(65 days)
Not Found
No
The description focuses on automated quantitative/qualitative susceptibility testing using a miniaturized doubling dilution technique and monitoring growth over time. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," which means it helps identify which antibiotics are effective against specific bacteria, rather than directly treating a patient.
Yes
The device aids in the determination of in vitro susceptibility to antimicrobial agents for Streptococcus species, providing MIC values and interpretive categorical results. This information is used for diagnostic purposes to guide antimicrobial treatment.
No
The device description clearly outlines physical components (AST Cards, VITEK® 2 and VITEK® 2 Compact Systems) and a physical process (diluting, filling, sealing, incubating, reading growth). This indicates it is a hardware-based system with associated software, 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 of Streptococcus species" and 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 description details how the device tests isolated colonies of microorganisms, which is a common practice in in vitro diagnostic testing.
- Performance Studies: The performance studies compare the device's performance to a "CLSI broth microdilution reference method," which is a standard method for in vitro susceptibility testing.
- Predicate Device: The predicate device listed (VITEK® 2 Gram Positive Amoxicillin for Streptococcus pneumoniae) is also an IVD, indicating that this type of device falls under the IVD category.
The device is used to test samples (isolated colonies of bacteria) outside of the human body to provide information about the susceptibility of those bacteria to antimicrobial agents, which is a classic definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Streptococcus Linezolid is designed for antimicrobial susceptibility testing of Streptococcus species 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 Streptococcus Linezolid is a qualitative test. Linezolid 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 agalactiae Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSP]) Streptococcus pyogenes
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 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 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 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
laboratory aid
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-ST Linezolid by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hrs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-ST Linezolid demonstrated substantially equivalent performance 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-ST Linezolid. 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-ST Linezolid 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 AST-ST Linezolid demonstrated acceptable performance of 99.8% overall essential Agreement and 99.8% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99.8% overall essential Agreement and 99.8% overall category agreement.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of a circle that is split in half, with one half having vertical lines and the other half being solid black. The text "BIOMERIEUX" is written below the circle in a stylized font.
AUG 1 2 2011
510(k) SUMMARY
VITEK® 2 AST-ST Linezolid
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. | |
|---|---|---|
| Address: | 595 Anglum Road | |
| Hazelwood, MO 63042 | ||
| Contact Person: | Nathan Hardesty | |
| Senior Regulatory Affairs Specialist | ||
| Phone Number: | 314-731-8666 | |
| Fax Number: | 314-731-8689 | |
| Date of Preparation: | April 15, 2011 | |
| B. | Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-ST Linezolid | |
| Classification Name: | 21 CFR 866.1645 | |
| Fully Automated Short-Term Incubation Cycle | ||
| Antimicrobial Susceptibility System | ||
| Product Code LON | ||
| Common Name: | VITEK® 2 AST-ST Linezolid | |
| C. | Predicate Device: | |
| VITEK® 2 Gram Positive Amoxicillin for Streptococcus | ||
| pneumoniae (K063597) |
D. 510(k) Summary:
B.
C.
VITEK® 2 Streptococcus Linezolid is designed for antimicrobial susceptibility testing of Streptococcus species 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 Streptococcus Linezolid is a qualitative test. Linezolid 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 agalactiae Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSP]) Streptococcus pvogenes
The antimicrobial presented in VITEK® 2 AST-ST 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.
bioMérieux, Inc.
595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700 http://www.biomerieux-usa.com
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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 AST-ST Linezolid demonstrated substantially equivalent performance 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-ST Linezolid. 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-ST Linezolid 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 AST-ST Linezolid demonstrated acceptable performance of 99.8% overall essential Agreement and 99.8% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
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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. U.S." arranged around the perimeter. Inside the circle is an abstract symbol of a stylized eagle or bird with its wings spread, representing the department's mission related to health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
BioMerieux Inc. c/o Nathan Hardesty Senior Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042-2320
AUG 12 2011
Re: K111599
Trade/Device Name: VITEK® 2 AST-ST Linezolid Regulation Number: 21 CFR§ 866.1645 Regulation Name: VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LON Dated: June 3. 2011 Received: June 8, 2011
Dear Mr. Hardesty:
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 10 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 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 of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
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Page 2 - Nathan Hardesty
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 Parts 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 vours,
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
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Indications for Use
510(k) Number (if known):
Device Name: VITEK® 2 AST-ST Linezolid ( ≤ 2 − ≥ 8 µg/mL )
Indications For Use:
VITEK® 2 Streptococcus Linezolid is designed for antimicrobial susceptibility testing of Streptococcus species 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 Streptococcus Linezolid is a qualitative test. Linezolid 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 agalactiae Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSP]) Streptococcus pyogenes
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 clinically significant yeast.
Prescription Use X (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)
Freddie W. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K111599
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