(157 days)
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No
The summary describes an immunoassay test system for detecting fecal occult blood. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the biological and chemical aspects of the test.
No
Explanation: This device is for the qualitative detection of fecal occult blood, which is a diagnostic purpose, not a therapeutic one. It helps identify conditions like GI bleeding, colitis, polyps, and colorectal cancer, but it does not treat them.
Yes
The device is intended for the qualitative detection of fecal occult blood, which is used for the determination of gastrointestinal bleeding and for screening for colorectal cancer or gastrointestinal bleeding. These uses involve identifying a medical condition or disease.
No
The description clearly states it is an "immunoassay test system" and an "automated test," which implies the use of physical components (reagents, testing equipment) beyond just software. The intended use is for the "qualitative detection of fecal occult blood in feces," which is a laboratory process involving physical samples and analysis, not solely software processing.
Yes, based on the provided information, the "OC-Sensor DIANA iFOB Test" is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of fecal occult blood in feces." This involves testing a sample taken from the body (feces) outside of the body (in vitro) to provide diagnostic information about a patient's health (gastrointestinal bleeding).
- Sample Type: The test uses "feces," which is a biological sample taken from the patient.
- Testing Location: The test is performed by "professional laboratories," indicating it's conducted in a controlled laboratory setting, which is typical for IVD tests.
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. The OC-Sensor DIANA iFOB Test clearly fits this description.
N/A
Intended Use / Indications for Use
"OC-Sensor DIANA iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders (GI), e.g. colitis, polyps, and colorectal cancer.
The OC-Sensor DIANA iFOB test is recommended for use in:
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- Routine physical examinations
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- Monitoring bleeding in patients
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- Screening for colorectal cancer or gastrointestinal bleeding
Product codes
OOX
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
professional laboratories
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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§ 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/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Eiken Chemical Co., Ltd. c/o TUV SUD America, Inc. Mr. Stefan Preiss 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891
JAN 0 8 2010
Re: K092330
Trade/Device Name: OC-Sensor DIANA IFOB Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: OOX Dated: October 16, 2009 Received: October 19, 2009
Dear Mr. Preiss:
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 class II (Special Controls), 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
1
Page 2 - Mr. Preiss
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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,
i m cham
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name: OC-SENSOR DIANA iFOB Test
Indications for Use:
"OC-Sensor DIANA iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders (GI), e.g. colitis, polyps, and colorectal cancer.
The OC-Sensor DIANA iFOB test is recommended for use in:
-
- Routine physical examinations
-
- Monitoring bleeding in patients
-
- Screening for colorectal cancer or gastrointestinal bleeding
Prescription Use र (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) Page 1 of 1 Office of In Vitro Diagnostic Section 4.0 - Indications for Use Page 1 of 1 Device Evaluation and Safety