(229 days)
No
The description focuses on automated quantitative or qualitative susceptibility testing using miniaturized microdilution methodology and monitoring growth over time. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is designed for in vitro diagnostic testing to determine antimicrobial susceptibility, not to provide therapy or treatment to a patient.
Yes
The device aids in the determination of in vitro susceptibility of Streptococcus pneumoniae to antimicrobial agents, which is a diagnostic activity used to guide treatment.
No
The device description explicitly mentions "VITEK 2 AST Cards" which are physical components containing antimicrobial medium, and the "VITEK 2 System" and "VITEK 2 Compact" which are instruments that process these cards. This indicates the device includes hardware components and is not software-only.
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." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The device description details how it tests bacterial isolates diluted in saline, outside of a living organism.
- Function: The device determines the minimum inhibitory concentration (MIC) of an antimicrobial agent against a specific microorganism, which is a standard in vitro diagnostic test for guiding treatment decisions.
- User/Setting: It is intended for use as a "laboratory aid," indicating it is used in a laboratory setting for diagnostic purposes.
- Performance Studies: The performance studies compare the device's performance to a "CLSI broth microdilution reference method," which is another established in vitro diagnostic technique.
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 Penicillin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae 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. Penicillin has been shown to be active against most strains of the microorqanism listed below, according to the FDA label for this antimicrobial.
Streptococcus pneumoniae (pneumonia and meningitis)
• 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 Gram Positive Penicillin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. 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 antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK 2 AST Cards are essentially miniaturized versons 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 cycle, a report is generated that contains the MC 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 isolat4es and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Penicillin for Streptococcus pneumoniae 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 Gram Positive Penicillin for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared 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 Gram Positive Penicillin for Streptococcus pneumoniae demonstrated acceptable performance of 92.3% and 96.9% Category Agreement based on the pneumonia and meninatis breakpoints, respectively. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
92.3% and 96.9% 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.
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
K//3783
Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of a stylized graphic above the company name. The graphic is a circle split into two halves, with one half filled with vertical lines and the other half solid black. A curved line runs vertically through the center of the circle and extends downwards. The company name "BIOMERIEUX" is written in a stylized font below the graphic.
7 2012 AUG
510(k) SUMMARY
VITEK® 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae
510(k) Submission Information:
Submitter's Name:
Address:
bioMérieux, Inc.
919-620-2329
919-620-2548
pneumoniae
December 20, 2011
100 Rodolphe Street Durham, NC 27712
Elizabeth (Betty) Landon Staff Regulatory Affairs Specialist
Phone Number:
Fax Number:
Contact Person:
Date of Preparation:
B. Device Name:
Formal/Trade Name:
Classification Name:
21 CFR 866.1645 Antimicrobial Susceptibility Test Product Code LON
Common Name:
C. Predicate Device:
VITEK® 2 Gram Positive Amoxicillin for Streptococcus pneumoniae (K063597)
VITEK 2 AST-GP Penicillin for Streptococcus pneumoniae
VITEK® 2 AST - Gram Positive Penicillin for Streptococcus
D. 510(k) Summary:
VITEK 2 Gram Positive Penicillin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. 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 antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK 2 AST Cards are essentially miniaturized versons 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 cycle, a report is generated that contains the MC value along with the interpretive category result for each antibiotic contained on the card.
VITEK 2 Gram Positive Penicillin for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the
1
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 Gram Positive Penicillin for Streptococcus pneumoniae. An external evaluation was conducted with fresh and stock clinical isolat4es and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Penicillin for Streptococcus pneumoniae 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 Gram Positive Penicillin for Streptococcus pneumoniae demonstrated acceptable performance of 92.3% and 96.9% Category Agreement based on the pneumonia and meninatis breakpoints, respectively. Reproducibility and Quality Control demonstrated acceptable results.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and well-being.
10903 New Hampshire Avenue Silver Spring, MD 20993
bioMerieux, Inc. c/o Elizabeth Landon 100 Rodolphe Street Durham, NC 27712
AUG 7 2012
K113783 Re:
Trade Name: VITEK® 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae Regulation Number: 21 CFR §866.1645 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Codes: LON Dated: July 24, 2012 Received: July 26, 2012
Dear Ms. 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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Uwe. Sick for
Sally A. Hojvat, M.Sc., Ph.D Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known):_ k l(3 7 8 3
Device Name: VITEK® 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae ( ≤ 0.06 -- ≥ 8 µg/mL )
Indications For Use:
VITEK® 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae 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. Penicillin has been shown to be active against most strains of the microorqanism listed below, according to the FDA label for this antimicrobial.
Streptococcus pneumoniae (pneumonia and meningitis)
· 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.
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Leesdale Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113783
Page 1 of 1