(28 days)
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No
The summary describes a blood culture system and related components for microbial detection and susceptibility testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
No
The device is used for cultivating, recovering, identifying, and performing susceptibility testing of microorganisms, not for direct treatment or diagnosis of a condition.
Yes
The device aids in the cultivation, recovery, and identification of microorganisms (bacteria, yeasts, mycobacteria) from body fluids, and also performs susceptibility testing for Mycobacterium tuberculosis, all of which are diagnostic processes.
No
The device description is not provided, but the intended use and predicate devices clearly describe a "Blood Culture System" and "Culture system II" which are hardware instruments used for cultivating and recovering microorganisms. The software components mentioned (e.g., for organism identification and susceptibility testing) appear to be part of or used in conjunction with these hardware systems, not a standalone software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses clearly describe the device being used to examine specimens (blood, body fluids, clinical specimens) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
- Specific Examples:
- Blood Culture System: Cultivating and recovering microorganisms from blood and body fluids is a classic example of an in vitro diagnostic test.
- Myco Detection: Culturing and recovering mycobacteria from specimens is also an in vitro diagnostic procedure.
- Organism Identification: Using nucleic acid probes to identify organisms is an in vitro diagnostic method.
- Susceptibility Testing: Testing the susceptibility of Mycobacterium tuberculosis to drugs in vitro is a crucial part of diagnosing and guiding treatment for tuberculosis.
All of these activities fall under the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for clinical purposes.
N/A
Intended Use / Indications for Use
VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids. VersaTREK Myco, with VersaTrek Myco GS, and Either VersaTREK as or PVNA added is a selective growth medium for use with either VersaTREK or ESP II Culture system II for the culture recovery of mycobacteria from sterile body specimens and from digested-decontaminated clinical specimens. Organism identification may be determined using nucleic acid probes (AccuProbe®). The VersaTREK Myco Susceptibility Kit is intended for qualitative in vitro susceptibility testing of isolated colonies of Mycobacterium tuberculosis with Rifampin, Ethambutol, and Isoniazid on the VersaTREK instrument. Appropriate inoculum sources are prepared from growth on solid agar, such as Middlebrook 7H10 or Lowenstein-Jensen slants, or Middlebrook 7H9 broth.
Product codes
MDB
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
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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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.2560 Microbial growth monitor.
(a)
Identification. A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
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Image /page/0/Picture/1 description: The image shows a stylized drawing of an eagle or bird in flight. The bird is composed of thick, black lines that create a sense of movement and dynamism. The bird is surrounded by a dotted circle, which adds a sense of enclosure and focus to the image.
Public Health Service
AUG 2 2 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Nadine M. Sullivan, Ph.D. Chief Science Officer TREK Diagnostic Systems 982 Keynote Circle, Suite 6 Cleveland, OH 44131
Re: K032306
Trade/Device Name: VERSATREK Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: July 17, 2003 Received: July 25, 2003
Dear Dr. Sullivan:
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 Putman
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 VersaTREK Instrument
Blood Culture System (K921637/A): VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.
Myco Detection (K972756): VersaTREK Myco, with VersaTrek Myco GS, and Either VersaTREK as or PVNA added is a selective growth medium for use with either VersaTREK or ESP II Culture system II for the culture recovery of mycobacteria from sterile body specimens and from digested-decontaminated clinical specimens.
Myco modification-Organism Identification (KK972772): Organism identification may be determined using nucleic acid probes (AccuProbe®) .
Mvcobacterium tuberculosis susceptibility testing (K972772): The VersaTREK Myco Susceptibility Kit is intended for qualitative in vitro susceptibility testing of isolated colonies of Mycobacterium tuberculosis with Rifampin, Ethambutol, and Isoniazid on the VersaTREK instrument. Appropriate inoculum sources are prepared from growth on solid agar, such as Middlebrook 7H10 or Lowenstein-Jensen slants, or Middlebrook 7H9 broth.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Salafanos 8/20/03
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Ko32306
Prescription Use (Per 21CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)