(387 days)
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No
The 510(k) summary describes a simple immunoassay for detecting fecal occult blood and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is an in vitro diagnostic test used for the detection of fecal occult blood, which aids in diagnosing gastrointestinal disorders. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is for the "qualitative detection of fecal occult blood... useful to determine gastrointestinal bleeding found in gastrointestinal disorders." This clearly indicates its role in diagnosing a medical condition.
No
The 510(k) summary describes a physical in vitro diagnostic test kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For professional in vitro diagnostic use only." This is a clear indication that the device is intended for use in diagnosing conditions outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician's offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders. For professional in vitro diagnostic use only.
Product codes
KHE
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
laboratories or physician's offices.
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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Date: December 19, 2012
IND Diagnostics Inc. C/O Kai Ming Lou 1629 Fosters Way Delta, B.C. V3M 6S7 Canada
Re: K113506
Trade/Device Name: IND One Step Fecal Occult Blood Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Codes: KHE
Dated: November 20, 2012 Received: November 21, 2012
Dear Mr. Lou:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip -S
for
Maria M. Chan, Ph.D.
Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_k113506
Device Name: IND One Step Fecal Occult Blood (FOB) Test
Indications For Use:
The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician's offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders.
For professional in vitro diagnostic use only.
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 Diagnostics and Radiological Health (OIR)
Mon
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510k K113506
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