PB2 (Table 4). Also, the mode MIC values were an exact match  $85.5\%$  of the time and were within  $+/-$  one dilution of each other  $98.9\%$  of the time between PB2 and DensiCHEK Plus (Table 5). Results for both analyses indicated that each device tested were comparable.

Table 4: Comparison of Modes Between PB1 and PB2

|  Dilution Method | Dilution Difference |   |   |   |   | Within +/- 1 Dilution  |
| --- | --- | --- | --- | --- | --- | --- |
|   |  ≤ -2 (%) | -1 (%) | 0 (%) | +1 (%) | ≥ +2 (%)  |   |
|  Automatic | 0 (0) | 12 (6.3) | 172 (90.5) | 6 (3.2) | 0 (0)_ | 190/190 (100)  |
|  Manual | 0 (0) | 11 (5.8) | 168 (88.4) | 9 (4.7) | 2 (1.1) | 188/190 (98.9)  |
|  Combined | 0 (0) | 23 (6.1) | 340 (89.5) | 15 (3.9) | 2 (0.5) | 378/380 (99.5)  |

Table 5: Comparison of Modes Between PB2 and DensiCHEK Plus

|  Dilution Method | Dilution Difference |   |   |   |   | Within +/- 1 Dilution  |
| --- | --- | --- | --- | --- | --- | --- |
|   |  ≤ -2 (%) | -1 (%) | 0 (%) | +1 (%) | ≥ +2 (%)  |   |
|  Automatic | 2 (1.1) | 23 (12.1) | 160 (84.2) | 5 (2.6) | 0 (0) | 188/190 (98.9)  |
|  Manual | 2 (1.1) | 20 (10.5) | 165 (86.8) | 3 (1.6) | 0 (0) | 188/190 (98.9)  |
|  Combined | 4 (1.1) | 43 (11.3) | 325 (85.5) | 8 (2.1) | 0 (0) | 376/380 (98.9)  |

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Another reproducibility study (Study 3) was conducted with an additional 10-organism panel to assess reproducibility at three sites (two external clinical sites and one internal site). Reproducibility isolates were tested using the appropriate VITEK 2 AST card at each clinical trial site. The reproducibility sets were tested in triplicate on each of three days by VITEK 2 automatic dilution and VITEK 2 Compact manual dilution using 11 antimicrobials with McFarland suspensions prepared using the VITEK DENSICHEK PB 2 for a total of 108 results for each antimicrobial. Testing was performed using Greiner Bio-One polystyrene test tubes for VITEK 2. VITEK DENSICHEK PB 2 met the reproducibility performance criteria of >95% across all sites and therefore, acceptable.

2. Linearity:
Not applicable

3. Analytical Specificity/Interference:
Not applicable

4. Accuracy (Instrument):
See section B for supportive information.

5. Carry-Over:
Not applicable

B Other Supportive Instrument Performance Characteristics Data:

Quality Control – VITEK 2 and VITEK 2 Compact Systems

Eight QC organisms were tested in Study 1 using Product Build 1 of the VITEK DENSICHEK and the VITEK 2 AST card at each clinical trial site. The organisms tested were:

E. coli ATCC 25922
P. aeruginosa ATCC 27853

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E. coli ATCC 35218

E. faecalis ATCC 29212

S. aureus ATCC 29213

S. pneumoniae ATCC 49619

C. parapsilosis ATCC 22019

C. krusei ATCC 6528

A minimum of 20 replicates for each QC organism were collected without exceeding five replicates per day for each site (i.e., at least 60 results/drug), using a suspension prepared using the DENSICHEK Plus and a separate suspension prepared using the VITEK DENSICHEK PB1. Testing was performed using the VITEK 2 and VITEK 2 Compact Systems. The VITEK DENSICHEK PB1 demonstrated acceptable QC performance of >95% (Table 6) for isolates tested with Gram-negative, Gram-positive, Streptococcus, and Yeast AST cards and was therefore, deemed acceptable.

Table 6: Summary of QC Performance for Study 1 (PB1)

|  VITEK 2 AST-GN69 | E. coli ATCC 25922  |   |
| --- | --- | --- |
|   |  VITEK 2 | VITEK 2 Compact  |
|   |  % in Range | % in Range  |
|  Amoxicillin/Clavulanic Acid | 100 | 100  |
|  Ampicillin | 100 | 100  |
|  Ceftazidime | 100 | 100  |
|  Gentamicin | 100 | 100  |
|  Imipenem | 100 | 100  |
|  Levofloxacin | 100 | 100  |
|  Trimethoprim/sulfamethoxazole | 100 | 100  |
|  VITEK 2 AST-GN69 | P. aeruginosa ATCC 27853  |   |
|  Ceftazidime | 100 | 100  |
|  Gentamicin | 100 | 100  |
|  Imipenem | 100 | 100  |
|  Levofloxacin | 100 | 100  |
|  Trimethoprim/sulfamethoxazole | 100 | 100  |
|  VITEK 2 AST-GN69 | E. coli 35218  |   |
|  Amoxicillin/clavulanic Acid | 100 | 100  |
|  VITEK 2 AST-GP72 | E. faecalis ATCC 29212  |   |

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K192110 - Page 13 of 15
|   | VITEK 2 | VITEK 2 Compact  |
| --- | --- | --- |
|   | % in Range | % in Range  |
|  Ampicillin | 100 | 100  |
|  Chloramphenicol | 100 | 100  |
|  Ciprofloxacin | 100 | 100  |
|  Daptomycin | 100 | 98.3  |
|  Nitrofurantoin | 100 | 100  |
|  Minocycline | 100 | 100  |
|  Vancomycin | 100 | 100  |
|  VITEK 2 AST-GP72 | S. aureus ATCC 29213  |   |
|  Chloramphenicol | 100 | 100  |
|  Ciprofloxacin | 100 | 100  |
|  Daptomycin | 100 | 100  |
|  Nitrofurantoin | 100 | 100  |
|  Minocycline | 100 | 100  |
|  Vancomycin | 100 | 100  |
|  VITEK 2 AST-ST02 | S. pneumoniae ATCC 49619  |   |
|   | VITEK 2 | VITEK 2 Compact  |
|   | % in Range | % in Range  |
|  Benzylpenicillin | 100 | 100  |
|  Erythromycin | 100 | 100  |
|  Tetracycline | 100 | 100  |
|  VITEK 2 AST-YS05 | C. parapsilosis ATCC 22019  |   |
|   | VITEK 2 | VITEK 2 Compact  |
|   | % in Range | % in Range  |
|  Caspofungin | 100 | 100  |
|  Fluconazole | 100 | 100  |
|   | C. krusei ATCC 6528  |   |
|  Caspofungin | 100 | 100  |
|  Fluconazole | 100 | 100  |

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QC testing was also conducted for VITEK DENSICHEK PB 2 for both the VITEK 2 and VITEK 2 Compact instruments for the same drugs and QC organisms at one site (i.e., 20 per drug/organism combination). Results were acceptable at >95%.

The sponsor also conducted the following microbiological verification studies:

## Repeatability

Repeatability testing on the subject device was based on multiple dilutions of one suspension of ATCC *E. coli* 25922 suspended in 0.45% saline. The dilutions were confirmed to be within the appropriate CFU ranges equivalent for each McFarland target using a calibrated spectrophotometer and colony count testing. A total of 270 results (10 devices x 9 tubes x 3 lots of Greiner 12x75 polystyrene tubes) for each the subject and predicate devices across six McFarland ranges (i.e., 0.2, 0.5, 1, 2, 3, and 3.69 McFarland = 3240 results) was evaluated for accuracy. All results fell within the appropriate McFarland ranges >95% of the time and were acceptable.

## AST Verification and Supplemental QC Testing

The sponsor tested a variety of available isolates with internally validated QC ranges. Testing was done across three different subject devices and the one predicate device to ensure that the McFarland readings were producing accurate results according to their validated QC ranges. The following drugs were tested 59 times using the AST-GN69 card (Gram-negative isolates) with each of the devices (i.e., 177 results) with the exception of piperacillin/tazobactam which was tested 57 (i.e., 174 results) times with each: amoxicillin/clavulanic acid, ampicillin, ampicillin/sulbactam, cefazolin, cefepime, ceftazidime, ceftriaxone, ciprofloxacin, ESBL screen, ertapenem, gentamicin, imipenem, levofloxacin, nitrofurantoin, piperacillin/tazobactam, tobramycin, and trimethoprim/sulfamethoxazole. For these isolates tested, the overall QC results for the VITEK DensiCHEK indicated that the devices were performing acceptably at >95% within range. When evaluated separately, performance for nitrofurantoin was 89.3% (158/177), however, given the combined performance for all drugs was >95%, the overall performance was considered acceptable.

The following drugs were tested 64 times using the AST-GP67 card (Gram-positive isolates) with each of the three subject devices: ampicillin, benzypenicillin, cefoxitin, ciprofloxacin, clindamycin, erythromycin, gentamicin, gentamicin high-level synergy, inducible-clindamycin resistance, levofloxacin, linezolid, moxifloxacin, nitrofurantoin, oxacillin, quinupristin/dalfopristin, rifampicin, streptomycin high-level synergy, tetracycline, tigecycline, trimethoprim/sulfamethoxazole, and vancomycin. For these isolates tested, the overall QC results indicated that the devices were performing acceptably at >95% within range.

The following drugs were tested 53 times using the AST-ST02 card (Streptococcus spp. isolates) with each of the three subject devices: ampicillin, benzypenicillin, cefotaxime, ceftriaxone, clindamycin, erythromycin, inducible-clindamycin resistance,

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levofloxacin, linezolid, moxifloxacin, tetracycline, tigecycline, trimethoprim/sulfamethoxazole, and vancomycin. For these isolates tested, the overall QC results indicated that the devices were performing acceptably at >95% within range.

The following drugs were tested 36 times using the AST-YS07 card (Candida spp. isolates) with each of the three subject devices: amphotericin B, caspofungin, fluconazole, flucytosine, micafungin, and voriconazole. For these isolates tested, the overall QC results indicated that the devices were performing acceptably at >95% within range.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

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

K192110 - Page 15 of 15

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**Source:** [https://fda.innolitics.com/device/K192110](https://fda.innolitics.com/device/K192110)

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