(41 days)
N50510/S113
No
The description focuses on automated microdilution techniques and growth monitoring, with no mention of AI/ML algorithms for analysis or interpretation.
No
This device is a laboratory aid for determining in vitro susceptibility to antimicrobial agents, not a therapeutic device. It helps predict mecA-mediated resistance and performs susceptibility testing on isolated colonies, which is a diagnostic function, not a treatment.
Yes
The device is a qualitative test and an Antimicrobial Susceptibility Test (AST) intended for use as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," which directly relates to diagnosing and guiding treatment for infections.
No
The device description clearly outlines physical components like AST cards, a VITEK 2 system (which fills, seals, and incubates the cards), and a manual filling/sealing operation for the VITEK 2 Compact. This indicates a hardware component is integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "qualitative test designed to predict mecAmediated resistance in staphylococci" and is intended for use "as 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 information about a patient's condition (susceptibility to antibiotics).
- Device Description: The description details how the device tests bacterial isolates in vitro using a miniaturized microdilution methodology.
- Intended User / Care Setting: It is intended for use as a "laboratory aid," which is a typical setting for IVD devices.
The information provided strongly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Positive Cefoxitin Screen is a qualitative test designed to predict mecAmediated resistance in staphylococci. 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.
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 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 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 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. For the VITEK 2 Cefoxitin Screen the report will list either a positive or negative test 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
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 Cefoxitin Screen by comparing its performance with the CLSI disk diffinsion test. 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 file, K050002.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 Cefoxitin Screen demonstrated substantially equivalent performance when compared with the CLSI reference method, disk diffusion test for prediction of mecA-mediated resistance in staphylococci.
VITEK 2 Gram Positive Cefoxitin Screen demonstrated acceptable performance of 97.2% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
97.2% 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.
VITEK 2 Gram Positive AST for High-Level Streptomycin (N50510/S113)
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/0 description: The image shows a document with the date DEC 14 2005 at the top left. Below the date is the word BIOMERIEUX, which appears to be a company name. There is a black circle to the right of the date and above the company name. The text is in a simple, sans-serif font.
510(k) SUMMARY
VITEK® 2 Gram Positive Cefoxitin Screen
510(k) Submission 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: | October 31, 2005 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Cefoxitin Screen |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, 21 CFR 866.1645 | |
| Common Name: | VITEK 2 Cefoxitin Screen (OXSF) |
| Predicate Device: | VITEK 2 Gram Positive AST for High-Level Streptomycin |
| (N50510/S113) |
D. 510(k) Summary:
в.
C.
VITEK® 2 Gram Positive Cefoxitin Screen is a qualitative test designed to predict mecA-mediated resistance in staphylococoi. 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 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 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 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. For the VITEK 2 Cefoxitin Screen the report will list either a positive or negative test result.
VITEK 2 Cefoxitin Screen demonstrated substantially equivalent performance when compared with the CLSI reference method, disk diffusion test for prediction of mecA-mediated resistance in staphylococci.
1
The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Cefoxitin Screen. 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 Cefoxitin Screen by comparing its performance with the CLSI disk diffinsion test. 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 file, K050002. VITEK 2 Gram Positive Cefoxitin Screen demonstrated acceptable performance of 97.2% overall Category Agreement. 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 image of three abstract human figures or birds, stacked on top of each other, with their heads facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 4 2005
Ms. Nancy Weaver Staff Regulatory Affairs Specialist bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
K053097 Trade/Device Name: VITEK® 2 Gram Positive Cefoxitin Screen (6 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: October 31, 2005 Received: November 3, 2005
Dear Ms. Weaver:
Re:
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 Hogg
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): J 053 09 7
Device Name: VITEK® 2 Gram Positive Cefoxitin Screen (6 µg/ml)
Indications For Use:
VITEK® 2 Gram Positive Cefoxitin Screen is a qualitative test designed to predict mecAmediated resistance in staphylococci. 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)
Fendate A. Poole
Division Sign-Off
ision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
KOS 3097 510(k)_ Page 1 of 1