(42 days)
Not Found
No
The description focuses on optical monitoring and automated calculation based on a predetermined growth threshold, which are standard automated laboratory techniques, not indicative of AI/ML. There is no mention of AI, ML, or related terms.
No
The device is a laboratory aid for determining in vitro antimicrobial susceptibility, not for treating patients.
Yes
The device is designed for "antimicrobial susceptibility testing" and provides "MIC results" and "interpretive category result" which are used as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents". This directly supports diagnosis by identifying effective treatments for infections.
No
The device description explicitly mentions "VITEK GPS Cards" which are physical components containing antimicrobial agents and are inoculated with organism suspensions. The system also includes a "Reader/Incubator" which is hardware. While software is involved in monitoring growth and calculating results, the device is not solely software.
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 description details how the device tests isolated colonies of microorganisms outside of a living organism. It uses a miniaturized version of a standard laboratory technique (doubling dilution) to determine susceptibility.
- Function: The device analyzes biological samples (bacterial isolates) to provide information about their characteristics (susceptibility to antibiotics) that is used for diagnosis or treatment decisions.
Therefore, based on the provided information, the VITEK® Gram Positive Daptomycin device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Staphylococcus epidermidis and Stapylococcus haemolyticus. VITEK Gram Positive Daptomycin is a qualitative test. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
The VITEK® Gram Positive Susceptibility Test is intended to be used with the VITEK® System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinicant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
Product codes
LON
Device Description
VITEK® Gram Positive Daptomcyin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphyloccocus aureus, Steptococcus agalactiae, Staphylococcus epidermidis and Staphylococcous haemolyticus. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK GPS Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GPS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
After the card is inoculated with a standardized organism suspension, it is placed in the Reader/Incubator of the VITEK System. Organism growth inside the card is optically monitored throughout the 6-15 hour incubation cycle. MIC results are automatically calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.
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
An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK Gram Positive Ertapenem demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution 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 Premarket Notification (510[k]) presents data in support of VITEK Gram Positive Daptomycin. An external evaluation was designed to confirm the acceptability of VITEK Gram Positive Dapytomycin by companing its performance with the CLSI (formerly NCCLS) broth microdilution reference method. VITEK Gram Positive Daptomycin demonstrated acceptable performance of 99.5% overall Category Agreement when compared to the broth microdilution reference method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99.5% 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.”
0
NOV - 7 2005
BIOMÉRIEUX
510(k) SUMMARY
VITEK® Gram Positive Daptomycin
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenllado |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | September 23, 2005 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® Gram Positive Daptomycin (≤0.5-≥16 |
| µg/ml) | |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, | |
| 21 CFR 866.1645 | |
| Common Name: | VITEK GPS Daptomycin |
| C. Predicate Device: | VITEK Gram Positive Susceptibility (GPS) Card for |
| Linezolid (K022045) |
D. 510(k) Summary:
B
VITEK® Gram Positive Daptomcyin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphyloccocus aureus, Steptococcus agalactiae, Staphylococcus epidermidis and Staphylococcous haemolyticus. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK GPS Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GPS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
After the card is inoculated with a standardized organism suspension, it is placed in the Reader/Incubator of the VITEK System. Organism growth inside the card is optically monitored throughout the 6-15 hour incubation cycle. MIC results are automatically
bioMérieux, Inc. 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4´¯¯ http://www.biomerieux-usa.com
1
calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.
VITEK Gram Positive Ertapenem demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution 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 Premarket Notification (510[k]) presents data in support of VITEK Gram Positive Daptomycin. 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 Gram Positive Dapytomycin by companing its performance with the CLSI (formerly NCCLS) broth microdilution reference method. VITEK Gram Positive Daptomycin demonstrated acceptable performance of 99.5% overall Category Agreement when compared to the broth microdilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird symbol, represented by three curved lines forming the body and wings, with two wavy lines below suggesting movement or water.
Food and Grug Administration 2098 Gaither Road Rockville MD 20850
NOV - 7 2005
Ms. Jolyn Tenllado, RAC Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
Re: K052656
Trade/Device Name: VITEK® Gram Positive Daptomycin (≤0.5 - ≥16 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: September 23, 2005 Received: September 26, 2005
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sally a. 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
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Indications for Use
510(k) Number (if known): K05 a 656
Device Name: VITEK® Gram Positive Daptomycin (