(210 days)
Predicate Device(s) K/DEN: K191766
No
The description focuses on a microdilution technique and automated monitoring of bacterial growth, with no mention of AI or ML algorithms for interpretation or analysis.
No
This device is an in vitro diagnostic (IVD) test, specifically designed for antimicrobial susceptibility testing in clinical laboratories. It determines the susceptibility of microorganisms to antimicrobial agents, which is a diagnostic function, not a therapeutic one. Therapeutic devices are used to treat or prevent disease, while this device aids in the selection of appropriate treatment by providing susceptibility information.
Yes.
The device is intended for "antimicrobial susceptibility testing" to "determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents," which are diagnostic functions. It aids in the determination of "in vitro susceptibility" to antimicrobial agents.
No
The device description clearly outlines a physical card with wells containing premeasured portions of antibiotics and culture media, which is then processed by a VITEK® 2 System (a hardware instrument). This is not a software-only device.
Based on the provided text, the device is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is designed for "in vitro susceptibility testing" 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 outside of a living organism, using a sample (bacterial isolate) and reagents (antibiotics combined with culture media) in a laboratory setting. This aligns with the definition of an in vitro diagnostic test.
- Clinical Laboratories: The "Intended User / Care Setting" is listed as "clinical laboratories," which are the typical environments where IVD tests are performed.
- Performance Studies: The description of performance studies involves testing clinical isolates in a laboratory setting and comparing the results to a reference method, which is characteristic of the validation process for IVD devices.
Therefore, all the provided information points to the VITEK® 2 AST-Gram Negative Fosfomycin being an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Gram Negative Fosfomycin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Fosfomyoin 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:
Escherichia coli
The VITEK® 2 Gram-Negative 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 sigmificant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.
Product codes
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-GN Fosfomycin (≤4 - ≥256 ug/mL) has the following concentrations in the card: 2, 8, 16 and 64 ug/mL (equivalent standard method concentration by efficacy in ug/mL).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories
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
The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GN 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-GN Fosfomycin by comparing its performance with the CLSI agar dilution reference method incubated at 16-24 hrs. The data is representative of performance on both the VITEK® 2 Compact instrument platforms.
Summary of Performance Studies
Study Type: External evaluation comparing performance with CLSI agar dilution reference method.
Sample Size: Performance for Enterobacter ales (E. coli) (380 samples total)
Key Results: The VITEK® 2 AST-GN Fosfomycin demonstrated acceptable performance. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics
%EA (Essential Agreement): (377/380) 99.2
VME (Very Major Error): N/A
ME (Major Error): N/A
mE (Minor Error): N/A
%CA (Category Agreement): (379/380) 99.7
VME (Very Major Error): (0/14) 0.0
ME (Major Error): (0/365) 0.0
mE (Minor Error): (1/380) 0.3
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
March 9, 2023
bioMerieux SA, Inc. Craig Buehler Sr. Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042
Re: K222430
Trade/Device Name: VITEK 2 AST-Gram Negative Fosfomycin (≤4 - ≥256 µg/mL), VITEK 2 AST-GN Fosfomycin (≤4 - ≥256 µg/mL), VITEK 2 AST-GN Fosfomycin 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 10, 2022 Received: August 11, 2022
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 (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
1
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 803) 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 (OS) 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) Branch 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
2
Indications for Use
510(k) Number (if known) K222430
Device Name VITEK® 2 AST-GN Fosfomycin (256 ug/mL)
Indications for Use (Describe)
VITEK® 2 AST-Gram Negative Fosfomycin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Fosfomyoin 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:
Escherichia coli
The VITEK® 2 Gram-Negative 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 sigmificant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.
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 a blue top half and a gradient bottom half that transitions from yellow to green. The word "BIOMÉRIEUX" is written in white, sans-serif font across the center of the blue portion of the circle.
510(k) SUMMARY
B.
C.
VITEK® 2 AST-Gram Negative Fosfomycin (≤4 - ≥256 µg/mL)
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Craig Buehler |
| Senior Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8358 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | August 9, 2022 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Gram Negative Fosfomycin (≤4 - ≥256 µg/mL) |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code: LON, LTW, LTT | |
| Common Name: | VITEK® 2 AST-GN Fosfomycin (≤4 - ≥256 µg/mL) |
| Predicate Device: | VITEK® 2 AST-GN Eravacycline (≤ 0.12 - ≥ 4 µg/ |
| mL) (K191766) |
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).
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
4
Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue semi-circle at the top and a yellow-green gradient semi-circle at the bottom. The word "BIOMÉRIEUX" is written in white letters in the blue semi-circle.
VITEK® 2 AST-GN Fosfomycin Traditional 510(k) Submission
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-GN Fosfomycin (≤4 - ≥256 ug/mL) has the following concentrations in the card: 2, 8, 16 and 64 ug/mL (equivalent standard method concentration by efficacy in ug/mL).
E. Substantial Equivalence Information:
The similarities and differences of the VITEK® 2 AST-GN Fosfomycin (≤4 - ≥256 µg/mL) when compared to the predicate device, VITEK® 2 AST-GN Eravacycline (≤ 0.12 ->24 ug/mL), are described in the Table 1 below.
| Item | Device:
VITEK® 2 AST-Gram Negative
Fosfomycin
( $\leq$ 4 - $\geq$ 256 µg/mL) | Predicate:
VITEK® 2 AST-GN
Eravacycline
( $\leq$ 0.12 - $\geq$ 4 µg/mL)
(K191766) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | VITEK® 2 AST-Gram Negative
Fosfomycin is designed for
antimicrobial susceptibility testing of
Gram negative 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 Negative Fosfomycin is
a quantitative test.
The VITEK® 2 Gram-Negative
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
negative bacilli to antimicrobial | VITEK® 2 AST-Gram Negative
Eravacycline is designed for
antimicrobial susceptibility testing
of Gram negative 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
Negative Eravacycline is a
quantitative test.
The VITEK® 2 Gram-Negative
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 |
| Item | Device:
VITEK® 2 AST-Gram Negative
Fosfomycin
( $=256$ µg/mL) | Predicate:
VITEK® 2 AST-GN
Eravacycline
( $ 4$ µg/mL)
(K191766) |
| Similarities | | |
| | agents when used as instructed. | Gram negative bacilli to
antimicrobial agents when used as
instructed. |
| Test Methodology | Automated quantitative
antimicrobial susceptibility test for
use with the VITEK® 2 and VITEK®
2 Compact Systems to determine the
in vitro susceptibility of
microorganisms | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | Gram Negative (AST-GN)
Susceptibility Card | Same |
| Instrument | VITEK® 2 and VITEK® 2 Compact
Systems | Same |
| Differences | | |
| Antimicrobial
Agent | Fosfomycin | Eravacycline |
| Concentrations | 2, 8, 16, 64 | 0.25, 1, 2, 4 |
| Indications for use | Fosfomycin has been shown to be
active against most strains of the
microorganisms listed below,
according to the FDA label for this
antimicrobial. | Eravacycline 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:
Escherichia coli | Active in vitro and in clinical
infections:
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
In vitro data are available, but
clinical significance is unknown:
Citrobacter koseri
Klebsiella (Enterobacter)
aerogenes |
Table 1: Substantial Equivalence
5
Image /page/5/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle divided into two halves. The top half is blue and contains the word "BIOMÉRIEUX" in white sans-serif font. The bottom half is yellow and green.
VITEK® 2 AST-GN Fosfomycin Traditional 510(k) Submission
6
Image /page/6/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle with the top half in dark blue and the bottom half in a gradient from yellow to green. The company name, "BIOMÉRIEUX", is written in white, sans-serif font across the center of the blue portion of the circle.
F. Intended Use:
VITEK® 2 AST-Gram Negative Fosfomycin is designed for antimicrobial susceptibility testing of Gram negative 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 Negative Fosfomycin in 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:
Escherichia coli
The VITEK® 2 Gram-Negative 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-negative bacilli to antimicrobial agents when used as instructed.
G. Performance Overview and Conclusion:
VITEK® 2 AST-GN 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-GN 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-GN Fosfomycin by comparing its performance with the CLSI agar dilution reference method incubated at 16-24 hrs. The data is representative of performance on both the VITEK® 2 Compact instrument platforms.
7
Image /page/7/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle with a blue upper half and a yellow-green lower half. The company name, "BIOMÉRIEUX", is written in white, sans-serif font in the center of the blue portion of the circle.
VITEK® 2 AST-GN Fosfomycin Traditional 510(k) Submission
The VITEK® 2 AST-GN Fosfomycin demonstrated acceptable performance as presented in Table 2 below:
| %EA | VME | ME | mE | %CA | VME | ME | mE | |
|---|---|---|---|---|---|---|---|---|
| Performance | ||||||||
| for | ||||||||
| Enterobacter | ||||||||
| ales (E. coli) | (377/380) | |||||||
| 99.2 | N/A | N/A | N/A | (379/380) | ||||
| 99.7 | (0/14) | |||||||
| 0.0 | (0/365) | |||||||
| 0.0 | (1/380) | |||||||
| 0.3 |
Table 2: VITEK® 2 AST-GN Fosfomycin Performance
Reproducibility and Quality Control demonstrated acceptable results.
H. References:
- MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic 1. Sensitivity Testing in the Clinical laboratory, Journal of Laboratory Clinical Medicine, 72:685-687, 1968.
- Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. Current Techniques for 2. Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL, 1974.
- Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, 3. Philadelphia, PA, 1976.