(169 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 interpretation or analysis.
No.
This device is designed for in vitro antimicrobial susceptibility testing, which aids in determining the effectiveness of antimicrobial agents against specific microorganisms, not for direct therapeutic use on a patient.
Yes
This device is designed for antimicrobial susceptibility testing of Gram-negative bacilli to determine their susceptibility to antimicrobial agents. This information aids in diagnosing which antimicrobials will be effective against a particular infection.
No
The device description clearly states that the VITEK® 2 AST card is a physical component containing wells with antibiotic and culture media, and the system involves physical processes like filling, sealing, and incubation. This indicates a hardware component 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 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.
- Care Setting: The intended user is in "clinical laboratories," which is a typical setting for performing in vitro diagnostic tests.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard laboratory method for determining antimicrobial susceptibility in vitro.
All of these points strongly indicate that the VITEK® 2 AST-Gram Negative Omadacycline is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Gram Negative Omadacycline 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 Omadacycline in is a quantitative test. Omadacycline 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:
For Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Enterobacter cloacae Klebsiella pneumoniae For Community Acquired Bacterial Pneumonia (CABP): Klebsiella pneumoniae
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 (comma separated list FDA assigned to the subject device)
LON, LTW, LTT
Device Description
The principle of the VITEK®2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh() 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 Omadacycline (≤0.25 - >16 µg/mL) has the following concentrations in the card: 0.5, 2. 8 and 16 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
Use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. 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 Omadacycline by comparing its performance with the CLSI broth microdilution reference method incubated at 16-24 hrs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-GN Omadacycline 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).
Performance in terms of Essential Agreement (%EA) and Category Agreegment (%CA) for Omadacycline (OMC omc01n):
ABSSSI E. cloacae / K. pneumoniae:
- %EA: 97.9 (410/419)
- %CA: 94.3 (395/419)
- VME: 2.0 (1/51)
- ME: 0.0 (0/343)
- mE: 5.5 (23/419)
CABP K. pneumoniae:
- %EA: 98.0 (342/349)
- %CA: 93.7 (327/349)
- VME: 2.7 (1/37)
- ME: 0.0 (0/290)
- mE: 6.0 (21/349)
Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) %, Category Agreement (CA) %, Very Major Error (VME), Major Error (ME), Minor Error (mE).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
June 3, 2022
bioMérieux, Inc. Nathan Hardesty Associate Director, Regulatory Affairs 595 Anglum Road Hazelwood, Missouri 63042
Re: K213931
Trade/Device Name: VITEK 2 AST-Gram Negative Omadacycline (16 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 Dated: December 15, 2021 Received: December 16, 2021
Dear Nathan Hardesty:
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 medical devices and radiation-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 Omadacycline (≤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: | July 25, 2021 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Gram Negative Omadacycline (≤0.25 - |
| ≥16 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 Omadacycline (≤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() 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 upper half and a yellow-green lower half. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle.
Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.
VITEK® 2 AST-GN Omadacycline (≤0.25 - >16 µg/mL) has the following concentrations in the card: 0.5, 2. 8 and 16 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 Omadacycline (≤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
Omadacycline
( $\leq$ 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
Omadacycline 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 Omadacycline
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 | 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 |
| Item | Device:
VITEK® 2 AST-Gram Negative
Omadacycline
(≤0.25 - ≥16 µg/mL) | Predicate:
VITEK® 2 AST-GN
Eravacycline
(≤0.12 - ≥4 µg/mL)
(K191766) |
| Similarities | | |
| | clinically significant aerobic Gram
negative bacilli to antimicrobial
agents when used as instructed. | 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 |
| 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 | Omadacycline | Eravacycline |
| Concentrations | 0.5, 2, 8, 16 | 0.25, 1, 2, 4 |
| Indications for use | Omadacycline 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:
For ABSSSI:
Enterobacter cloacae
Klebsiella pneumoniae
For CABP:
Klebsiella pneumoniae | 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) |
| Item | Device:
VITEK® 2 AST-Gram Negative
Omadacycline
(≤0.25 - ≥16 µg/mL) | Predicate:
VITEK® 2 AST-GN
Eravacycline
(≤0.12 - ≥4 µg/mL)
(K191766) |
| Similarities | | |
| aerogenes | | |
Table 1: Substantial Equivalence
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VITEK® 2 AST-GN Omadacycline
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F. Intended Use:
VITEK® 2 AST-Gram Negative Omadacycline 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 Omadacycline in is a quantitative test. Omadacycline 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:
For Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Enterobacter cloacae Klebsiella pneumoniae For Community Acquired Bacterial Pneumonia (CABP): Klebsiella pneumoniae
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 Omadacycline 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 Omadacycline. 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 Omadacycline by comparing its performance with the CLSI broth microdilution reference
7
Image /page/7/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a blue circle at the top, with the company name "BIOMÉRIEUX" in white, sans-serif font. The bottom half of the circle transitions from yellow to green, creating a gradient effect. The overall design is simple and modern, reflecting the company's focus on innovation in the field of diagnostics.
method incubated at 16-24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
The VITEK® 2 AST-GN Omadacycline demonstrated acceptable performance as presented in Table 2 below:
| Antimi-
crobial | Antimi-
crobial
code | Antimi-
crobial
Version | Comment | Essential Agreement Category
% Error | | | | Category Agreement
% Error | | | |
|--------------------|----------------------------|-------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------|----------------|----------------|----------------|--------------------------------------------|------------------------------------------|--------------------------------------|----------------------------------------|
| | | | | %EA | VME | ME | mE | %CA | VME | ME | mE |
| Omada-
cycline | OMC | omc01n | ABSSSI
E. cloacae *
K. pneumoniae
CABP
K. pneumoniae | 97.9
(410/419)
98.0
(342/349) | N/A
N/A | N/A
N/A | N/A
N/A | 94.3
(395/419)
93.7
(327/349) | 2.0 **
(1/51)
2.7 **
(1/37) | 0.0
(0/343)
0.0
(0/290) | 5.5
(23/419)
6.0
(21/349) |
Table 2: VITEK® 2 AST-GN Omadacycline Performance
Reproducibility and Quality Control demonstrated acceptable results.
H. References:
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-
- 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, 3. Philadelphia, PA, 1976.