(220 days)
VITEK® 2 Gram Positive Amoxicillin for Streptococcus pneumoniae (K063597)
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 algorithms being used for analysis or interpretation.
No.
This device is designed for antimicrobial susceptibility testing in a laboratory setting to aid in determining in vitro susceptibility, not to treat or diagnose patients.
Yes
The device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," which directly relates to diagnosing an organism's resistance or susceptibility to drugs, a key part of diagnostic testing. Also, the "Intended Use" section explicitly states "Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK 2 System 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 clinically significant yeast," which is a diagnostic function.
No
The device description explicitly mentions hardware components like the VITEK® 2 and VITEK® 2 Compact Systems, which are automated instruments used for filling, sealing, incubating, and reading the AST cards. The device is the AST card itself, which contains the antimicrobial medium, and is used with these hardware systems.
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 directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details how the device tests isolated colonies of microorganisms (specimens) in a laboratory setting to determine their susceptibility to antimicrobial agents. This process is performed in vitro (outside the body).
- Performance Studies: The performance studies compare the device's results to a reference method for determining antimicrobial susceptibility, further confirming its role in laboratory testing for diagnostic purposes.
The information provided clearly indicates that this device is designed and used for testing biological specimens in vitro to provide information relevant to patient care, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
VITEK® 2 Streptococcus Erythromycin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK 2 Streptococcus Erythromycin 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. Erythromycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections Streptococcus pneumoniae Streptococcus pyogenes
Active in vitro but clinical significance unknown Viridans group Streptococci
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System 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 clinically significant yeast.
Product codes
LON
Device Description
The antimicrobial presented in VITEK 2 AST-ST Cards is in concentrations equivalent by efficacy to standard method concentrations in ug/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 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
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 Streptococcus Erythromycin by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 Streptococcus Erythromycin 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 Streptococcus Erythromycin. 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 Streptococcus Erythromycin by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 Streptococcus Erythromycin demonstrated acceptable performance of 97.9% overall Essential Agreement and 96.7% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results using both the VITEK 2 Compact instrument svstems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
97.9% overall Essential Agreement and 96.7% overall Category Agreement with the reference method.
Predicate Device(s)
VITEK® 2 Gram Positive Amoxicillin for Streptococcus pneumoniae (K063597)
Reference Device(s)
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.”
0
K 111976
Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of the word "BIOMERIEUX" in a stylized font, with a vertical line running through the middle of the word. Above the word is a circle that is half black and half white with lines.
FEB 1 7 2012
510(k) SUMMARY
VITEK® 2 Streptococcus Erythromycin
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jennifer Chia-Hsuan Lin |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8639 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | July 1, 2011 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 Streptococcus Erythromycin |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code LON | |
| Common Name: | VITEK® 2 AST-ST Erythromycin |
| Predicate Device: | VITEK® 2 Gram Positive Amoxicillin for Streptococcus |
| pneumoniae (K063597) |
D. 510(k) Summary:
B.
C.
VITEK® 2 Streptococcus Enthromycin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK 2 Streptococcus Erythromycin 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. Erythromycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections Streptococcus pneumoniae Streptococcus pyogenes
Active in vitro but clinical significance unknown Viridans group Streptococci
The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK 2 System 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 clinically significant yeast.
1
2
The antimicrobial presented in VITEK 2 AST-ST Cards is in concentrations equivalent by efficacy to standard method concentrations in ug/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 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 Streptococcus Erythromycin 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 Streptococcus Erythromycin. 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 Streptococcus Erythromycin by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 Streptococcus Erythromycin demonstrated acceptable performance of 97.9% overall Essential Agreement and 96.7% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results using both the VITEK 2 Compact instrument svstems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an abstract image of an eagle or other bird with stylized lines representing its head and wings.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
bioMérieux, Inc. c/o Jennifer Chia-Hsuan Lin Regulatory Affairs Specialist 595 Anglum Road Hazelwood, MO 63042
FEB 1 7 2012
Re: K111976
Trade Name: VITEK®2 Streptococcus Erythromycin Regulation Number: 21 CFR §866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON Dated: January 25, 2012 Received: January 27, 2012
Dear Ms. Lin:
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 class II (Special Controls), it may be subject to such 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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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-
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Page 2 - Jennifer Chia-Hsuan Lin
- This letter will allow you to begin marketing your device as described in your Section 1000. The letter notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), 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 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,
Uhe Self 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
Enclosure
4
Indications for Use
510(k) Number (if known):__ k
Device Name: VITEK® 2 Streptococcus Erythromycin (≤0.125 - ≥8 µg/mL)
Indications For Use:
VITEK® 2 Streptococcus Erythromycin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK 2 Streptococcus Erythromycin 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. Erythromycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections Streptococcus pneumoniae Streptococcus pyogenes
Active in vitro but clinical significance unknown Viridans group Streptococci
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System 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 clinically significant yeast.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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)
Eucldia. Poole
sion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Sufety
510(k) K111976