(31 days)
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No
The summary describes an automated susceptibility testing system for bacteria, focusing on the specific antimicrobial agents and bacterial species tested. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description points to a standard laboratory testing system.
No.
The device is intended for susceptibility testing of isolated colonies to antimicrobial agents, serving as a laboratory aid rather than directly treating a condition.
Yes
The device is intended for "susceptibility testing of isolated colonies" and "determination of in vitro susceptibility to antimicrobial agents," which are diagnostic activities.
No
The description clearly states the device is a "Susceptibility Test" intended for use with the "VITEK® System". This implies a physical test kit and a hardware system (VITEK® System) are involved, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "in vitro susceptibility testing of isolated colonies" and "in vitro susceptibility to antimicrobial agents." This clearly indicates testing performed outside of the living body, which is the definition of in vitro.
- Laboratory Aid: The intended user/care setting is described as a "laboratory aid," further supporting its use in a laboratory setting for diagnostic purposes.
Therefore, based on the provided information, the VITEK® Gram Negative Susceptibility Test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VITEK® Gram Negative 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 clinically significant aerobic gram-negative bacilli, Staphylooocus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. VITER® Gram Negative Moxifloxacin is designed for antimicrobial susceptibility testing of Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, and Proteus mirabilis. VITEK Gram Negative Moxifloxacin is for qualitative testing only. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
Product codes
LON
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
laboratory aid
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health and human services. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 4 2005
Ms. Jolyn Tenllado Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
Re: K043237
Trade/Device Name: VITEK® Gram Negative Moxifloxacin (concentrations of 2, 4, 8 µg/ml with calling range of ≤0.5 - ≥8 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: November 18, 2004 Received: November 22, 2004
Dear Ms. Tenllado:
This letter corrects our substantially equivalent letter of December 23, 2004, regarding the concentrations for the VITEK® Gram Negative Moxifloxacin (2 – 8 µg/ml) which was changed VITEK® Gram Negative intended use of the closed of 2, 4, 8 ug/ml with calling range of ≤0.5 - ≥8 ug/ml) to better reflect the intended use of the device.
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 provisions of the Anto 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 provisions of the Actuality, 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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 10gally marketed predicate device results in a classification for your device and thus, persons 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 one 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 thom of (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 Harry
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): K043237
Device Name: VITEK® Gram Negative Moxifloxacin (concentrations of 2,4,8 µg/ml with calling range of ≤ 0.5 -- ≥ 8 µg/ml)
Indications For Use:
The VITEK® Gram Negative 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 clinically significant aerobic gram-negative bacilli, Staphylooocus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. VITER® Gram Negative Moxifloxacin is designed for antimicrobial susceptibility testing of Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, and Proteus mirabilis. VITEK Gram Negative Moxifloxacin is for qualitative testing only. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K043237 the page number is 10
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