(153 days)
The MONOCOL/LEX-IM TEST is a rapid color enhanced latex slide agglutination test for the qualitative and semiquantitative detection of heterophile antibodies in serum or plasma associated with infectious mononucleosis and is to be used as an aid in the diagnosis of infectious mononucleosis. This test is "For Professional Use Only".
Not Found
The provided text is an FDA 510(k) clearance letter for the MONOCOL/LEX-IM Test. While it grants market clearance, it does not contain the acceptance criteria or detailed study information required to answer your request.
Specifically, the letter states:
- "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 devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the device was cleared based on substantial equivalence to a predicate device, not necessarily on a de novo study proving it met specific performance criteria detailed in this document. The letter itself is a regulatory approval, not a scientific report of the validation study.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the clearance letter.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study is more common for imaging AI devices, and the MONOCOL/LEX-IM Test is a latex slide agglutination test.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a diagnostic test, not an AI algorithm.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not applicable, as this is a chemistry/immunology test, not an AI model.
- How the ground truth for the training set was established: Not applicable.
To obtain this information, you would need to access the full 510(k) submission document for K972457, which often contains the clinical and analytical validation studies performed by the manufacturer. The clearance letter only confirms that the FDA reviewed these materials and found the device substantially equivalent.
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DEC - 1 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
David Mycock Laboratory Director Immunostics, Inc. 3505 Sunset Avenue Ocean, NJ 07712
Re: K972457 Trade Name: MONOCOL/LEX-IM Test Regulatory Class: II Product Code: KTN Dated: June 25, 1997 Received: July 1, 1997
Dear Mr. Mycock:
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 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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Page 2
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 requlation (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, "Misbrandinq 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.qov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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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Public Health Service
DEC - 1 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
David Mycock Laboratory Director Immunostics, Inc. 3505 Sunset Avenue Ocean, NJ 07712
Re: K972457 Trade Name: MONOCOL/LEX-IM Test Regulatory Class: II Product Code: KTN Dated: June 25, 1997 Received: July 1, 1997
Dear Mr. Mycock:
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 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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Page 2
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 requlation (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, "Misbrandinq 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.qov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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/4/Picture/0 description: The image displays the text "Quality Microbiological, Serological and Immunological Reagents". The text is in a bold, sans-serif font. The text appears to be a title or heading, possibly for a document or presentation related to laboratory reagents.
K972457 510(k) Number (if known):
Device Name:_
MONOCOL/LEX-IM TEST
Indications for Use:
The MONOCOL/LEX-IM TEST is a rapid color enhanced latex slide agglutination test for the qualitative and semiquantitative detection of heterophile antibodies in serum or plasma associated with infectious mononucleosis and is to be used as an aid in the diagnosis of infectious mononucleosis. This test is "For Professional Use Only".
(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
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
Over-the-Counter Use
2.2
§ 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).