(71 days)
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No
The summary provides no indication of AI/ML technology. It describes a standard microbiological testing panel.
No
The device aids in detecting specific bacteria strains, which is a diagnostic function, not a therapeutic one that treats or prevents disease.
Yes
The device is used to detect specific bacterial strains, which is a diagnostic function.
No
The device description clearly states "MicroScan® Dried Gram Negative MIC/Combo Panels Cefpodoxime (0.015-64 ug/ml)", which describes a physical laboratory panel, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "detect Escherichia coli, Klebsiella oxytoca, and K. pneumoniae strains suspected of harboring suspected extended spectrum betalactamase enzymes." This clearly indicates the device is used to perform tests on samples taken from the human body (in this case, likely bacterial cultures derived from patient samples) to provide information about a disease state or condition (the presence of specific bacteria and their resistance mechanisms).
- Device Description: The description "MicroScan® Dried Gram Negative MIC/Combo Panels Cefpodoxime" describes a laboratory test panel used to determine the minimum inhibitory concentration (MIC) of an antibiotic (Cefpodoxime) against specific bacteria. This is a standard method used in clinical microbiology laboratories to guide antibiotic treatment, which is a core function of IVDs.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
To detect Escherichia coli, Klebsiella oxytoca, and K. pneumoniae strains suspected of harboring suspected extended spectrum betalactamase enzymcs.
Product codes
JWY, LRG
Device Description
MicroScan® Dried Gram Negative MIC/Combo Panels Cefpodoxime (0.015-64 ug/ml)
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 (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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing the body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Cynthia Van Duker Manager, Regulatory Affairs Dade Behring 1584 Enterprise Boulevard West Sacramento, CA 95691
DEC 1 2 2001
Re: K013423
Trade/Device Name: MicroScan® Dried Gram Negative MIC/Combo Panels Cefpodoxime (0.015-64 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: September 28, 2001 Received: October 2, 2001
Dear Ms. Van Duker:
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 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 510(k) premarket I his lower will and in your your dine of substantial equivalence of your device to a legally marketed noutheation. The I Dr I intellig sification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 II you desire specific an vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 594-1566. Fraunce at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionitation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Intended Use Statcment
510(k) No.:
K013423
IDevice Name:
MicroScan® Dried Gram Negative MIC/Combo Panels Cefpodoxime (0.015-64 µg/ml)
Indications for Use:
To detect Escherichia coli, Klebsiella oxytoca, and K. pneumoniae strains suspected of harboring suspected extended spectrum betalactamase enzymcs.
Freddie Poole
(Division Sign-Off) Division of Clinical Laboratory Devices
101 3423 510(k) Number_
Prescription Use Device -