(90 days)
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No
The summary describes a traditional immunological test for detecting fecal occult blood and contains no mention of AI, ML, or related concepts like image processing or training/test sets.
No
The device is an in vitro diagnostic test used to detect fecal occult blood, which aids in the determination of gastrointestinal bleeding and screening for colorectal cancer. It identifies a condition but does not treat, prevent, or cure disease.
Yes
The device is intended for the detection of fecal occult blood to determine gastrointestinal bleeding, which is a diagnostic purpose.
No
The device description clearly states it is an "immunological test intended for the detection of fecal occult blood in feces," which implies a physical test kit or reagent, not purely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "immunological test intended for the detection of fecal occult blood in feces." This involves testing a sample (feces) taken from the body in vitro (outside the body) to diagnose or provide information about a medical condition (gastrointestinal bleeding, potential colorectal cancer).
- Device Description: The device description reinforces that it's an "immunological test intended for the detection of fecal occult blood in feces," again highlighting the in vitro nature of the testing.
- Care Setting: The intended users are "professional laboratories and physician office labs," which are typical settings for performing in vitro diagnostic tests.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The Polymedco OC Light FOB test is an immunological test intended for the detection of fecal occult blood in feces by professional laboratories and physician office labs. The test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of test is useral for the disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer.
The OC Light test is recommended for use in
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- routine physical examinations
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- monitoring for bleeding in patients
-
- screening for colorectal cancer or gastrointestinal bleeding
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
professional laboratories and physician office labs
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a simple, official representation of the department.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 2 2004
Ms. Helen Landicho, RAC I)irector of Regulatory Affairs Polymedco Inc. 510 Furnace Dock Rd. Cortlandt Manor, NY 10567
Re: K041297
Trade/Device Name: The Polymedco OC Light FOB Test Regulation Number: 21 CFR 866.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: June 30, 2004 Received: July 9, 2004
Dear Ms. Landicho:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the energe, 1976, the enactment date of the Medical Device Amendments, or to commerce province have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that have been that do not require approval of a premarket approval application (PMA). and Cosmetic Act (110) market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of gencial controls proficturing 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 n may be buoject to back 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 r touse be actived a determination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any Feathall 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 OFF Part 807), as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter rections as over 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert L. Becker Jr.
Robert I.. Becker, Jr., M.D., 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
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SECTION 12.0 INDICATIONS FOR USE STATEMENT
Ke41297 510(k) Number: -
Device Name: The Polymedco OC Light FOB Test
Indications For Use:
The Polymedco OC Light FOB test is an immunological test intended for the detection of fecal occult blood in feces by professional laboratories and physician office labs. The test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of test is useral for the disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer.
The OC Light test is recommended for use in
-
- routine physical examinations
-
- monitoring for bleeding in patients
-
- screening for colorectal cancer or gastrointestinal bleeding
(PLEASE NO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
A.P. Reeve for S. Bautista
ision of Clinical Laboratory Devices
KO41997 510(k) Number -
V Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
Polymedco, Inc.