(98 days)
Not Found
No
The device description details a microdilution technique based on established methods and automated processes for reading growth, without mentioning any AI or ML components for analysis or interpretation. The performance studies focus on agreement with a reference method, not on validating an AI/ML algorithm.
No.
The device is for in vitro diagnostic (IVD) use and helps determine antimicrobial susceptibility, which is a laboratory aid rather than a direct therapeutic intervention.
Yes
The device aids in determining in vitro susceptibility to antimicrobial agents for Gram positive microorganisms, providing a Minimum Inhibitory Concentration (MIC) value and interpretive category result for each antibiotic. This information is used for diagnostic purposes in clinical laboratories to guide treatment decisions.
No
The device description clearly details a physical card with wells containing antimicrobial agents and culture media, which is processed by a hardware system (VITEK® 2 Systems). This is a hardware-based in vitro diagnostic device, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is "designed for antimicrobial susceptibility testing of Gram positive microorganisms" 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. It also mentions being an "in vitro test" in the description of the Gram-positive Susceptibility Card.
- Device Description: The description details a test performed on a sample (bacterial or yeast isolate) outside of the body ("in vitro") using a specific card containing reagents (antibiotics and culture media).
- Intended User/Care Setting: The intended users are "clinical laboratories," which are settings where in vitro diagnostic tests are typically performed.
- Summary of Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution 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 Daptomycin is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Daptomycin is a quantitative test. Daptomycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections: Enterococcus faecalis (vancomycin-susceptible isolates only) Staphylococcus aureus (including methicillin-resistant isolates)
In vitro data are available, but their clinical significance is unknown: Enterococcus faecalis (vancomycin-resistant isolates)
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 (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(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 Daptomycin has the following concentrations in the card: 0.5, 1, 2, 4, and 8 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 as an in vitro test
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 Daptomycin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-GP Daptomycin demonstrated substantially equivalent performance when compared with the 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 (PMA) presents data in support of VITEK® 2 AST-GP Daptomycin. The data is representative of performance on both the VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GP Daptomycin (
§ 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".
July 5, 2023
BioMerieux, Inc Jared Bronson Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K230864
Trade/Device Name: VITEK 2 AST-Gram Positive Daptomycin (=8 ug/mL), VITEK 2 AST-GP Daptomycin (=8 µg/mL), VITEK 2 AST-GP Daptomycin 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: March 22, 2023 Received: March 29, 2023
Dear Jared Bronson:
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 -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics 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-GP Daptomycin (≤0.12 - ≥8 µg/mL)
Indications for Use (Describe)
VITEK® 2 AST-Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Daptomycin is a quantitative test. Daptomycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections: Enterococcus faecalis (vancomycin-susceptible isolates only) Staphylococcus aureus (including methicillin-resistant isolates)
In vitro data are available, but their clinical significance is unknown: Enterococcus faecalis (vancomycin-resistant isolates)
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.
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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3
Image /page/3/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle with the top half in dark blue and the bottom half in yellow-green. The company name, "BIOMÉRIEUX", is written in white, sans-serif font in the center of the blue portion of the circle.
510(k) SUMMARY
VITEK® 2 AST-GP Daptomycin (≤ 0.121 -> 8 µg/mL)
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jared Bronson |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-201-8799 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | June 12, 2020 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-GP Daptomycin (≤0.12 - ≥8 µg/mL) |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code: LON, LTT, LTW | |
| Common Name: | VITEK® 2 AST-GP Daptomycin |
| C. Predicate Device: | VITEK® 2 AST-GP Daptomycin (≤0.12 - ≥8 µg/mL) |
| (K091126) |
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).
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
4
Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with the top half in dark blue and the bottom half in yellow and green. The word "BIOMÉRIEUX" is written in white letters in the center of the blue portion of the circle.
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 Daptomycin has the following concentrations in the card: 0.5, 1, 2, 4, and 8 ug/mL (equivalent standard method concentration by efficacy in ug/mL).
E. Substantial Equivalence Information:
The similarities and differences of the VITEK® 2 AST-GP Daptomycin when compared to the predicate device, VITEK®2 AST-GP Daptomycin (K091126), are described in the following table. There is no difference between the new device and the predicate device.
| Device and Predicate Device(s): | Device: | Predicate Device: K091126 |
|---|---|---|
| Device Trade Name | VITEK® 2 AST-GP Daptomycin | |
| (≤0.12 - ≥8 µg/mL) | VITEK® 2 AST-GP Daptomycin | |
| (≤0.12 - ≥8 µg/mL) | ||
| Intended Use/Indications for Use | VITEK® 2 AST-GP Daptomycin 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-GP Daptomycin is a quantitative test. Daptomycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. |
The VITEK® 2 Gram Positive Susceptibility Card is intended for use with the VITEK® 2 Systems in | Same |
Table 1: Substantial Equivalence
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Image /page/5/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.
| clinical laboratories as an in vitro test
to determine the susceptibility of
Enterococcus spp., Staphylococcus
spp., and Streptococcus 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 | Daptomycin | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | Gram-positive (AST-GP) Susceptibility | |
| Card | Same | |
| Instrument | VITEK® 2 and VITEK® 2 Compact | |
| Systems | Same | |
| Analysis Algorithms | Discriminant Analysis | Same |
| Type of Test | Quantitative | Same |
| Concentrations | 0.5, 1, 2, 4, 16 | Same |
| General Device Characteristic Differences | ||
| Breakpoints | Staphylococcus aureus | |
| (S/I/R) $\leq$ 1 / - / - | Staphylococcus aureus | |
| (S/I/R) $\leq$ 1 / - / - | ||
| Enterococcus faecalis | ||
| (S/I/R) $\leq$ 2 / 4 / > 8 | Enterococcus faecalis | |
| (S/I/R) $\leq$ 4 / - / - | ||
| Indicated Organisms | Active both in vitro and in clinical | |
| infections: | ||
| Enterococcus faecalis (vancomycin- | ||
| susceptible isolates only) | ||
| Staphylococcus aureus (including | ||
| methicillin-resistant isolates) |
In vitro data are available. but their
clinical significance is unknown:
Enterococcus faecalis (vancomycin-
resistant isolates) | Active both in vitro and in clinical
infections:
Enterococcus faecalis (vancomycin-
susceptible isolates only)
Staphylococcus aureus (including
methicillin-resistant isolates) |
F. Intended Use:
VITEK® 2 AST-GP Daptomycin 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.
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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 yellow-green circle on the bottom, separated by a white line. The word "BIOMÉRIEUX" is written in white letters in the center of the blue circle.
VITEK® 2 AST-GP Daptomycin is a quantitative test. Daptomycin has been shown to be active against the microorganisms listed below, according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections: Enterococcus faecalis (vancomycin-susceptible isolates only) Staphylococcus aureus (including methicillin-resistant isolates)
In vitro data are available, but their clinical significance is unknown: Enterococcus faecalis (vancomycin-resistant isolates)
The VITEK® 2 AST-GP Daptomycin Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Enterococcus spp., Staphylococcus spp., and Streptococcus agalactiae to antimicrobial agents when used as instructed.
G. Performance Overview and Conclusion:
VITEK® 2 AST-GP Daptomycin demonstrated substantially equivalent performance when compared with the 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 (PMA) presents data in support of VITEK® 2 AST-GP Daptomycin. 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 Daptomycin 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 Compact instrument platforms.
VITEK® 2 AST-GP Daptomycin (