(201 days)
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Not Found
No
The summary describes a simple in-vitro guaiac slide test, which is a chemical reaction-based assay, and there are no mentions of AI, ML, image processing, or any related concepts.
No
The device is an in-vitro diagnostic test kit used for detection, not treatment, of a condition.
Yes
The device is used for the qualitative detection of human occult blood in feces, which is described as a "useful aid for detection of bleeding caused by a number of gastrointestinal disorders." This clearly indicates its use in diagnosing medical conditions.
No
The device is described as an "in-vitro guaiac slide test assay," which is a physical test kit involving chemical reactions on a slide, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "dBest Sensitive Occult Blood Test Kit is a simple in-vitro guaiac slide test assay for the rapid, qualitative detection of human occult blood in feces..."
The term "in-vitro" directly indicates that the test is performed outside of the living body, which is the defining characteristic of an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
dBest Sensitive Occult Blood Test Kit is a simple in-vitro guaiac slide test assay for the rapid, qualitative detection of human occult blood in feces, as a useful aid for detection of bleeding caused by a number of gastrointestinal disorders. The dBest Sensitive Occult Blood Test Kit is for clinical situations and professional laboratory 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
clinical situations and professional laboratory use
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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§ 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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 1 1999
AmeriTek, Inc. C/O K.C. Yee. M.D., Ph.D. President and CEO 7030 35th Avenue, N.E. Seattle, Washington 98115
K984269 Re:
Trade Name: AmeriTek dBest Sensitive Occult Blood Test Kit Regulatory Class: II Product Code: KHE Dated: February 14, 1999 Received: February 22, 1999
Dear Dr. Yee:
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 Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 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 Gutman
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
2
of Page
510 (K) Number (if known): K 984269
Device Name: dBest Sensitive Occult Blood Test Kit
Indications For Use:
dBest Sensitive Occult Blood Test Kit is a simple in-vitro guaiac slide test assay for the rapid, qualitative detection of human occult blood in feces, as a useful aid for detection of bleeding caused by a number of gastrointestinal disorders. The dBest Sensitive Occult Blood Test Kit is for clinical situations and professional laboratory use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PATE IF NEEDEN)
Peter E. Mafem
Laboratory Devic
Prescription Use V
OR
Over-The -Counter Use (Optional Format 1-2-96)