(104 days)
The Hema-Screen™ Specific is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.
Not Found
This is an FDA 510(k) clearance letter for the hema-screen™ SPECIFIC Immunochemical Fecal Occult Blood Test (FOBT) with DEVEL-A-TAB Sampler. While it confirms the device is substantially equivalent to a predicate device, it does not contain the detailed study information typically found in a clinical study report or a 510(k) summary (which might be a separate document). Therefore, I cannot provide all the requested information.
Based on the provided document, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The document is a clearance letter, not a performance study report.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not present in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present in the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present in the provided document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is an immunochemical fecal occult blood test, which is a diagnostic kit, not an AI-powered image analysis system that would typically involve human readers interpreting results. Therefore, an MRMC study with human readers improving with AI assistance would not be applicable to this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Given this is a diagnostic test kit and not an algorithm, the concept of "standalone algorithm performance" as it applies to AI/software devices is not directly applicable. The performance would be based on the biochemical reaction and detection method of the kit itself. The document does not provide performance data for the kit.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not present in the provided document. For a fecal occult blood test, ground truth would typically be established through colonoscopy/pathology results to confirm the presence or absence of GI bleeding or specific conditions like colorectal cancer.
8. The sample size for the training set:
This information is not present in the provided document. This device is not an AI/machine learning model that typically requires a "training set."
9. How the ground truth for the training set was established:
This information is not present in the provided document. As mentioned, the concept of a "training set" for an AI/ML model is not applicable here.
Summary of available information from the document:
- Device Name: hema-screen™ SPECIFIC Immunochemical Fecal Occult Blood Test (FOBT) with DEVEL-A-TAB Sampler
- Intended Use: Rapid and qualitative determination of Human Blood in fecal samples. Intended for professional and laboratory use only. Useful for determining gastrointestinal bleeding due to GI disorders (diverticulitis, colitis, polyps, colorectal cancer). Recommended for routine physical exams, hospital monitoring of bleeding, and screening for colorectal cancer or GI bleeding.
- Regulatory Class: Class II
- Predicate Device: The substantial equivalence determination is based on a comparison to legally marketed predicate devices, but specific details of those predicate devices or the comparison are not provided in this letter.
To obtain the detailed study information, one would typically need to review the 510(k) Summary that Immunostics, Inc. submitted to the FDA, which often contains abstracts of the performance studies. This clearance letter only confirms the FDA's decision, not the full dataset or methodology.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
JUN -6 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Immunostics, Inc. c/o Mr. Jeffrey Fleishman Manager, Regulatory Affairs 3505 Sunset Ave. Ocean, NJ 07712
Re: K060463
Trade/Device Name: hema-screen™ SPECIFIC Immunochemical Fecal Occult Blood Test (FOBT) with DEVEL-A-TAB Sampler
Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: KHE Dated: February 21, 2006 Received: February 22, 2006
Dear Mr. Fleishman:
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 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 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 Part 801); 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.
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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 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 Compliance at (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Marie Chan for
Dr. Robert Becker
Robert L. 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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Indication of Use Statement
K060463 510(k) Number (if known):
Device Name:
Hema-Screen™ Specific
Indications for Use:
The Hema-Screen™ Specific is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.
Prescription Use (Part 21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert H. Becker
Division Sign-Off
Office of In Vitro Diagnostic Device
2004(k) K060463
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3505 Sunset Avenue, Ocean, New Jersey 07712 · 732-918-0770 · FAX 732-918-0618
§ 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.