(81 days)
Not Found
No
The description focuses on the 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 to determine the susceptibility of bacteria to antimicrobial agents, aiding laboratories in selecting appropriate treatments rather than directly providing therapy.
Yes
The device is designed for "antimicrobial susceptibility testing" to determine the "in vitro susceptibility to antimicrobial agents" and provides "MIC value along with the interpretive category result," which are all diagnostic functions.
No
The device description clearly details a physical AST card with wells containing antibiotics and culture media, which is a hardware component. The system also involves automated or manual filling, sealing, and incubation, indicating a significant hardware element.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states the device is "designed for antimicrobial susceptibility testing of Gram Negative bacilli" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The phrase "in vitro" 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 "microdilution minimum inhibitory concentration (MIC) technique." This is characteristic of an in vitro test.
- Intended User / Care Setting: The device is intended for use in "clinical laboratories," which are the typical 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(s)" with a K number (K183415) indicates that this device has gone through a regulatory process, likely with the FDA, which is required for IVDs.
All these points strongly support the classification of this device as an In Vitro Diagnostic.
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 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: 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.
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 () 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
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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: External evaluation comparing device performance with CLSI broth microdilution reference method.
Sample Size: Not specified, but includes fresh and stock clinical isolates and challenge strains.
Key Results:
- Essential Agreement:
- Enterobacteriaceae: 95.3%
- P. aeruginosa: 96.2%
- Overall (Enterobacteriaceae and P. aeruginosa combined): 95.6%
- Category Agreement:
- Enterobacteriaceae: 98.9%
- P. aeruginosa: 95.5%
- Overall (Enterobacteriaceae and P. aeruginosa combined): 98.0%
- Reproducibility and Quality Control: Demonstrated acceptable results.
Key Metrics
Essential Agreement: 95.6%
Category Agreement: 98.0%
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 13, 2020
BioMerieux, Inc. Jolyn Tenllado Regulatory Affairs Expert 595 Anglum Road Hazelwood, Missouri 63042
Re: K193572
Trade/Device Name: VITEK 2 AST-Gram Negative Imipenem/Relebactam (B. 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 |
| C. Predicate Device: | VITEK® 2 AST-GN Imipenem (K183415) |
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 () 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
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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 green and yellow bottom half. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle.
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 (K183415), are described in the following table.
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Image /page/4/Picture/0 description: The image shows the logo for bioMerieux. The logo is a circle that is split into two halves. The top half is blue and contains the word "BIOMERIEUX" in white letters. The bottom half of the circle is yellow and green.
| Item | Device:
VITEK® 2 AST-GN
Imipenem/Relebactam | Predicate:
VITEK® 2 AST-GN Imipenem
(K183415) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 of the
microorganisms listed below, according
to the FDA label for this antimicrobial.
Active in vitro and in clinical infections:
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 | VITEK® 2 AST-Gram Negative
Imipenem 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 is a
quantitative test. Imipenem 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 spp.
Citrobacter spp.
Enterobacter spp. (excluding E.
aerogenes)
Escherichia coli
Klebsiella spp.
Pseudomonas aeruginosa
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. |
| Item | Device:
VITEK® 2 AST-GN
Imipenem/Relebactam | Predicate:
VITEK® 2 AST-GN Imipenem
(K183415) |
| Similarities | | |
| Intended Use
(Cont.) | 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 Gram negative bacilli | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | VITEK® 2 Gram Negative Susceptibility
Test Card | Same |
| Instrument | VITEK® 2 and VITEK® 2
Compact Systems | Same |
| Analysis
Algorithms | Growth Pattern Analysis | Same |
| Differences | | |
| Antimicrobial
Agent | Imipenem/Relebactam | Imipenem |
| Antimicrobial
Concentration | 0.25/4, 1/4, 4/4, 16/4 | 0.5, 2, 8, 16 |
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F. Intended Use:
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Image /page/6/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle on top and a green circle on the bottom. The word "BIOMÉRIEUX" is written in white letters in the center of the blue circle.
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: 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.
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 (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
7
hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
VITEK® 2 AST-GN Imipenem/Relebactam demonstrated acceptable performance of 95.3% Essential Agreement and 98.9% Category Agreement for Enterobacteriaceae and 96.2% Essential Agreement and 95.5% Category Agreement for P. aeruginosa with the reference method. Overall performance for Enterobacteriaceae and P. aeruginosa combined was 95.6% Essential Agreement and 98.0% Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
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.