(160 days)
Not Found
No
The description focuses on automated microdilution techniques and growth monitoring, with no mention of AI or ML algorithms for interpretation or analysis. The performance studies compare the device to a reference method, not an AI/ML model.
No.
This device is a laboratory aid for determining the in vitro susceptibility of microorganisms to antimicrobial agents, which assists in diagnosis rather than directly providing therapy.
Yes
The device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents" and is used for "automated quantitative or qualitative susceptibility testing of isolated colonies," which are diagnostic processes.
No
The device description clearly outlines physical components like "VITEK® 2 AST Cards," a "VITEK® 2" system, and a "VITEK® 2 Compact" system, which are hardware. The process involves physical steps like diluting isolates, rehydrating media within the card, and the system automatically filling, sealing, and incubating the card. This is not a software-only device.
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" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates it is used to test samples taken from the human body (in this case, bacterial isolates) outside of the body to provide information about a person's health status (specifically, how susceptible bacteria are to certain antibiotics).
- Device Description: The description details how the device works by testing bacterial isolates in a miniaturized microdilution methodology, which is a standard in vitro diagnostic technique for determining antimicrobial susceptibility.
- Performance Studies: The performance studies compare the device's performance to a "CLSI broth microdilution reference method," which is another established in vitro diagnostic method.
- Intended User/Care Setting: It is intended for use as a "laboratory aid," indicating it is used in a clinical laboratory setting for diagnostic purposes.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 AST- Gram Positive Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus aureus, Staphylococcus lugdunensis, and Coagulase Negative Staphylococcus spp. VITEK® 2 AST- Gram Positive Inducible Clindamycin Resistance is a qualitative test. It 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 VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and yeast.
Product codes (comma separated list FDA assigned to the subject device)
LON, LTW, LTT
Device Description
VITEK® 2 Gram Positive Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus aureus, and Staphylococcus lugdunensis, and Coagulase Negative Staphylococcus spp. VITEK® 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test. It 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 VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and yeast.
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 (up to 18 hours). At the completion of the incubation cvcle, 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
Not Found
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 Inducible Clindamycin Resistance 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 Inducible Clindamycin Resistance 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 data is representative of performance on both the VITEK®2 and VITEK®2 Compact instrument platforms.
Overall Performance (with the reference method): %EA N/A, VME N/A, ME N/A, mE 97.7, %CA 1.5, VME 2.4, ME N/A, mE N/A
Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.”
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December 10, 2018
bioMerieux, Inc Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K181766
Trade/Device Name: VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance 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: December 5, 2018 Received: December 6, 2018
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Steven R. Gitterman -S for
Uwe Scherf, M. Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181766
Device Name
VITEK® 2 AST- Gram Positive Inducible Clindamycin Resistance
Indications for Use (Describe)
VITEK® 2 AST- Gram Positive Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus aureus, Staphylococcus lugdunensis, and Coagulase Negative Staphylococcus spp. VITEK® 2 AST- Gram Positive Inducible Clindamycin Resistance is a qualitative test. It 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 VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and yeast.
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
VITEK® 2 AST-GP Inducible Clindamycin Resistance
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: | November 16, 2018 |
| 1. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Gram Positive Inducible Clindamycin |
| Resistance | |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code: LON | |
| Common Name: | VITEK® 2 AST-GP Inducible Clindamycin Resistance |
| 2. Predicate Device: | VITEK® 2 AST-ST Inducible Clindamycin Resistance |
| (K111909) |
D. 510(k) Summary:
B.
C.
VITEK® 2 Gram Positive Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus aureus, and Staphylococcus lugdunensis, and Coagulase Negative Staphylococcus spp. VITEK® 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test. It 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 VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies
4
for the most clinically significant aerobic Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and yeast.
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 (up to 18 hours). At the completion of the incubation cvcle, 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 Inducible Clindamycin Resistance 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 Inducible Clindamycin Resistance. 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 Inducible Clindamycin Resistance 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-GP Inducible Clindamycin Resistance demonstrated acceptable performance as presented in Table 1 below:
| Overall Performance
(with the reference
| method) | %EA | VME | ME | mE | %CA | VME | ME | mE |
|---|---|---|---|---|---|---|---|---|
| N/A | N/A | N/A | N/A | 97.7 | 1.5 | 2.4 | N/A |
Table 1: VITEK® 2 AST-GP Inducible Clindamycin Resistance Performance
Reproducibility and Quality Control demonstrated acceptable results.