(385 days)
Not Found
No
The description focuses on a microdilution technique and monitoring growth over time, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is designed for in vitro antimicrobial susceptibility testing, providing information for laboratory use and not directly delivering therapy or treatment.
Yes
This device is designed for "antimicrobial susceptibility testing of Gram negative bacilli" and aids "in the determination of in vitro susceptibility to antimicrobial agents," which are diagnostic purposes for identifying appropriate treatments.
No
The device description explicitly details a physical 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 hardware system is integral to the device's function.
Yes, this device is 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 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." The phrase "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 "microdilution minimum inhibitory concentration (MIC) technique." This is characteristic of an in vitro test.
- Clinical Laboratories: The "Intended User / Care Setting" is "clinical laboratories," which are the typical settings for performing in vitro diagnostic tests.
- Performance Studies: The document describes performance studies comparing the device 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 (K191766) indicates that this device has gone through a regulatory process, likely with the FDA, for approval as a medical device, specifically an IVD. Predicate devices are used for comparison in the 510(k) submission process for IVDs.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Gram Negative Meropenem 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 Meropenem in is a quantitative test. Meropenem 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 Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
In vitro data are available, but clinical significance is unknown:
Citrobacter freundii Citrobacter koseri Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Morganella morganii Serratia marcescens
The VITEK® 2 Gram Negative Susceptibility Card Meropenem also reports susceptibility for the following additional organisms as listed on the FDA Susceptibility Test Interpretive Criteria website:
Acinetobacter spp.
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(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 cvcle, 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 Meropenem (≤0.25 - ≥16 µg/mL) has the following concentrations in the card: 0.5, 1. 2. 4 and 8 ug/mL (equivalent standard method concentration by efficacy in us/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 Meropenem by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs.
Summary of Performance Studies
Study Type: External evaluation
Sample Size: Overall Performance (1070)
Key Results:
Overall Performance (with the reference method):
%EA: (1016/1070) 95.0
%CA: (1016/1070) 95.0
VME: (0/346) 0.0
ME: (4/680) 0.6
mE: (50/1070) 4.7
Enterobacterales:
%EA: (537/569) 94.4
%CA: (552/569) 97.0
VME: (0/65) 0.0
ME: (4/491) 0.8
mE: (13/569) 2.3
P. aeruginosa:
%EA: (267/282) 94.7
%CA: (253/282) 89.7
VME: (0/121) 0.0
ME: (0/137) 0.0
mE: (29/282) 10.3
Acinetobacter spp.:
%EA: (212/219) 96.8
%CA: (211/219) 96.3
VME: (0/160) 0.0
ME: (0/52) 0.0
mE: (8/219) 3.7
Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics
%EA (Essential Agreement), %CA (Category Agreement), VME (Very Major Error), ME (Major Error), mE (Minor Error)
Predicate Device(s)
VITEK® 2 AST-GN Eravacycline (≤ 0.12 - ≥ 4 µg/mL) (K191766)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
July 9, 2021
bioMérieux, Inc. Debra Broyles Sr. Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042
Re: K201675
Trade/Device Name: VITEK 2 AST-Gram Negative Meropenem (≤ 0.25 - ≥ 16 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: June 18, 2020 Received: June 19, 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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510(k) SUMMARY
B.
C.
VITEK® 2 AST-Gram Negative Meropenem (≤0.25 - ≥16 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: | December 8, 2020 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Gram Negative Meropenem (≤0.25 - ≥16 |
| $µg/mL$ ) | |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code(s): LON, LTW, LTT | |
| Common Name: | VITEK® 2 AST-GN Meropenem (≤0.25 - ≥16 $µg/mL$ ) |
| 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).
4
Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue semi-circle on top and a yellow-green semi-circle on the bottom. The word "BIOMÉRIEUX" is written in white letters in the center of the blue semi-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 cvcle, 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 Meropenem (≤0.25 - ≥16 µg/mL) has the following concentrations in the card: 0.5, 1. 2. 4 and 8 ug/mL (equivalent standard method concentration by efficacy in us/mL).
E. Substantial Equivalence Information:
The similarities and differences of the VITEK® 2 AST-GN Meropenem (≤0.25 - ≥16 µg/mL) when compared to the predicate device, VITEK® 2 AST-GN Eravacycline ( ≤ 0.12 –> 4 ug/mL), are described in the Table 1 below.
| Item | Device:
VITEK® 2 AST-Gram
Negative Meropenem
( $\leq$ 0.25 - $\geq$ 16 µg/mL) | Predicate:
VITEK® 2 AST-GN
Eravacycline
( $\leq$ 0.12 - $\geq$ 4 µg/mL)
(K191766) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use | VITEK® 2 AST-Gram Negative
Meropenem 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 Meropenem
in is a quantitative test.
Meropenem has been shown to be
active against most strains of the
microorganisms listed below,
according to the FDA label for
this 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. Eravacycline has
been shown to be active against
most strains of the microorganisms
listed below, according to the FDA
label for this antimicrobial. |
| Item | Device:
VITEK® 2 AST-Gram
Negative Meropenem
( $≤0.25 - ≥16$ µg/mL) | Predicate:
VITEK® 2 AST-GN
Eravacycline
( $≤ 0.12 - ≥ 4$ µg/mL)
(K191766) |
| Similarities | | |
| | Active in vitro and in clinical infections:
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa
In vitro data are available, but clinical significance is unknown:
Citrobacter freundii
Citrobacter koseri
Enterobacter cloacae
Hafnia alvei
Klebsiella oxytoca
Morganella morganii
Serratia marcescens
The VITEK® 2 Gram Negative Susceptibility Card Meropenem also reports susceptibility for the following additional organisms as listed on the FDA Susceptibility Test Interpretive Criteria website:
Acinetobacter spp
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. | 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
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-Gram
Negative Meropenem
( $\leq$ 0.25 - $\geq$ 16 µg/mL) | Predicate:
VITEK® 2 AST-GN
Eravacycline
( $\leq$ 0.12 - $\geq$ 4 µg/mL)
(K191766) |
| Similarities | | |
| 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 | Meropenem | Eravacycline |
| Concentrations | 0.5, 2, 6, 12 | 0.25, 1, 2, 4 |
Table 1: Substantial Equivalence
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F. Intended Use:
VITEK® 2 AST-Gram Negative Meropenem 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 Meropenem in is a quantitative test. Meropenem 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 Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
In vitro data are available, but clinical significance is unknown:
Citrobacter freundii Citrobacter koseri
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Image /page/7/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 blue portion of the circle.
Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Morganella morganii Serratia marcescens
The VITEK® 2 Gram Negative Susceptibility Card Meropenem also reports susceptibility for the following additional organisms as listed on the FDA Susceptibility Test Interpretive Criteria website:
Acinetobacter spp.
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 Meropenem 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 Meropenem. 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 Meropenem by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
The VITEK® 2 AST-GN Meropenem demonstrated acceptable performance as presented in Table 2 below:
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| Table 2: VITEK® 2 AST-GN Meropenem Performance | ||||||||
|---|---|---|---|---|---|---|---|---|
| %EA | VME | ME | mE | %CA | VME | ME | mE | |
| Overall | ||||||||
| Performance (with | ||||||||
| the reference | ||||||||
| method) | (1016/1070) | |||||||
| 95.0 | N/A | N/A | N/A | (1016/1070) | ||||
| 95.0 | (0/346) | |||||||
| 0.0 | (4/680) | |||||||
| 0.6 | (50/1070) | |||||||
| 4.7 | ||||||||
| Enterobacterales | (537/569) | |||||||
| 94.4 | N/A | N/A | N/A | (552/569) | ||||
| 97.0 | (0/65) | |||||||
| 0.0 | (4/491) | |||||||
| 0.8 | (13/569) | |||||||
| 2.3 | ||||||||
| P. aeruginosa | (267/282) | |||||||
| 94.7 | N/A | N/A | N/A | (253/282) | ||||
| 89.7 | (0/121) | |||||||
| 0.0 | (0/137) | |||||||
| 0.0 | (29/282) | |||||||
| 10.3 | ||||||||
| Acinetobacter spp. | (212/219) | |||||||
| 96.8 | N/A | N/A | N/A | (211/219) | ||||
| 96.3 | (0/160) | |||||||
| 0.0 | (0/52) | |||||||
| 0.0 | (8/219) | |||||||
| 3.7 |
Reproducibility and Quality Control demonstrated acceptable results.
H. 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.