(24 days)
No
The summary describes a traditional automated susceptibility testing system based on microdilution methodology and growth monitoring. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is a laboratory aid for antimicrobial susceptibility testing, used to determine the in vitro susceptibility of bacterial isolates to antimicrobial agents, rather than directly treating a patient.
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" to determine antimicrobial susceptibility, which is a diagnostic function. It determines the minimum inhibitory concentration (MIC), which helps in guiding treatment decisions.
No
The device description explicitly details physical components like "AST Cards," "saline," and the "VITEK 2 System" and "VITEK 2 Compact" instruments, which are hardware. The software is part of a larger system that includes hardware for processing and analysis.
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 Enterococcus species, Staphylococcus species and Streptococcus agalactiae" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates testing is performed on samples taken from the body (in vitro) to provide information for diagnosis or treatment.
- Device Description: The description details how the device works by testing bacterial isolates diluted in saline, which are then incubated and analyzed to determine the minimum inhibitory concentration (MIC) of antimicrobial agents. This process is a standard in vitro diagnostic method for determining antibiotic 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 technique. The study evaluates "Category Agreement," a metric relevant to the diagnostic interpretation of susceptibility results.
- Intended User/Care Setting: The intended user is a "laboratory aid," which aligns with the typical setting for performing in vitro diagnostic tests.
All these factors strongly indicate that the VITEK® 2 Gram Positive Vancomycin is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Positive Vancomycin is designed for antimicrobial susceptibility testing of Enterococcus species, Staphylococcus species and Streptococcus agalactiae. VITEK 2 Gram Positive Vancomycin is a quantitative 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 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 Vancomycin is designed for antimicrobial susceptibility testing of Enterococcus species. Staphylococus species and Streptococcus agalactiae. 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 mcg/mi. 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 in 0.45% 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 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 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
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 and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Vancomycin by comparing its performance with the CLSI broth microdifution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 Gram Positive Vancomvcin 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 Feb. 5, 2003. 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 Vancomvoin demonstrated acceptable performance of 99.6% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99.6% 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.
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.”
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Image /page/0/Picture/1 description: The image shows the logo for BIOMÉRIEUX. The logo consists of the company name in a stylized font below a circular graphic. A curved line extends vertically through the circle and the company name.
510(k) SUMMARY
OC, I a mili
VITEK® 2 Gram Positive Vancomycin
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenllado |
| Senior Regulatory Affairs Specialist | |
| Phone Number. | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | September 17, 2007 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Vancomycin (≤ 0.5 - ≥ 32 |
| µg/ml) | |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GP Vancomycin |
| Predicate Device: | VITEK 2 Gram Positive Daptomycin (K050075). |
D. 510(k) Summary:
B.
C.
VITEK® 2 Gram Positive Vancomycin is designed for antimicrobial susceptibility testing of Enterococcus species. Staphylococus species and Streptococcus agalactiae. 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 mcg/mi. 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 in 0.45% 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 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 antibiotic contained on the card.
VITEK 2 Gram Positive Vancomvcin demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II
1
Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003.*
The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Vancyomycin. 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 2 Gram Positive Vancomycin by comparing its performance with the CLSI broth microdifution 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 Vancomvoin demonstrated acceptable performance of 99.6% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
*Note: This device clinical trial was initiated prior to the March 5, 2007 issuance of the revised quidance, which is why the older guidance document is cited.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jolyn Tenllado Senior Regulatory Affairs Specialist bioMérieux 595 Anglum Road Hazelwood, MO 63042
OCT 1 5 2007
Re: K072668
Trade/Device Name: VITEK® 2 Gram Positive Vancomycin (≤ 0.5 - ≥ 32 µg/ml) Regulation Number: 21 CFR & 866.1645 Regulation Name: Antimicrobial Susceptibility Test System – Short Incubation Regulatory Class: II Product Code: LON Dated: September 17, 2007 Received: September 21, 2007
Dear Ms. Tenllado:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
a A
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):_____________________________________________________________________________________________________________________________________________________
Device Name: VITEK® 2 Gram Positive Vancomycin (≤ 0.5 - ≥ 32 µg/ml)
Indications For Use:
VITEK® 2 Gram Positive Vancomycin is designed for antimicrobial susceptibility testing of Enterococcus species, Staphylococcus species and Streptococcus agalactiae. VITEK 2 Gram Positive Vancomycin is a quantitative 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 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gramnegative 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)
Fuddie lu. Poole
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Asion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072668