(147 days)
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No
The summary describes an automated immunological test system for detecting fecal occult blood, with no mention of AI, ML, image processing, or related concepts.
No.
The device is an in vitro diagnostic (IVD) device used for the qualitative detection of fecal occult blood, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is intended for the qualitative detection of fecal occult blood in feces, which is used for the determination of gastrointestinal (GI) bleeding and screening for conditions like colorectal cancer. This falls under the definition of a diagnostic device as it helps identify a disease or condition.
No
The device description explicitly states it is an "immunological test system" consisting of an "Analyzer" and a "Test," indicating both hardware (Analyzer) and a physical test component (Test) are involved, not just software.
Yes, based on the provided information, this device 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).
- Device Description: The description reinforces that it's an "immunological test system intended for the qualitative detection of fecal occult blood in feces." This further confirms the in vitro nature of the test.
- Sample Type: The test is performed on "feces," which is a biological sample collected from the patient.
- Care Setting: The test is performed in "professional laboratories," which is a typical setting for IVD testing.
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. This device clearly fits this description.
N/A
Intended Use / Indications for Use
The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal (GI) disorders, e.g., colitis, polyps, and colorectal cancer.
The OC Auto Micro FOB Test is recommended for use in
- Routine physical examinations
- Monitoring for bleeding in patients
- Screening for colorectal cancer or gastrointestinal bleeding
Product codes
00X
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
gastrointestinal (GI)
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): 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
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. The profiles are rendered in a simple, graphic style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2016
Polymedco, Inc. Helen Landicho, RAC Director, Regulatory Affairs 510 Furnace Dock Road Cortlandt Manor, New York 10567
Re: K041408
Trade/Device Name: The Polymedco OC Auto Micro 80 FOB Test Regulation Number: 21 CFR § 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: 00X Dated: August 31, 2004 Received: September 1, 2004
Dear Ms. Landicho:
This letter corrects our substantially equivalent letter of October 21, 2004.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely,
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K041408
Device Name: The Polymedco OC Auto Micro 80 FOB Test
Indications For Use: The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal (GI) disorders, e.g., colitis, polyps, and colorectal cancer.
The OC Auto Micro FOB Test is recommended for use in
-
- Routine physical examinations
-
- Monitoring for bleeding in patients
-
- Screening for colorectal cancer or gastrointestinal bleeding
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evauation and Safety
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