(150 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 an in vitro diagnostic (IVD) device used in clinical laboratories to determine the susceptibility of microorganisms to antimicrobial agents, which is a laboratory aid for treatment decisions, not a direct therapeutic intervention.
Yes
The device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents" and is used to determine the "susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents." This information is used to inform treatment decisions, which is a diagnostic purpose.
No
The device description clearly outlines 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-dependent process.
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 positive microorganisms" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a test performed on a sample (bacterial or yeast isolate) outside of the body, using a specific medium and antibiotic concentrations within a card. This is characteristic of an in vitro test.
- Care Setting: The intended user is specified as "clinical laboratories," which are common settings for performing in vitro diagnostic tests.
- Performance Studies: The performance studies compare the device's results to a "CLSI agar dilution reference method," which is a standard laboratory method for in vitro susceptibility testing.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Gram Positive Linezolid is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Linezolid is a quantitative test. Linezolid 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:
Enterococcus faecium (vancomycin-resistant isolates only)
Staphylococcus aureus (including methicillin-resistant isolates)
Streptococcus agalactiae
In vitro data are available, but clinical significance is unknown:
Enterococcus faecalis (including vancomycin-resistant isolates)
Enterococcus faecium (vancomycin-susceptible isolates)
Staphylococcus epidermidis (including methicillin-resistant isolates)
Staphylococcus haemolyticus
The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
Product codes
LON
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-GP Linezolid has the following concentrations in the card: 0.5, 1, and 2 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-GP Linezolid by comparing its performance with the CLSI agar dilution reference method incubated at 16-20 hours (20-24 hours for Streptococcus agalactiae). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Premarket Notification (Special 510[k]) presents data in support of VITEK® 2 AST-GP Linezolid. 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-GP Linezolid by comparing its performance with the CLSI agar dilution reference method incubated at 16-20 hours (20-24 hours for Streptococcus agalactiae). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
VITEK® 2 AST-GP Linezolid (≤0.5 ->8 µg/mL) demonstrated acceptable performance as presented in Table 2 below:
Enterococcus spp.:
Essential Agreement: (402/403) 99.8%
Category Agreement: (395/403) 98.0%
% Error VME: (0/8) 0.0%
% Error ME: (0/389) 0.0%
% Error mE: (8/403) 2.0%
Staphylococcus spp.:
Essential Agreement: (379/390) 97.2%
Category Agreement: (389/390) 99.7%
% Error VME: (0/11) 0.0%
% Error ME: (1/379) 0.3%
% Error mE: (0/390) 0.0%
% Reproducibility: 100%
Streptococcus agalactiae:
Essential Agreement: (64/64) 100%
Category Agreement: (64/64) 100%
% Error VME: (0/0) 0.0%
% Error ME: (0/64) 0.0%
% Error mE: (0/64) 0.0%
VITEK 2 AST-Gram Positive Linezolid MIC values tended to be in exact agreement or at least one doubling dilution higher when testing Staphylococcus haemolyticus compared to the CLSI reference agar dilution method. When evaluating performance of the clinical and challenge isolates, testing with Staphylococcus Haemolyticus isolates yielded an EA of 82.9% (29/35) and a CA of 97.1% (34/35). There was one major error (2.9%%, 1/35).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA)
Category Agreement (CA)
Very Major Error (VME)
Major Error (ME)
Minor Error (mE)
Reproducibility
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.”
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Image /page/0/Picture/0 description: The image contains 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.
February 4, 2022
bioMérieux, Inc Esther Hernandez Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K212849
Trade/Device Name: VITEK 2 AST-Gram Positive Linezolid (8 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: September 8, 2021 Received: September 9, 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., D(ABMM), F(AAM) Branch Chief 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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Image /page/3/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a blue circle on top and a yellow-green gradient circle on the bottom. The word "BIOMÉRIEUX" is written in white letters inside the blue circle.
VITEK® 2 AST-GP Linezolid Special 510(k) Submission
510(k) SUMMARY
VITEK® 2 AST-GP Linezolid
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: | September 03, 2021 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST- Gram Positive Linezolid (≤ 0.5 -> 8 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-GP Linezolid |
| Predicate Device: | VITEK® 2 AST-GP Linezolid (K032766) |
D. Device Description:
B.
C.
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
4
Image /page/4/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a blue semi-circle at the top with the company name "BIOMÉRIEUX" in white text. Below the blue semi-circle is a yellow-green semi-circle, creating a circular shape overall.
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-GP Linezolid has the following concentrations in the card: 0.5, 1, and 2 ug/mL (equivalent standard method concentration by efficacy in us/mL).
E. Substantial Equivalence Information
The similarities and differences of the VITEK 2 AST-GP Linezolid when compared to the predicate device. VITEK 2 AST-GP Linezolid (K032766), are described in the following table. The only difference between both devices is the change in breakpoints for Staphylococcus species.
| Device and Predicate
| Device(s): | Device: K212849 | Predicate Device: K032766 |
|---|---|---|
| Device Trade Name | VITEK 2 AST-GP Linezolid | VITEK 2 AST-GP Linezolid |
| General Device Characteristic Similarities | ||
| Intended Use/Indications | ||
| for Use | VITEK® 2 AST-Gram Positive | |
| Linezolid is designed for antimicrobial | ||
| susceptibility testing of Gram positive | ||
| microorganisms 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 Positive | ||
| Linezolid is a quantitative test. | ||
| Linezolid has been shown to be active | ||
| against most strains of the | ||
| microorganisms listed below, | ||
| according to the FDA label for this | ||
| antimicrobial. | Intended use(s): | |
| The VITEK 2 Antimicrobial | ||
| Susceptibility Test (AST) is intended to | ||
| be used with the VITEK 2 System for | ||
| the automated quantitative or qualitative | ||
| susceptibility testing of isolated colonies | ||
| for most clinically significant aerobic | ||
| gram-negative bacilli, Staphylococcus | ||
| spp. , Enterococcus spp. , Streptococcus | ||
| agalactiae , and S. pneumoniae . | ||
| The VITEK 2 Gram Positive | ||
| Susceptibility Card is intended for use | ||
| with the | ||
| VITEK 2 System in clinical laboratories | ||
| as an in vitro test to determine the | ||
| susceptibility of Staphylococcus spp. , | ||
| Enterococcus spp. , and S. agalactiae to | ||
| antimicrobial agents when used as | ||
| Active in vitro and in clinical | ||
| infections: | ||
| Enterococcus faecium (vancomycin- | ||
| resistant isolates only) | ||
| Staphylococcus aureus (including | ||
| methicillin-resistant isolates) | ||
| Streptococcus agalactiae | instructed in the Online Product | |
| Information. | ||
| Indication(s) for use: | ||
| The indication will include the testing of | ||
| linezolid at concentrations of 0.5, 1, and | ||
| 2 for a calling range of 8 | ||
| µg/ml on the VITEK 2 Gram Positive | ||
| Susceptibility Card. | ||
| In vitro data are available, but clinical | ||
| significance is unknown: | ||
| Enterococcus faecalis (including | ||
| vancomycin-resistant isolates) | ||
| Enterococcus faecium (vancomycin- | ||
| susceptible isolates) | ||
| Staphylococcus epidermidis (including | ||
| methicillin-resistant isolates) | ||
| Staphylococcus haemolyticus | ||
| The VITEK® 2 Gram-positive | ||
| Susceptibility Card is intended for use | ||
| with the VITEK® 2 Systems in clinical | ||
| laboratories as an in vitro test to | ||
| determine the susceptibility of | ||
| Staphylococcus spp., Enterococcus | ||
| spp., and S. agalactiae 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 | Linezolid | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | Gram-positive (AST-GP) Susceptibility | |
| Card | Same | |
| Analysis Algorithms | Discriminant Analysis | Same |
| Instrument | VITEK® 2 and VITEK® 2 Compact | |
| Systems | Same | |
| Concentrations | 0.5, 1, 2 | Same |
| General Device Characteristic Differences | ||
| Staphylococcus spp. | S ≤ 4, I -, R >8 µg/mL | Susceptible-only category |
Table1: Substantial Equivalence
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Image /page/5/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a blue semi-circle at the top with the company name "BIOMÉRIEUX" in white text. Below the blue semi-circle is a semi-circle that transitions from yellow to green.
VITEK® 2 AST-GP Linezolid Special 510(k) Submission
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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 of a yellow-green circle. The word "BIOMÉRIEUX" is written in white letters inside the blue circle.
VITEK® 2 AST-GP Linezolid Special 510(k) Submission
| Breakpoints | S 8 µg/mL) demonstrated acceptable performance as presented in Table 2 below:
| Antimicrobial | Comment | Essential Agreement | | | | Category Agreement | | | | %
Reproducibility |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|---------------------|-----|-----|-----|--------------------|----------------|-----------------|-----------------|----------------------|
| | | %Error | | | | % Error | | | | |
| | | %EA | VME | ME | mE | %CA | VME | ME | mE | |
| Linezolid | #, E
Enterococcus
spp. | (402/403)
99.8% | N/A | N/A | N/A | (395/403)
98.0% | (0/8)
0.0% | (0/389)
0.0% | (8/403)
2.0% | |
| | #, E
Staphylococcus
spp. | (379/390)
97.2% | N/A | N/A | N/A | (389/390)
99.7% | (0/11)
0.0% | (1/379)
0.3% | (0/390)
0.0% | 100% |
| | #, E
Streptococcus
agalactiae | (64/64)
100% | N/A | N/A | N/A | (64/64)
100% | (0/0)
0.0% | (0/64)
0.0% | (0/64)
0.0% | |
| VITEK 2 AST-Gram Positive Linezolid MIC values tended to be in exact agreement or at least one doubling dilution higher when
testing Staphylococcus haemolyticus compared to the CLSI reference agar dilution method.
When evaluating performance of the clinical and challenge isolates, testing with Staphylococcus haemolyticus isolates yielded an EA
of 82.9% (29/35) and an CA of 97.1% (34/35). There was one major error (2.9%%, 1/35). | | | | | | | | | | |
Table 2: VITEK® 2 AST-GP Linezolid Performance
Key
= US Food and Drug Administration 510(k) cleared
E = External performance data
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.
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