(143 days)
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No
The summary describes a latex agglutination test, a traditional laboratory method, with no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is described as a "latex agglutination test" for the identification of E.coli serogroup O157 and is not used for treatment or therapy.
Yes
The device is used for the identification of E.coli serogroup O157, which is a diagnostic function used to determine the presence of a specific pathogen.
No
The device description explicitly states it is a "latex agglutination test," which is a physical laboratory test involving reagents and a visual reaction, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the test is for the "identification of E.coli serogroup 0157 in colonies isolated from Sorbitol MacConkey (SMAC) Agar or SMAC Agar with Cefixime Tellurite Supplement." This involves testing samples derived from the human body (fecal specimens, although not directly tested, the colonies are isolated from them) in vitro (outside the body) to provide information for diagnostic purposes (identifying a specific pathogen).
- Device Description: It's a "latex agglutination test," which is a common type of assay used in IVD testing to detect the presence of specific antigens or antibodies in a sample.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description.
N/A
Intended Use / Indications for Use
The Oxoid Dryspot E.coli 0157 test is a latex agglutination test for the identification of E.coli serogroup 0157 in colonies isolated from Sorbitol MacConkey (SMAC) Agar or SMAC Agar with Cefixime Tellurite Supplement. The test is not indicated for direct testing of faccal specimens.
Product codes
GNA
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 (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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3255
Escherichia coli serological reagents.(a)
Identification. Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identifyEscherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist ofEscherichia coli antisera conjugated with a fluorescent dye used to identifyEscherichia coli directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium belonging to the genusEscherichia, and provides epidemiological information on diseases caused by this microorganism. AlthoughEscherichia coli constitutes the greater part of the microorganisms found in the intestinal tract in humans and is usually nonpathogenic, those strains which are pathogenic may cause urinary tract infections or epidemic diarrheal disease, especially in children.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
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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 consists of a stylized eagle or bird symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
FEB 2 8 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andy Hollingsworth Regulatory Affairs Manager Oxoid Limited Wade Road Basingstoke Hants RG24 8PW England
Re: K993401 Trade Name: Dryspot E. Coli 0157 Kit Regulatory Class: I Product Code: GNA Dated: December 10, 1999 Received: December 16, 1999
Dear Mr. Hollingsworth:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance 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 Manufacturers 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 Autman
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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510(K) Submission for Oxoid Dryspot E.coli 0157 kit
510(K) Number: K993401
Dryspot E.coli 0157 Kit Device Name:
Indications for Use:
The Oxoid Dryspot E.coli 0157 test is a latex agglutination test for the identification of E.coli serogroup 0157 in colonies isolated from Sorbitol MacConkey (SMAC) Agar or SMAC Agar with Cefixime Tellurite Supplement. The test is not indicated for direct testing of faccal specimens.
Wordy Dubois
Division of C 510(k) Number .
Prescription Use ....
OR
Over-the-Counter-Use .........................................................................................................................................................