(308 days)
Not Found
Not Found
No
The description details a simple immunochromatographic assay, which is a chemical test, and there is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies.
No.
The device is a diagnostic test kit used to detect fecal occult blood for diagnostic purposes, not to treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is useful as a diagnostic test kit to aid for detection of bleeding caused by a number of gastrointestinal disorders..."
No
The device description clearly states it is an "immunochromatographic assay," which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "rapid, qualitative detection of fecal occult blood by laboratories or physicians office." This involves testing a sample (feces) outside of the body to gain diagnostic information.
- Device Description: The description confirms it's an "immunochromatographic assay," which is a common type of in vitro diagnostic test.
- Care Setting: It's intended for use in "laboratories or physicians office," which are typical settings for performing in vitro diagnostic tests.
The core function of the device is to analyze a biological sample (feces) in vitro (outside the body) to provide diagnostic information about potential gastrointestinal bleeding. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
dBest One Step Occult Blood Test Kits is a simple immunochromatographic assay for rapid, qualitative detection of fecal occult blood by laboratories or physicians office. It is useful as a diagnostic test kit to aid for detection of bleeding caused by a number of gastrointestinal disorders, such as diverticulitis, colitis, polyps and colorectal cancer. dBest One Step Occult Blood Test Kit is recommended for use in 1) Routine physical examinations, 2) Hospital monitoring for gastrointestinal bleeding and 3) Screening for colorectal cancer
Product codes
KHE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories or physicians office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using only black and white, which gives it a clean and official appearance.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR - 6 2008
Ameritek USA, Inc. c/o K.C. Yee 125 130th Street SE Everett, Washington 98208
Re: K071242
Trade/Device Name: dBest One Step Occult Blood Test Kit Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: May 1, 2007 Received: May 22, 2007
Dear K.C. Yee:
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 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); 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
1
Page 2 - Ameritek USA, Inc.
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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Robert Bradley
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indication for Use
510(k) Number (if known) K071242
Device Name: dBest One Step Occult Blood Test Kits
Indication For Use: dBest One Step Occult Blood Test Kits is a simple immunochromatographic assay for rapid, qualitative detection of fecal occult blood by laboratories or physicians office. It is useful as a diagnostic test kit to aid for detection of bleeding caused by a number of gastrointestinal disorders, such as diverticulitis, colitis, polyps and colorectal cancer. dBest One Step Occult Blood Test Kit is recommended for use in 1) Routine physical examinations, 2) Hospital monitoring for gastrointestinal bleeding and 3) Screening for colorectal cancer
X Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Josephine Bautista
Division/Sign/Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071242
Page 1 of 1