(55 days)
No
The description focuses on a miniaturized doubling dilution technique and automated monitoring of bacterial growth, which are standard microbiological methods and do not indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
This device is a laboratory aid for antimicrobial susceptibility testing, providing diagnostic information rather than directly treating a condition.
Yes
This device is designed for antimicrobial susceptibility testing of specific bacteria (Staphylococcus aureus and Staphylococcus epidermidis), generating Minimum Inhibitory Concentration (MIC) values and interpretive categories, which are used as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This information helps determine effective treatments, thus aiding in diagnosis and treatment planning.
No
The device description clearly outlines physical components (VITEK 2 AST Cards, VITEK 2 System, VITEK 2 Compact) and processes involving physical manipulation of samples (diluting, filling, sealing, incubating). While software is involved in monitoring and generating reports, the core functionality relies on hardware and physical processes.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates it is used to test samples outside of the body to provide information for diagnosis or treatment.
- Device Description: The description details how the device tests bacterial isolates (samples taken from a patient) in a laboratory setting using a miniaturized microdilution technique.
- Performance Studies: The performance studies compare the device's results to a reference method (CLSI broth microdilution) using clinical isolates, further confirming its use in a diagnostic context.
The term "in vitro" in the intended use is a key indicator that this is an IVD.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-GP Clindamycin is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epidermidis. VITEK 2 AST-GP Clindamycin is a quantitative test 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. Clindamycin has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections Staphylococcus aureus (methicillin-susceptible strains) and Staphylococcus epidermidis (methicillin-susceptible strains)
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK 2 Compact 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 agalactiae, and S. pneumoniae.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
VITEK 2 AST - Gram Positive Clindamycin is designed for an antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epidermidis. 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 antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcq/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 bacterial 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.
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 and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK AST - Gram Positive Clindamycin for Staphylococcus aureus and Staphylococcus epidermidis by comparing its performance with the CLSI broth microdilution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 AST - Gram Positive Clindamycin for Staphylococcus aureus and Staphylococcus epidemidis demonstrated substantially equivalent performance with the CLSI broth microdilution reference method, as defined in the 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, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK 2 AST - Gram Positive Clindamycin for Staphylococcus aureus and Staphylococcus epidermidis demonstrated acceptable performance of 99.4% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99.4% overall Category Agreement
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 Gram Positive Linezolid (K032766)
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.
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
KI22547
Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of the word "BIOMERIEUX" in a sans-serif font, with a stylized globe above it. The globe is divided into two halves, one with horizontal lines and the other solid black. A curved line passes through the globe and the text.
OCT 1 5 2012
510(k) SUMMARY
VITEK® 2 AST- Gram Positive Clindamycin
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 100 Rodolphe Street |
| Durham, NC 27712 |
Contact Person:
Phone Number:
Fax Number:
Date of Preparation:
tham, NC 27712
Elizabeth (Betty) Landon Staff Regulatory Affairs Specialist
VITEK® 2 AST - Gram Positive Clindamycin
VITEK® 2 Gram Positive Linezolid (K032766)
919-620-2329
919-620-2548
Auqust 20, 2012
21 CFR 866.1645
Product Code LON
Antimicrobial Susceptibility Test
VITEK® 2 AST - GP Clindamycin
B. Device Name:
· Formal/Trade Name:
Classification Name:
Common Name:
C. Predicate Device:
D. 510(k) Summary:
VITEK 2 AST - Gram Positive Clindamycin is designed for an antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epidermidis. 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 antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcq/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 bacterial 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 - Gram Positive Clindamycin for Staphylococcus aureus and Staphylococcus epidemidis demonstrated substantially equivalent performance with the CLSI broth microdilution reference method, as defined in the 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 - Gram Positive Clindamycin for Staphylococcus aureus and Staphylococcus epidermidis. An external evaluation was
bioMérieux, Inc. 100 Rodolphe Street, Durham, Allyge Zag & Tridge Phone: 919 620 2000 http://www.biomerieux-usa.com
1
conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK AST - Gram Positive Clindamycin for Staphylococcus aureus and Staphylococcus epidermidis by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK 2 AST - Gram Positive Clindamycin for Staphylococcus aureus and Staphylococcus epidermidis demonstrated acceptable performance of 99.4% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 15, 2012
CT 15 2012
bioMérieux, Inc. c/o Elizabeth Landon Staff Regulatory Affairs Specialist 595 Anglum Road Hazelwood, MO 63042
Re: K122547
Trade/Device Name: VITEK®2 AST- Gram Positive Clindamycin (≤ 0.12-≥4 µg/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LON Dated: August 20, 2012 Received: August 21, 2012
Dear Landon:
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. 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Elizabeth Landon
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Uwe Scherf for
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: VITEK® 2 AST - Gram Positive Clindamycin (