(190 days)
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None
No
The summary describes a qualitative immunoassay for detecting antibodies, which is a standard laboratory technique and does not mention any AI/ML components or image processing.
No
The device aids in diagnosis by detecting antibodies but does not directly treat or prevent a disease.
Yes
Explanation: The device is an immunoassay for the qualitative detection of antibodies as an aid in the diagnosis of infectious mononucleosis, which directly indicates a diagnostic purpose.
No
The provided text describes an immunoassay, which is a laboratory test involving biological reagents and physical components, not a software-only device. The lack of information about software in the description further supports this conclusion.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "immunoassay for the qualitative detection of Infectious Mononucleosis lgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis." This clearly describes a test performed in vitro (outside the body) on human specimens (serum or plasma) to provide information for diagnostic purposes.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The description of Clearview IM perfectly aligns with this definition.
N/A
Intended Use / Indications for Use
Clearview IM is an immunoassay for the qualitative detection of Infectious Mononucleosis lgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis.
Product codes
KTN
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
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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.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5640 Infectious mononucleosis immunological test system.
(a)
Identification. An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three human profiles in the negative space of the eagle's body.
DEC 1 0 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Louise Roberts Requlatory Affairs Manager Unipath Limited Bedford, MK44 3UP UNITED KINGDOM
Re: K981946 Clearview™ IM Trade Name: Requlatory Class: II Product Code: KTN Dated: June 1, 1998 Received: June 3, 1998
Dear Ms. Roberts:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral controls provisions of the Act include requirements for annual reqistration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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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 diaqnostic 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Gutman
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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510(k) Number (if known): K981946
Clearview re IM Device Name:
Indications For Use:
Clearview IM is an immunoassay for the qualitative detection of Infectious Mononucleosis lgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis.
Tita E. Mafere
Division Sign-Off
Division of Clinical 510(k) Numb
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Countor Use_
(Optional Format 1-2-96)
O