(87 days)
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No
The description focuses on a miniaturized dilution technique and automated monitoring of bacterial growth, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is described as a "laboratory aid" for determining in vitro susceptibility to antimicrobial agents, which classifies it as an in vitro diagnostic device, not a therapeutic one.
Yes
The device is designed for antimicrobial susceptibility testing of Gram-positive microorganisms, determining in vitro susceptibility to antimicrobial agents, and providing MIC values, which are all diagnostic functions.
No
The device description clearly outlines physical components (VITEK® 2 AST Cards, VITEK® 2 and VITEK® 2 Compact Systems) and processes involving rehydrating media, filling, sealing, and incubating cards, which are hardware-dependent functions. The software component is part of a larger system that includes hardware for performing the antimicrobial susceptibility testing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it 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." This clearly describes a test performed in vitro (outside the body) on biological samples to provide information for diagnosis or treatment.
- Device Description: The description details a method for testing microbial growth in a laboratory setting using a miniaturized dilution technique.
- Intended User / Care Setting: The intended user is "clinical laboratories," which are the typical settings for performing IVD tests.
- Performance Studies: The document describes performance studies comparing the device to a reference method (CLSI broth microdilution), which is standard practice for validating IVD devices.
- Key Metrics: The key metrics listed (%EA, VME, ME, mE, %CA) are commonly used to evaluate the performance of antimicrobial susceptibility testing IVDs.
All 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 Dalbavancin 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 Dalbavancin is a quantitative test. Dalbavancin 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
Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis (vancomycin-susceptible isolates only) Streptococcus agalactiae
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 antimicrobial presented in VITEK® 2 AST-GP Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (20-24 hours for Streptococi and 16-20 hours for Staphylococci and Enterococci). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.
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 Dalbayancin by comparing its performance with the CLSI broth microdilution reference method incubated at 20-24 hours for Streptococci and 16-20 hours for Staphylococci and Enterococci.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-GP Dalbayancin 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 VITEK® 2 AST-GP Dalbavancin demonstrated acceptable performance as presented in Table 1 below:
Overall Performance (with the reference method): %EA 98.1, VME N/A, ME N/A, mE N/A, %CA 100.0, VME 0.0, ME 0.0, mE N/A.
Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Performance (with the reference method): %EA 98.1, %CA 100.0.
VME N/A, ME N/A, mE N/A for %EA
VME 0.0, ME 0.0, mE N/A for %CA
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.
VITEK® 2 AST-GP Ceftaroline (≤0.06 – ≥4 µg/mL) (K141149)
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.”
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June 6, 2019
bioMerieux, Inc. Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042
Re: K190616
Trade/Device Name: VITEK 2 AST-Gram Positive Dalbavancin (≤0.015 - ≥1 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: March 8, 2019 Received: March 11, 2019
Dear Cherece Jones:
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
1
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 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 (OS) 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,
for
Uwe Scherf, M.Sc., Ph.D. Director 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
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510(k) SUMMARY
VITEK® 2 AST-Gram Positive Dalbavancin (≤0.015 - ≥1 µg/mL)
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Cherece L. Jones |
| Staff Regulatory Affairs Specialist | |
| Phone Number: | 314 -731-8684 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | March 8, 2019 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Gram Positive Dalbavancin (≤0.015 - ≥1 µg/mL) |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code: LON | |
| Subsequent Product Codes: LTT LTW | |
| Common Name: | VITEK® 2 AST-GP Dalbavancin (≤0.015 - ≥1 µg/mL) |
| C. Predicate Device: | VITEK® 2 AST-GP Ceftaroline (≤0.06 – ≥4 µg/mL) |
| (K141149) |
D. 510(k) Summary:
VITEK® 2 AST-Gram Positive Dalbavancin 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 Dalbavancin is a quantitative test. Dalbavancin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
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Active both in vitro and in clinical infections
Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis (vancomycin-susceptible isolates only) Streptococcus agalactiae
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.
The antimicrobial presented in VITEK® 2 AST-GP Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (20-24 hours for Streptococi and 16-20 hours for Staphylococci and Enterococci). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.
VITEK® 2 AST-GP Dalbayancin 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-GP Dalbavancin. 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 Dalbayancin by comparing its performance with the CLSI broth microdilution reference method incubated at 20-24 hours for Streptococci and 16-20 hours for Staphylococci and Enterococci. The data is representative of performance on both the VITEK® 2 Compact instrument platforms.
The VITEK® 2 AST-GP Dalbavancin demonstrated acceptable performance as presented in Table 1 below:
| Overall Performance
(with the reference
| method) | %EA | VME | ME | mE | %CA | VME | ME | mE |
|---|---|---|---|---|---|---|---|---|
| 98.1 | N/A | N/A | N/A | 100.0 | 0.0 | 0.0 | N/A |
Table 1: VITEK® 2 AST-GP Dalbavancin Performance
Reproducibility and Quality Control demonstrated acceptable results.