(87 days)
No
The description mentions an "algorithm" to translate turbidimetric readings into a McFarland value, but there is no indication of AI/ML techniques like training data, neural networks, or learning processes. The function appears to be a straightforward calculation based on light absorption.
No.
The device is used to measure the optical density of microorganism suspensions, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states: "The VITEK® DENSICHEK® has applications as an in vitro diagnostic medical device".
No
The device description clearly lists multiple hardware components including a Pod, Display Base, Connectivity Base, McFarland Reference Kit, and USB Power Adaptor. It is described as an "optical reading device."
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The VITEK® DENSICHEK® has applications as an in vitro diagnostic medical device, or in an industry setting."
- Function: The device measures the optical density of a microorganism suspension to determine its concentration in McFarland units. This is a standard procedure in clinical microbiology laboratories for preparing inoculums for susceptibility testing, which is a key part of in vitro diagnostics.
- User and Setting: The intended user is "professional use by laboratory health professionals in clinical or industry laboratory settings." Clinical laboratories are where IVD devices are typically used.
- Accessory to an IVD System: It is an accessory intended for use with the VITEK® 2 Systems, which are themselves IVD systems used for microbial identification and susceptibility testing.
While it also has applications in an industry setting, its stated intended use as an "in vitro diagnostic medical device" and its function within a clinical laboratory workflow clearly classify it as an IVD.
N/A
Intended Use / 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 concentrations. 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.
Product codes
LON
Device Description
The VITEK® DENSICHEK® consists of the following accessories and components:
- . VITEK® DENSICHEK® Pod
- VITEK® DENSICHEK® Display Base ●
- VITEK® DENSICHEK® Connectivity Base ●
- . VITEK® DENSICHEK® McFarland Reference Kit
- USB Power Adaptor .
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 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, 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 (BTLE) 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®.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical reading
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use by laboratory health professionals in clinical or industry laboratory settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Studies
The Premarket Notification (510[k]) presents data in support of VITEK® DENSICHEK®. The purpose of this study/trial is to evaluate the reproducibility performance of the VITEK® device as used with the VITEK®2 and VITEK®2 Compact Systems in a clinical setting.
Study 1
Study type: Reproducibility and Quality Control Performance Evaluation
Sample size: Not specified (tested with Gram-negative, Gram-positive, Streptococus, and Yeast AST card types)
Key results: The VITEK® DENSICHEK® demonstrated acceptable quality control performance of >95% and reproducibility for isolates tested with Gram-negative, Gram-positive, Streptococus, and Yeast AST card types. Overall quality control and reproducibility performance was acceptable.
Study 2
Study type: Equivalency Study (to validate the equivalence of VITEK® DENSICHEK® Product Build 1, and the VITEK® DENSICHEK® Product Build 2)
Sample size: Not specified (190 for Auto, 190 for Manual, 380 for Combined based on dilution differences)
Key results: The exact agreement rate was nearly 90.0%, and the essential agreement rate was 99.5%. The combined reproducibility rates for both product builds differ by no more than 0.4%, overall, for both best and worst case. The observed level of agreement between modes indicates that both product builds are associated with results that occur at a similar location on the MIC scale. The small difference in reproducibility rates provides evidence that AST result variability is nearly identical for both PB1 and PB2. The best-case reproducibility was acceptable for all drugs evaluated.
Study 3
Study type: Abbreviated Reproducibility Study (to assess the performance of the VITEK® DENSICHEK® Product Build 2 when end-user variability was introduced)
Sample size: Not specified (380 for combined based on dilution differences)
Data source: Subset of internal data and data collected at two external sites
Key results: VITEK® DENSICHEK® Product Build 2 met the performance criteria of >95% across all sites reproducibility with no observed exceptions. From the comparison of modes, the agreement rate within ± 1 doubling dilution is nearly 99% indicating a high level of correlation between results from the two devices. For the comparison of reproducibility rates, the differences are small for both dilution methods.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: 99.5% (Study 2, Combined), 98.9% (Study 3, Auto), 98.9% (Study 3, Manual), 98.9% (Study 3, Combined)
Exact Agreement: nearly 90.0% (Study 2)
Reproducibility Rate: >95% (Study 1), Combined 99.4% (PB1) and 99.0% (PB2) (Study 2), >95% (Study 3)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
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.(b)
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.”
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 31, 2019
bioMerieux, Inc. Nathan Hardesty Sr. Manager, Regulatory Affairs 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K192110
Trade/Device Name: VITEK DENSICHEK Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON Dated: August 2, 2019 Received: August 5, 2019
Dear Nathan Hardesty:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192110
Device Name VITEK DENSICHEK
Indications for Use (Describe)
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 concentrations. 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with the top half being blue and the bottom half being yellow-green. The company name, "BIOMÉRIEUX", is written in white, sans-serif font across the center of the circle, positioned on the blue portion.
510(k) SUMMARY
VITEK® DENSICHEK®
A. 510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jennifer Jines |
| Phone Number: | 314-731-8352 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | August 2, 2019 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® DENSICHEK® |
| Regulation Section: | 21 CFR 866.1645 |
| Classification Name: | Fully Automated Short-Term Incubation Cycle Antimicrobial |
| Susceptibility System |
LON
Microbiology
VITEK® DENSICHEK®
Common Name:
C. Predicate Device:
Panel:
Product Code:
| Predicate Device Name: | DensiCHEK® Plus |
|---|---|
| ------------------------ | ----------------- |
Predicate Device Number: K083536
D. 510(k) Summary:
E. Intended 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.
F. Test Principle:
The VITEK® DENSICHEK® instrument is designed for use with the VITEK® 2 Systems to measure the optical density of a microorganism suspension. The instrument provides values in McFarland units,
4
proportional to the microorganism concentrations. It is intended for use with the VITEK® 2 Systems during the inoculum preparation phase of the Identification (ID) and Antimicrobial Susceptibility Test (AST) card testing process.
The VITEK®DENSICHEK® generates a McFarland value using basic colorimetry, which is a method of measurement that relates the amount of color in a transparent medium (liquid) to the amount of a particular substance in the liquid. In general the concentration of the substance being measured is proportional to the intensity of the solution. The darker the color becomes, the higher the concentration.
The VITEK® DENSICHEK® measures the turbidity of the saline and microorganism suspension using a single wavelength, 635nm, light emitting diode (LED). The absorption of light determines the McFarland value measured by the instrument. The more turbid the suspension, the higher the McFarland measurement reported by the device. The light source in the VITEK® emits a narrow range of wavelengths, which pass through the test tube containing the measured suspension and into a photodiode detector. The instrument is first zeroed using a test tube filled with saline (blank). The technician then places the well-mixed organism suspension into the instrument and slowly rotates the test tube. The instrument will display a series of dashes followed by a McFarland reading, based on the amount of energy that was detected at the photodiode.
G. Device Description:
The VITEK® DENSICHEK® consists of the following accessories and components:
- . VITEK® DENSICHEK® Pod
- VITEK® DENSICHEK® Display Base ●
- VITEK® DENSICHEK® Connectivity Base ●
- . VITEK® DENSICHEK® McFarland Reference Kit
- USB Power Adaptor .
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 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, 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 (BTLE) 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®.
5
H. FDA Recognized Consensus Standards Referenced:
- M100S, "Performance Standards for Antimicrobial Susceptibility Testing, 28th Edition", . 28th Edition (January 2018)
- M07-A10. " Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard - Tenth Edition," Vol. 35 No.2 (January 2015)
- . UL 61010-1: 2012 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
- EN 62471: 2008 Photobiological safety of lamps and lamp systems ●
l. Performance Characteristics:
Clinical Studies
The Premarket Notification (510[k]) presents data in support of VITEK® DENSICHEK®. The purpose of this study/trial is to evaluate the reproducibility performance of the VITEK® device as used with the VITEK®2 and VITEK®2 Compact Systems in a clinical setting.
Study 1
The purpose of Study 1 was to evaluate the reproducibility and quality control performance of the VITEK® DENSICHEK® device as used with the VITEK® 2 and VITEK® 2 Compact Systems in a clinical setting. Data was collected using VITEK® DENSICHEK® and the DensiCHEK® Plus. The VITEK® DENSICHEK® demonstrated acceptable quality control performance of >95% and reproducibility for isolates tested with Gram-negative, Gram-positive, Streptococus, and Yeast AST card types. There were no exceptions for this performance data. As such, the overall quality control and reproducibility performance of VITEK® DENSICHEK® was acceptable.
Study 2
The purpose of Study 2 was an Equivalency Study to validate the equivalence of VITEK® DENSICHEK® Product Build 1, and the VITEK® DENSICHEK® Product Build 2. Reproducibility data was collected using both product builds and the performance of the VITEK® DENSICHEK® Product Build 1 was compared to the performance of the VITEK® DENSICHEK® Product Build 2.
The table below shows the distribution of two-fold dilution differences between modes by dilution method and combined. For this overall comparison, any strain / antimicrobial combination having a mode that was offscale was ignored. The rationale for this is that variation between modes can be measured more accurately using only on-scale organisms.
| Dilution Method | Dilution Difference | Essential Agreement | ||||
|---|---|---|---|---|---|---|
| ≤-2 | -1 | 0 | +1 | ≥ +2 | ||
| Auto | 0 | |||||
| 0.0% | 12 | |||||
| 6.3% | 172 | |||||
| 90.5% | 6 | |||||
| 3.2% | 0 | |||||
| 0.0% | 190 / 190 | |||||
| 100.0% | ||||||
| Manual | 0 | |||||
| 0.0% | 11 | |||||
| 5.8% | 168 | |||||
| 88.4% | 9 | |||||
| 4.7% | 2 | |||||
| 1.1% | 188 / 190 | |||||
| 98.9% | ||||||
| Combined | 0 | |||||
| 0.0% | 23 | |||||
| 6.1% | 340 | |||||
| 89.5% | 15 | |||||
| 3.9% | 2 | |||||
| 0.5% | 378 / 380 | |||||
| 99.5% |
Distribution of Dilution Differences Between Product Build Modes ( PB2 - PB1)
6
The table below provides a summary of the overall reproducibility rates by dilution method and combined for each product build.
| Dilution | Best Case | Worst Case | ||||
|---|---|---|---|---|---|---|
| Method | Product | |||||
| Build 1 | Product | |||||
| Build 2 | Difference | Product | ||||
| Build 1 | Product | |||||
| Build 2 | Difference | |||||
| Auto | 99.8% | 99.4% | 0.4% | 98.9% | 98.6% | 0.3% |
| Manual | 99.0% | 98.5% | 0.5% | 98.0% | 97.6% | 0.4% |
| Combined | 99.4% | 99.0% | 0.4% | 98.4% | 98.0% | 0.4% |
Overall Reproducibility Rate Comparison
The overall comparison of modes between the two product builds reveals that the exact agreement rate was nearly 90.0%, and the essential agreement rate was 99.5%. Furthermore, the combined reproducibility rates for both product builds differ by no more than 0.4%, overall, for both best and worst case. The observed level of agreement between modes indicates that both product builds are associated with results that occur at a similar location on the MIC scale. The small difference in reproducibility rates provides evidence that AST result variability is nearly identical for both PB1 and PB2.
The best-case reproducibility was acceptable for all drugs evaluated for a representative class of Gramnegative, Gram-positive, Streptococcus, and Yeast drugs.
Study 3
The purpose of Study 3 was an Abbreviated Reproducibility Study was to assess the performance of the VITEK® DENSICHEK® Product Build 2 when end-user variability was introduced. A subset of the reproducibility data collected internally using VITEK® Product Build 2 was combined with data collected at two external sites.
VITEK® DENSICHEK® Product Build 2 met the performance criteria of >95% across all sites reproducibility with no observed exceptions.
Data analysis was then completed to compare reproducibility directly between Product Build 2 (PB2) and DENSICHEK Plus (Plus). Table 1 provides a summary of the dilution differences between modes from the two devices by auto dilution, manual dilution, and combined. Table 2 shows a comparison of reproducibility rates from the two devices. As with the original analysis comparing Product Build 1 and Product Build 2, organism/antimicrobial combinations having a mode that was off-scale were removed from the analysis. Again, the rationale being reproducibility or variation between results can be measured more accurately using on-scale organisms.
7
| Dilution
Method | Dilution Difference | | | | | Essential
Agreement |
|--------------------|---------------------|-------------|--------------|-----------|-----------|------------------------|
| | ≤ -2 | -1 | 0 | +1 | ≥ +2 | |
| Auto | 2
1.1% | 23
12.1% | 160
84.2% | 5
2.6% | 0
0.0% | 188/190
98.9% |
| Manual | 2
1.1% | 20
10.5% | 165
86.8% | 3
1.6% | 0
0.0% | 188/190
98.9% |
| Combined | 4
1.1% | 43
11.3% | 325
85.5% | 8
2.1% | 0
0.0% | 376/380
98.9% |
Table 1: Distribution of Dilution Differences Between Modes from Reproducibility Testing (PB2 – Plus)
| Table 2: Overall Reproducibility Rate Comparison | |||||
|---|---|---|---|---|---|
| -------------------------------------------------- | -- | -- | -- | -- | -- |
| Dilution
| Method | Best Case | Worst Case | ||||
|---|---|---|---|---|---|---|
| Plus | PB2 | Difference | Plus | PB2 | Difference | |
| Auto | 99.4% | 99.7% | -0.3% | 98.6% | 98.8% | -0.2% |
| Manual | 99.2% | 99.1% | 0.1% | 98.2% | 98.2% | 0.0% |
| Combined | 99.3% | 99.4% | -0.1% | 98.4% | 98.5% | -0.1% |
From the comparison of modes, the agreement rate within ± 1 doubling dilution is nearly 99% indicating a high level of correlation between results from the two devices. For the comparison of reproducibility rates, the differences are small for both dilution methods.