The VITEK® COMPACT PRO is intended for the automated quantitative and/or qualitative antimicrobial susceptibility testing of isolated colonies for most clinically significant aerobic Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., and yeast.

The VITEK® COMPACT PRO is also intended for the automated identification of most clinically significant anaerobic organisms and Corynebacterium species, fermenting and nonfermenting Gram-negative bacilli, Gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.

Device Description

The VITEK® COMPACT PRO instrument is an automated instrument designed for use in low-to medium-range applications in both Clinical and Industry laboratories. The instrument performs sample well filling, incubation, and optical readings. The VITEK® COMPACT PRO instrument is a two-step automated instrument for:

Hydrating reagents with sample inoculum
Pre-processing cards, incubating cards, and continuous reading for growth

The VITEK® 2 Systems Software receives the instrument optical readings and performs analysis. The instrument then ejects the completed reagent card into the waste area for disposal.

The system includes a VITEK® COMPACT PRO instrument with an internal computer, monitor, keyboard, mouse, handheld barcode scanner, and USB hub. The software provided with the internal computer includes analysis and limited data management programs. A bidirectional computer interface (BCI) may transfer results automatically to the user's laboratory information system (LIS).

A Quality Control System is available to track the quality control results of the test cards. The Advanced Expert System™ (Clinical Use) is available to provide online, systematic validation of results and interpretation of resistant phenotypes found during susceptibility testing.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the VITEK® COMPACT PRO, and its performance evaluation. However, it does not explicitly define "acceptance criteria" in a table format with specific numerical targets. Instead, it details the results of various performance tests as evidence that the device meets acceptable standards, primarily by demonstrating substantial equivalence to a predicate device.

Here's an interpretation of the acceptance criteria and study that can be extracted from the provided information:

Interpretation of Acceptance Criteria and Study Design:

The VITEK® COMPACT PRO is an automated antimicrobial susceptibility testing system. The core of its acceptance criteria and the study proving it meets these criteria relies on demonstrating substantial equivalence to a previously cleared VITEK® 2 System (N50510 Supplement S082). This means the new device must perform comparably to the predicate device across various metrics.

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance:

Since explicit acceptance criteria are not tabulated with thresholds, they are inferred from the reported performance, with the implicit criterion being "comparable to or better than the predicate device."

Performance Metric	Inferred Acceptance Criterion (vs. Predicate VITEK® 2)	Reported Device Performance (VITEK® COMPACT PRO)
Quality Control (QC)	Acceptable QC results within established ranges	QC passing >99% for each of the AST card classes tested (GN, GP, YS, ST) for 39 antimicrobial agents and 13 QC organisms.
Reproducibility	>95% Reproducibility (within 1 doubling dilution)	>97% reproducibility in the best case and >95% reproducibility in the worst case for all VITEK® 2 AST test cards/antimicrobials.
Clinical Performance (Accuracy)	High Essential Agreement (EA) with predicate	AST GN cards: 98.8% EA
(Essential Agreement - EA)	High Categorical Agreement (CA) with predicate	AST GP cards: 99.5% EA
Clinical Performance (Accuracy)		AST ST cards: 98.5% EA
(Categorical Agreement - CA)		AST YS cards: 100% EA
		AST GN cards: 97.3% CA
		AST GP cards: 97.4% CA
		AST ST cards: 98.7% CA
		AST YS cards: 100% CA
Usability/Safety (Human Factors)	Safe and effective for intended users/uses	Overall favorable with respect to usability. Minor usability errors mostly due to workflow changes and risk of ignoring warnings, but with appropriate mitigations, found safe and effective.
System Verification (Technical)	Successful completion and passing of requirements	Successfully completed for instrument, software/firmware interfaces (VITEK® COMPACT PRO Instrument, VITEK® firmware, VITEK® Systems 10.0 software, VITEK® COMPACT PRO User Interface, VITEK Systems Communications protocols).

2. Sample Sizes Used for the Test Set and Data Provenance:

QC Testing: Each of the 13 quality control organisms was tested at least twenty times. This testing was conducted at "at least three of the clinical evaluation trial sites."
Reproducibility: Isolates were tested in triplicate for three trial sites. Individual test sets were selected for each antimicrobial, with each set including a minimum of 10 strains (at least 2 with on-scale results).
Clinical Performance Evaluation: "Representative, clinically relevant strains" were tested. Each strain was tested one time with both the VITEK® COMPACT PRO and the VITEK® 2.
Data Provenance: The document states testing was done at "at least three of the clinical evaluation trial sites" for QC and "three trial sites" for reproducibility. The country of origin for these sites is not specified, but bioMérieux Inc. is located in Hazelwood, Missouri, USA, implying the studies were likely conducted in the US. The studies appear to be prospective as they involve new testing of isolates for performance evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not explicitly stated in the provided text. The ground truth for the clinical performance evaluation was established by comparing the VITEK® COMPACT PRO's results against the VITEK® 2 System's results (N50510 Supplement S082), which implicitly serves as the "expert consensus" or "reference method" in this context. The document does not describe a separate human expert panel for adjudication or ground truth establishment the way it might for an AI imaging device.

4. Adjudication Method for the Test Set:

Not applicable in the traditional sense of human expert adjudication. The comparison was directly between the new device (VITEK® COMPACT PRO) and the predicate device (VITEK® 2 System) for MICs and interpretations (S/SDD/I/R). There's no mention of a 2+1 or 3+1 human expert adjudication process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC study was not done. This device is an automated in vitro diagnostic instrument, not an AI-assisted imaging device for human interpretation. The comparison is machine-to-machine (new instrument vs. predicate instrument).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the primary performance evaluation was a standalone "algorithm only" (instrument only) performance comparison. The VITEK® COMPACT PRO (device under test) generated MICs and interpretations, and these were directly compared to those generated by the predicate VITEK® 2 System. Human "in-the-loop" performance is not relevant for the core function of this automated susceptibility system in the context of its performance study.

7. The type of ground truth used:

The ground truth for the clinical performance evaluation was the MIC results and categorical interpretations (S/SDD/I/R) obtained from the legally marketed predicate device, the VITEK® 2 System (N50510 Supplement S082). This serves as the reference method against which the new device's performance is measured.

8. The Sample Size for the Training Set:

The document does not discuss a separate "training set" in the context of device development or performance evaluation. This is not an AI/ML device where a distinct training dataset is typically used. The development process likely involved internal verification and validation, but the reported studies (QC, Reproducibility, Clinical Performance) are essentially testing/validation datasets.

9. How the ground truth for the training set was established:

Not applicable, as no explicit training set for an AI/ML algorithm is described.

Summary

{0}------------------------------------------------

March 14, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

bioMerieux Inc. Craig Buehler Sr. Regulatory Affairs Specialist - Microbiology 595 Anglum Rd. Hazelwood, Missouri 63042

Re: K234012

Trade/Device Name: Vitek Compact Pro 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: December 19, 2023 Received: December 19, 2023

Dear Craig Buehler:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).

{2}------------------------------------------------

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 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K234012

Device Name VITEK® COMPACT PRO

Indications for Use (Describe)

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."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a yellow-green bottom half. The word "BIOMÉRIEUX" is written in white letters in the blue portion of the circle.

510(k) SUMMARY

VITEK® COMPACT PRO

510(k) Submission Information:

Submitter's Name:	bioMerieux, Inc.
Manufacturer Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Craig BuehlerSr. Regulatory Affairs Specialist - Microbiology
Phone Number:	314 -731-8358
Fax Number:	314-731-8689
Date of Preparation:	March 5, 2025
Device Name:
Formal/Trade Name:	VITEK® COMPACT PRO
Regulation:	21 CFR 866.1645
Classification Name:	System, Test, Automated, Antimicrobial Susceptibility,Short Incubation
Common Name:	VITEK® COMPACT PRO
Predicate Device:	VITEK® 2 SYSTEM (PMA Number N50510 SupplementNumber S082)

D. 510(k) Summary:

The VITEK® COMPACT PRO is intended for laboratory use by professional users who are trained in microbiology and good laboratory practices.

This 510(k) submission introduces the VITEK® COMPACT PRO. The VITEK® COMPACT PRO instrument is an automated instrument designed for use in low-to medium-range applications in both Clinical and Industry laboratories. The instrument performs sample well filling, incubation, and optical readings. The VITEK® COMPACT PRO instrument is a two-step automated instrument for:

Hydrating reagents with sample inoculum
· Pre-processing cards, incubating cards, and continuous reading for growth

The VITEK® 2 Systems Software receives the instrument optical readings and performs analysis. The instrument then ejects the completed reagent card into the waste area for disposal.

10.4 - 1

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle on top of a green and yellow semi-circle. The word "BIOMÉRIEUX" is written in white letters inside the blue circle.

Intended Use:

The VITEK® COMPACT PRO is also intended for the automated identification of most clinically significant anaerobic organisms and Corynebacterium species, fermenting and nonfermenting Gram-negative bacilli. Gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.

Function	Device:VITEK® COMPACT PRO	Predicate:VITEK 2 SYSTEM(N50510 SupplementS082)
Intended Use	See Above	Same
Reagents	VITEK® 2 AST 64-well cards and VITEK® 2 ID 64-wellcards	Same
Type of Sample	Isolated colony from appropriate growth media	Same
Test set up	VITEK® FLEXPREP	Smart Carrier Stationor VITEK FLEXPREP
Card capacity	15 cards with licenses to expand to 30 and 60 cards	60 for VITEK 2 and120 for VITEK 2 XL
Cassette	10 cards/cassette	15 cards/cassette
Stages of Operation	Sample Preparation, Incubation and Optical Reading	Same
Reagent Processing
Card Inoculum	Prepared with an approved VITEK® inoculationpreparation device	Same
Filling Process	Vacuum Fill Process	Same
Sealer Process fortest cards	Automated, heat seal	Same
AST dilutionpreparation	Manual	Manual and Auto
Incubation and Optical Reading
Reader Optic forAST Cards	660 nm optics	Same
Reader Optic for IDCards	(428/568/680) nm optics, depending on the card'swell map	Same

Comparison Table:

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a green bottom half. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle.

Function	Device:VITEK® COMPACT PRO	Predicate:VITEK 2 SYSTEM(N50510 SupplementS082)
Control mechanism	Microprocessor-controlled electromechanical system	Same
Optical calibration	Self-calibrating	Same
Well ReadingFrequency	Every 15 minutes	Same
OpticalMeasurementAlgorithm	15 steps per well, taking three readings per step	Same
Incubation	Automated, 35.5°C +/- 1°C	Same
Card location duringincubation	Carousel	Same
Waste	Automated removal of ejected test cards to wastecontainer	Same
Analysis Interfaces
Analysis/Algorithms	VITEK 2 System Software algorithms used foranalysis	Same
AST PhenotypicAnalysis	Advanced Expert System (AES)	Same
Average Time toResult	AST: 8-12 H depending on the bugs/drugs	Same
LIS communication	Bidirectional Computer Interface (BCI)	Same

Summary of System. Biological and Clinical Performance:

The verification and validation testing of the VITEK® COMPACT PRO included biological performance testing, as well as, instrument/software testing.

Verification testing was completed on Beta and Pilot units, which are representative & equivalent to the final instrument design & manufacturing specifications. Results of the VITEK®COMPACT PRO system verification tests (i.e. for instrument, and software/firmware interfaces) were successfully completed and results passed in comparison with the documented requirements. The VITEK®COMPACT PRO verification testing included the VITEK®COMPACT PRO Instrument, the VITEK® firmware, the VITEK® Systems 10.0 software, the VITEK® COMPACT PRO User Interface, and the VITEK Systems Communications protocols, However, knowledge task questions revealed the maiority of participants had a good understanding of the VITEK® COMPACT PRO System and the potential risks. The outcome of the testing determined that VITEK® COMPACT PRO has been found to be safe and effective for the intended users, uses, and use environments.

Human Factor Usability was also included as part of the VITEK® COMPACT PRO testing. The overall, session results were favorable with respect to usability. Within the use scenarios, the most common cause of minor usability errors was in the change of workflow (as compared to the VITEK® 2 Systems), and risk of users ignoring warnings in the card processing steps. With appropriate mitigations, the VITEK® COMPACT PRO instrument was found to be safe and effective for the intended users, uses, and use environments.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle on top of a yellow and green circle. The word "BIOMÉRIEUX" is written in white letters inside the blue circle.

Prior to the clinical performance evaluation, verification testing included a performance evaluation, which utilized all the VITEK® 2 Antimicrobial Susceptibility Testing - i.e. GN, GP, YS, and ST test card classes.

Quality Control (QC) Testing

The quality control testing evaluated the performance of the VITEK® COMPACT PRO instrument as compared to the established package insert quality control ranges for thirty-nine antimicrobial agents. covering all the VITEK® 2 Antimicrobial Susceptibility Testing card classes (i.e. GN. GP. YS, and ST test cards). Thirteen quality control organisms were tested. Each isolate was tested at least twenty times at least three of the clinical evaluation trial sites. Quality control isolates were tested with the VITEK® 2 60 using manual dilution mode and the VITEK® EVO Compact, using the same initial McFarland suspension. Testing demonstrated the VITEK® COMPACT PRO gave acceptable quality control results with QC passing >99% for each of the AST card classes tested.

Reproducibility

Reproducibility performance was evaluated by testing isolates in triplicate for three trial sites. Reproducibility test sets were selected based on the following criteria:

Separate test sets were selected for each antimicrobial. ●
. Each set included at least 10 strains.
Each set included at least 2 strains with on-scale results for each antimicrobial. .

The overall reproducibility rate was calculated as the percentage of the total number of results that were within one doubling dilution of the modal card result. If a mode could not be established, the median result was used. Results within ± one doubling dilution from the mode were used to calculate reproducibility performance. Analysis was performed for each drug/organism combination which revealed acceptable reproducibility. The VITEK® COMPACT PRO reproducibility testing demonstrated that all the VITEK® 2 AST test cards/antimicrobials showed a >97% reproducibility in the best case and a >95% reproducibilitv in the worst case.

Clinical Performance Evaluation

The accuracy of MICs obtained by the VITEK® COMPACT PRO was evaluated using representative, clinically relevant strains, tested on all the VITEK® 2 AST test class (i.e. AST GN, GP, ST, and YS). Each strain was grown on appropriate agar media for appropriate incubation times and the cultured isolates were tested one time with both the VITEK® 2 and the VITEK® COMPACT PRO, using the same initial McFarland suspension with each antibiotic panel.

The MICs obtained using the VITEK® COMPACT PRO were then compared to the MICs obtained using the VITEK® 2. MICs obtained using the VITEK® COMPACT PRO demonstrated very high agreement in essential agreement (EA) and categorical agreement (CA) with the MICs obtained using the VITEK® 2. Essential Agreement (EA) was defined as MIC results obtained from the VITEK COMPACT PRO that were within one doubling dilution of the MIC results obtained from the VITEK 2. Category Agreement (CA) was defined as MIC interpretations (S/SDD/I/R) that were the same between the VITEK COMPACT PRO and VITEK 2. Analysis was performed for each drug/organism combination which revealed acceptable EA and CA. The clinical performance evaluation demonstrated that in comparison with the accuracy for the VITEK® 2 AST GN cards was 98.8% EA and 97.3% CA. the VITEK® 2 AST GP cards was 99.5% EA and 97.4% CA, the VITEK®2 AST ST cards was 98.5% EA and 98.7% CA, and the VITEK®2 AST YS cards was 100% on both EA and CA.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle that is split into two colors. The top half of the circle is blue, and the bottom half is yellow and green. The word "BIOMÉRIEUX" is written in white letters in the blue portion of the circle.

Conclusion:

Based on the clinical performance data presented to support substantial equivalence decision, the VITEK® COMPACT PRO is substantially equivalent to the VITEK® 2 System (N50510, Supp 82). The VITEK® COMPACT PRO has the same intended use and the same technological characteristics as the VITEK® 2 System. The clinical performance evaluation demonstrated that the VITEK® COMPACT PRO is as safe and effective as the predicate VITEK® 2 System. No new questions of safety and effectiveness were raised during the verification, and/or clinical performance evaluation.

Regulation Number and Section

§ 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.”