(56 days)
N50510/S110
Not Found
No
The description focuses on standard microbiological techniques and automated reading of growth, with no mention of AI or ML algorithms for interpretation or analysis beyond basic growth detection and MIC calculation.
No.
The device is a laboratory aid for determining in vitro susceptibility to antimicrobial agents, not for directly treating a condition.
Yes
The device aids in determining in vitro susceptibility to antimicrobial agents, providing an MIC value and interpretive category result, which are diagnostic information for guiding treatment.
No
The device description clearly outlines a physical card (VITEK 2 AST Cards) and a system (VITEK 2 System) that handles, incubates, and reads these cards. This involves significant hardware components beyond just software.
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" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates it is used to test samples in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details how the device works by testing bacterial isolates in a laboratory setting using a microdilution methodology. This is a standard technique for in vitro diagnostic testing.
- Performance Studies: The performance studies compare the device's performance to a "microbroth dilution reference method," which is a common reference standard for in vitro diagnostic tests. The metric used, "Essential Agreement," is also a typical measure of performance for antimicrobial susceptibility testing.
- Predicate Device: The predicate device listed is also a "Susceptibility Test," further reinforcing that this type of device falls under the category of in vitro diagnostics.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Positive Linezolid is designed for antimicrobial susceptibility testing of Enterococcus faecalis, E. faecium, Staphylococcus aureus, S. epidermidis, S. haemolyticus and Streptococcus agalactiae. It is intended for use with the VITEK® 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
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 versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) my 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 automatically fills, seals and places the card into the incubator/reader. 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 Linezolid by comparing its performance with the NCCLS microbroth dilution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 Gram Positive Linezolid demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; guidance for Industry and FDA. Issued February 5, 2003.
VITEK 2 Gram Positive Linezolid demonstrated acceptable performance of 98.7% overall Essential Agreement when compared to the microbroth dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
98.7% overall Essential 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.
VITEK® 2 Gram Positive Susceptibility Test for Norfloxacin (N50510/S110)
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.
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
OCT 3 1 2003
Image /page/0/Picture/2 description: The image shows the logo for bioMérieux. The logo consists of a circle that is half black and half white with horizontal lines. Below the circle is the word "BIOMÉRIEUX" in a sans-serif font.
510(k) SUMMARY
VITEK® 2 Gram Positive Linezolid
A. Submitter Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Nancy Weaver |
| Staff Regulatory Affairs Specialist | |
| Phone Number: | (314) 731-8695 |
| Fax Number: | (314) 731-8689 |
| Date of Preparation: | September 3, 2003 |
B. Device Name:
| Formal/Trade Name: | VITEK® 2 Gram Positive Linezolid (0.5 - 2.0 µg/ml) |
|---|---|
| Classification Name: | Fully Automated Short-Term Incubation Cycle Antimicrobial |
| Susceptibility Device, 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GP Linezolid |
| Predicate Device: | VITEK® 2 Gram Positive Susceptibility Test for Norfloxacin |
| (N50510/S110) |
D. 510(k) Summary:
C.
VITEK® 2 Gram Positive Linezolid is designed for antimicrobial susceptibility testing of Enterococcus faecalis, E. faecium, Staphylooocus aureus, S. epidermidis, S. haemolyticus and Streptococus agalactiae. It is intended for use with the VITEK 2 System 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 versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) my 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 automatically fills, seals and places the card into the incubator/reader. 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 Linezolid demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; guidance for Industry and FDA. Issued February 5, 2003.
1
The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Quinupristin/ dalfopristin. 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 Linezolid by comparing its performance with the NCCLS microbroth dilution reference method. VITEK 2 Gram Positive Linezolid demonstrated acceptable performance of 98.7% overall Essential Agreement when compared to the microbroth dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe. The figure is composed of three curved lines, and the globe is represented by a series of concentric circles.
OCT 3 1 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Weaver Staff Regulatory Affairs Specialist BioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
K032766 Re:
Trade/Device Name: VITEK 2® Gram Positive Linezolid (0.5-2.0 ug/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 3, 2003 Received: September 5, 2003
Dear Ms. Weaver:
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): KO327bb
Device Name: VITEK® 2 Gram Positive Linezolid (0.5 – 2.0 µg/ml)
Indications for Use:
VITEK® 2 Gram Positive Linezolid is designed for antimicrobial susceptibility testing of Enterococcus faecalis, E. faecium, Staphylococcus aureus, S. epidermidis, S. haemolyticus and Streptococcus agalactiae. It is intended for use with the VITEK® 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Luddi h. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032764
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