Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a microdilution technique for antimicrobial susceptibility testing and does not mention any AI or ML components.

Therapeutic

No.
The device is described as an in vitro diagnostic test for determining the susceptibility of microorganisms to antimicrobial agents, providing a "laboratory aid" in determining in vitro susceptibility. It does not directly treat or diagnose a disease in a living patient, which is characteristic of a therapeutic device.

Diagnostic

Yes.

The device is designed for antimicrobial susceptibility testing of Gram positive microorganisms and is explicitly stated to be a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," which directly contributes to the diagnosis and treatment of infections.

SaMD (Software as a Medical Device)

No

The device description explicitly details a physical card with wells containing premeasured antibiotic and culture media, which is a hardware component. The system also involves automated or manual filling, sealing, and incubation, indicating a significant hardware element.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it is "designed for antimicrobial susceptibility testing of Gram positive microorganisms" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The term "in vitro" is a key indicator of an IVD.
Device Description: The description details a test performed on a sample (bacterial or yeast isolate) outside of the body, using a system that analyzes the interaction between the microorganism and antimicrobial agents in a controlled environment (the wells of the card). This is the core principle of in vitro testing.
Intended User / Care Setting: The intended user is "clinical laboratories," which are settings where in vitro diagnostic tests are typically performed.
Performance Studies: The performance studies compare the device's results to a "CLSI agar dilution reference method," which is a standard in vitro diagnostic technique for antimicrobial susceptibility testing. The metrics used (%EA, %CA, VME, ME, mE) are standard performance indicators for IVD susceptibility tests.

Therefore, all aspects of the provided information align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

VITEK® 2 AST-Gram Positive Fosfomycin is designed for antimicrobial susceptibility testing of Gram positive microorganisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Positive Fosfomycin is a quantitative test. Fosfomycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections: Enterococcus faecalis

The VITEK® 2 Gram-Positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-positive microorganisms to antimicrobial agents when used as instructed.

Product codes (comma separated list FDA assigned to the subject device)

LON, LTW, LTT

Device Description

The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh(1) and Gerlach(0). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3).

Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

VITEK® 2 AST-GP Fosfomycin (

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.”

Summary

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September 14, 2021

bioMérieux, Inc. Debra Broyles Sr. Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042

Re: K202396

Trade/Device Name: VITEK 2 AST-Gram Positive Fosfomycin (≤8 - ≥256 µg/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, LTW, LTT Dated: August 20, 2020 Received: August 21, 2020

Dear Debra Broyles:

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, 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)

Device Name

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)

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Image /page/3/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with two different 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.

510(k) SUMMARY

B.

C.

VITEK® 2 AST-Gram Positive Fosfomycin (≤8 - ≥256 µg/mL)

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum Road
Hazelwood, MO 63042
Contact Person:	Debra Broyles
Senior Regulatory Affairs Specialist
Phone Number:	314 -731-8805
Fax Number:	314-731-8689
Date of Preparation:	August 5, 2020
Device Name:
Formal/Trade Name:	VITEK® 2 AST-Gram Positive Fosfomycin (≤8 - ≥256
µg/mL)
Classification Name:	21 CFR 866.1645
Fully Automated Short-Term Incubation Cycle
Antimicrobial Susceptibility System
Product Code: LON
Common Name:	VITEK® 2 AST-GP Fosfomycin (≤8 - ≥256 µg/mL)
Predicate Device:	VITEK® 2 AST-GP Dalbavancin (≤0.015 – ≥1 µg/mL)
(K190616)

D. Device Description:

The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh(1) and Gerlach(0). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3).

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 green and yellow bottom half. The word "BIOMÉRIEUX" is written in white letters in the blue portion of the circle.

Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

VITEK® 2 AST-GP Fosfomycin (1 ug/mL). are described in the Table 1 below.

| Item | Device:
VITEK® 2 AST-GP
Fosfomycin
(≤8 - ≥256 µg/mL) | Predicate:
VITEK® 2 AST-GP
Dalbavancin
(≤ 0.015 – ≥ 1 µg/mL)
(K190616) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | VITEK® 2 AST-Gram Positive
Fosfomycin is designed for
antimicrobial susceptibility
testing of Gram positive
microorganisms and is intended
for use with the VITEK® 2 and
VITEK® 2 Compact Systems as
a laboratory aid in the
determination of in vitro
susceptibility to antimicrobial
agents. VITEK® 2 AST-Gram
Positive Fosfomycin is a
quantitative test. Fosfomycin | VITEK® 2 AST-Gram Positive
Dalbavancin is designed for
antimicrobial susceptibility
testing of Gram positive bacilli
and is intended for use with the
VITEK® 2 and VITEK® 2
Compact Systems as a
laboratory aid in the
determination of in vitro
susceptibility to antimicrobial
agents. VITEK® 2 AST-Gram
Positive Dalbavancin is a
quantitative test. Dalbavancin |
| Item | Device:
VITEK® 2 AST-GP
Fosfomycin
(≤8 - ≥256 µg/mL) | Predicate:
VITEK® 2 AST-GP
Dalbavancin
( ≤ 0.015 – ≥ 1 µg/mL)
(K190616) |
| | Similarities | |
| | has been shown to be active
against most strains of the
microorganisms listed below,
according to the FDA label for
this antimicrobial.
Active in vitro and in clinical
infections: | has been shown to be active
against most strains of the
microorganisms listed below,
according to the FDA label for
this antimicrobial.
Active both in vitro and in
clinical infections |
| | Enterococcus faecalis | Staphylococcus aureus
(including methicillin-resistant
isolates) |
| | The VITEK® 2 Gram-Positive
Susceptibility Card is intended
for use with the VITEK® 2
Systems in clinical laboratories
as an in vitro test to determine
the susceptibility of clinically
significant aerobic Gram
positive microorganisms to
antimicrobial agents when used
as instructed. | Enterococcus faecalis
(vancomycin-susceptible
isolates only)

Streptococcus agalactiae

Enterococcus faecalis
(vancomycin-susceptible
isolates only)

Streptococcus agalactiae |

Table 1・ Substantial Equivalence

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F. Intended Use:

VITEK® 2 AST-Gram Positive Fosfomycin is designed for antimicrobial susceptibility testing of Gram positive microorganisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Positive Fosfomycin is a quantitative test. Fosfomycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections:

Enterococcus faecalis

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Image /page/7/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with two horizontal sections. The top section is blue and contains the word "BIOMÉRIEUX" in white, sans-serif font. The bottom section is a gradient that transitions from yellow on the left to green on the right.

The VITEK® 2 Gram-Positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-positive microorganisms to antimicrobial agents when used as instructed.

G. Performance Overview and Conclusion:

VITEK® 2 AST-GP Fosfomycin demonstrated substantially equivalent performance when compared with the CLSI agar dilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009).

The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GP Fosfomycin. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GP Fosfomycin by comparing its performance with the CLSI agar dilution reference method incubated at 16-20 hrs. The data is representative of performance on both the VITEK® 2 Compact instrument platforms.

The VITEK® 2 AST-GP Fosfomycin demonstrated acceptable performance as presented in Table 2 below:

| Overall
Performance
(with the
reference

method)	%EA	VME	ME	mE
	(388/399)
97.2	N/A	N/A	N/A	(386/399)
96.7	(0/1)
0.0	(0/385)
0.0	(13/399)
3.3

Table 2: VITEK® 2 AST-GP Fosfomycin Performance

Reproducibility and Quality Control demonstrated acceptable results.

H. References:

1. MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic Sensitivity Testing in the Clinical laboratory, Journal of Laboratory Clinical Medicine, 72:685-687, 1968.
1. Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. Current Techniques for Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL, 1974.

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1. Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, Philadelphia, PA, 1976.