(59 days)
Not Found
No
The description focuses on a microdilution technique and automated monitoring of bacterial growth, with no mention of AI or ML algorithms for analysis or interpretation.
No.
This device is an in vitro diagnostic (IVD) device used in laboratories to determine the susceptibility of microorganisms to antimicrobial agents. It does not directly treat or diagnose a disease in a patient, which are functions of a therapeutic device.
Yes.
The device is designed for antimicrobial susceptibility testing, which determines the in vitro susceptibility of Gram-negative bacilli to antimicrobial agents, aiding in the determination of MIC values and interpretive category results for infection treatment.
No
The device description clearly states that the VITEK® 2 AST card contains physical wells with premeasured portions of antibiotic combined with culture media, which are then processed by the VITEK® 2 Systems (hardware). This is not a software-only device.
Yes, 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 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." The phrase "in vitro susceptibility" is a key indicator of an IVD.
- Device Description: The description details a test performed on a sample (bacterial isolate) outside of the body, using a specific card containing reagents (antibiotics and culture media) to determine a characteristic of the sample (susceptibility to antimicrobial agents). This aligns with the definition of an in vitro diagnostic test.
- Clinical Laboratories: The intended user is specified as "clinical laboratories," which are common settings for performing IVD tests.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard method for in vitro susceptibility testing.
- Predicate Device: The mention of a predicate device (K193572; VITEK® 2 AST-GN Imipenem/Relebactam) suggests that this device is being submitted for regulatory clearance as an IVD, likely through the 510(k) pathway, which is for devices substantially equivalent to a legally marketed predicate device.
All these factors strongly indicate that the VITEK® 2 AST-Gram Negative Imipenem/Relebactam is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Gram Negative Imipenem/Relebactam 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 Imipenem/Relebactam is a quantitative test. Imipenem/Relebactam 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: Acinetobacter calcoaceticus-baumannii complex Klebsiella (Enterobacter) aerogenes Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Citrobacter freundii Klebsiella oxytoca
In vitro data are available, but clinical significance is unknown: Citrobacter koseri Enterobacter asburiae
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 bacili 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 (2). 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 Imipenem/Relebactam has the following concentrations in the card: 0.25/4, 1/4, 4/4 and 16/4 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
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 Imipenem/Relebactam by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-GN Imipenem/Relebactam demonstrated substantially equivalent performance when compared with the CLSI broth microdilution 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 (Traditional 510[k]) presents data in support of VITEK® 2 AST- GN Imipenem/Relebactam. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: 98.2%
Categorical Agreement: 98.2%
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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 14, 2021
bioMérieux, Inc Esther Hernandez Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K211136
Trade/Device Name: VITEK 2 AST-Gram Negative Imipenem/Relebactam (16/4 ug/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: April 15, 2021 Received: April 16, 2021
Dear Esther Hernandez:
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
1
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 (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
VITEK® 2 AST-Gram Negative Imipenem/Relebactam (16/4 ug/mL)
Indications for Use (Describe)
VITEK® 2 AST-Gram Negative Imipenem/Relebactam 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 Imipenem/Relebactam is a quantitative test. Imipenem/Relebactam 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: Acinetobacter calcoaceticus-baumannii complex Klebsiella (Enterobacter) aerogenes Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Citrobacter freundii Klebsiella oxytoca
In vitro data are available, but clinical significance is unknown: Citrobacter koseri Enterobacter asburiae
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 bacili 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 consists of a blue circle on top of a green circle. The word "BIOMÉRIEUX" is written in white letters inside the blue circle. The green circle has a gradient, with the top being a lighter shade of green and the bottom being a darker shade of green.
510(k) SUMMARY
B.
C.
VITEK® 2 AST-GN Imipenem/Relebactam
A. 510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Esther Hernandez |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8841 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | April 08, 2021 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST- Gram Negative |
| Imipenem/Relebactam (≤ 0.25/4 -> 16/4 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-GN Imipenem/Relebactam |
| Predicate Device: | VITEK® 2 AST-GN Imipenem/Relebactam |
| (K193572) |
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 (2). 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 that is split into two sections. The top section is a dark blue color and contains the company name "BIOMÉRIEUX" in white letters. The bottom section is a gradient of yellow and green.
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 Imipenem/Relebactam has the following concentrations in the card: 0.25/4, 1/4, 4/4 and 16/4 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 Imipenem/Relebactam when compared to the predicate device, VITEK 2 AST-GN Imipenem/Relebactam (K193572), are described in the following table. The only difference between both devices is the addition of an Indications for Use, Acinetobacter calcoaceticus-baumannii complex.
| Item | Device:
VITEK® 2 AST-GN
Imipenem/Relebactam | Predicate:
VITEK® 2 AST-GN
Imipenem/Relebactam
(K193572) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | VITEK® 2 AST-Gram Negative
Imipenem/Relebactam 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
Imipenem/Relebactam is a quantitative
test. Imipenem/Relebactam has been
shown to be active against most strains | VITEK® 2 AST-Gram Negative
Imipenem/Relebactam 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
Imipenem/Relebactam is a quantitative
test. Imipenem/Relebactam has been
shown to be active against most strains of |
| Item | Device:
VITEK® 2 AST-GN
Imipenem/Relebactam | Predicate:
VITEK® 2 AST-GN
Imipenem/Relebactam
(K193572) |
| | Similarities | |
| | of the microorganisms listed below, | |
| | according to the FDA label for this | |
| | antimicrobial. | |
| | | |
| | Active in vitro and in clinical infections: | |
| | Acinetobacter calcoaceticus-baumannii
complex | |
| | Klebsiella (Enterobacter) aerogenes
Enterobacter cloacae
Escherichia coli
Klebsiella pneumoniae
Pseudomonas aeruginosa
Citrobacter freundii
Klebsiella oxytoca | |
| | In vitro data are available, but clinical | |
| | significance is unknown: | |
| | Citrobacter koseri
Enterobacter asburiae | |
| | | |
| | 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. | |
| 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 |
| Antimicrobial Agent | Imipenem/Relebactam | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | Gram-negative (AST-GN)
Susceptibility Card | Same |
| Analysis Algorithms | Growth Pattern Analysis | Same |
| Instrument | VITEK®2 and VITEK®2 Compact | Same |
| Item | Device:
VITEK® 2 AST-GN
Imipenem/Relebactam | Predicate:
VITEK® 2 AST-GN
Imipenem/Relebactam
(K193572) |
| Similarities | | |
| | Systems | |
| Concentrations | 0.25/4, 1/4, 4/4, 16/4 | Same |
5
Image /page/5/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a yellow-green gradient bottom half. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle.
6
Image /page/6/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 dark blue and has the word "BIOMÉRIEUX" in white letters. The bottom half of the circle is yellow and green.
F. Intended Use:
VITEK® 2 AST-Gram Negative Imipenem/Relebactam 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 Imipenem/Relebactam is a quantitative test. Imipenem/Relebactam 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: Acinetobacter calcoaceticus-baumannii complex Klebsiella (Enterobacter) aerogenes Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Citrobacter freundii Klebsiella oxytoca
In vitro data are available, but clinical significance is unknown:
Citrobacter koseri Enterobacter asburiae
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.
7
F. Performance Overview and Conclusion:
VITEK® 2 AST-GN Imipenem/Relebactam demonstrated substantially equivalent performance when compared with the CLSI broth microdilution 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 (Traditional 510[k]) presents data in support of VITEK® 2 AST- GN Imipenem/Relebactam. 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 Imipenem/Relebactam by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
The VITEK 2 AST-GN Imipenem/Relebactam demonstrated acceptable performance of 98.2% Essential Agreement and 98.2% Categorical Agreement for the Acinetobacter calcoaceticus-baumannii complex compared with the reference method.
References:
-
- 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.
-
- 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.
-
- Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, Philadelphia, PA, 1976.