(111 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is not available to infer such technology.
No
The device is described as an aid in diagnosis and a test for occult blood, which are diagnostic purposes, not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "COLON ALERT is a rapid, convenient and non-offensive aid in the diagnosis of asymptomatic gastrointestinal conditions".
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only. The intended use describes a test for occult blood in stool, which typically involves a physical test kit, suggesting a hardware component. Without a device description, it's impossible to confirm if the device is solely software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool." This involves testing a sample (stool) in vitro (outside the body) to provide diagnostic information.
- Sample Type: The test analyzes "occult blood in the stool," which is a biological sample tested in vitro.
- Purpose: The purpose is to aid in diagnosis, which is a core function of IVD devices.
The fact that it is "FOR OVER-THE COUNTER USE" indicates its intended user and setting, but it doesn't change its classification as an IVD because it still performs an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
COLON ALERT is a rapid, convenient and non-offensive aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the asyniptomatic "gastronitestinal" ocharities" than may of the COUNTER USE". presence of occult blood in the stool. "This test is "FOR OVER-THE COUNTER USE".
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
gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter Use
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a staff with a serpent entwined around it, though it is a more abstract and modern representation.
DEC - 6 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Vincent P. LaStella Vice President Immunostics, Inc. 3505 Sunset Avenue Ocean, New Jersey 07712
K992759 Re: Trade Name: Colon Alert Test Regulatory Class: II Product Code: KHE Dated: November 15, 1999 Received: November 22, 1999
Dear Mr. LaStella:
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 (QS) 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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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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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Image /page/2/Picture/0 description: The image shows a black and white abstract design. The design features a curved shape on the left side, resembling a partial letter or an abstract form. The right side of the image contains a more angular and fragmented pattern, creating a contrast between the curved and geometric elements. The overall composition appears to be a stylized or artistic representation, possibly a logo or a graphic element.
Quality Microbiological, Serological and Immunological Reagents
510(k) Number (if known)
510(k) Number (if known): _ _ _ K992759
COLON ALERT TEST Device Name: _________________________________________________________________________________________________________________________________________________________________
i
Indications for Use:
COLON ALERT is a rapid, convenient and non-offensive aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the asyniptomatic "gastronitestinal" ocharities" than may of the COUNTER USE".
presence of occult blood in the stool. "This test is "FOR OVER-THE COUNTER USE".
(PLEASE DO NOT WRITE BELOW THIS LINE-GONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
|--|--|
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K993959 |
| Prescription Use | ✓ | OR | Over-the-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
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