(184 days)
Not Found
Not Found
No
The device description details a simple latex agglutination test based on a chemical reaction, with no mention of AI or ML.
No
The device is described as an "assay" and a "test" intended for the "rapid diagnosis of IM" by detecting an antibody. It does not treat or prevent any medical condition.
Yes
The device is described as "an aid in the rapid diagnosis of IM," and it detects a specific antibody associated with the disease, indicating its use for diagnostic purposes.
No
The device description clearly states it is a "latex agglutination test" which involves physical components (latex particles, serum/plasma) and a chemical reaction (agglutination), indicating it is a hardware-based diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for use as an aid in the rapid diagnosis of infectious mononucleosis (IM). This is a diagnostic purpose.
- Device Description: The device performs a test on biological samples (serum and plasma) to detect a specific substance (heterophile antibody) associated with a disease (IM). This is the core function of an in vitro diagnostic device.
- Mechanism: The test involves mixing the patient sample with reagents (latex particles coated with antigen) outside of the body to observe a reaction (agglutination) that indicates the presence of the target substance. This is the definition of an in vitro test.
The information provided clearly indicates that this device is used to perform a diagnostic test on a biological sample outside of the body to aid in the diagnosis of a medical condition. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Acute infectious mononucleoisis is a self-limiting clinical syndrome that most commonly occurs in teenagers and young adults in developed nations. In developing, IM can occur much earlier in life. This assay is intended for use as an aid in the rapid diagnosis of IM.
The Dryspot IM Test is a simple two minute latex agglutination test for the detection of the specific heterophile antibody associated with IM in serum and plasma. The purified specific heterophile antigen from bovine red cell membranes is used to coat latex particles. When a drop of serum or plasma containing the heterophile antibody associated with IM is mixed with a drop of latex, visible agglutination of the latex occurs within 2 minutes. Agglutination will not occur when such an antibody is absent.
A final diagnosis of IM, however, should only be made when clinical and haematological findings as well as the results from the Dryspot IM Test have been taken into consideration.
Product codes
KTN
Device Description
The Dryspot IM Test is a simple two minute latex agglutination test for the detection of the specific heterophile antibody associated with IM in serum and plasma. The purified specific heterophile antigen from bovine red cell membranes is used to coat latex particles. When a drop of serum or plasma containing the heterophile antibody associated with IM is mixed with a drop of latex, visible agglutination of the latex occurs within 2 minutes. Agglutination will not occur when such an antibody is absent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
teenagers and young adults in developed nations. In developing, IM can occur much earlier in life.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the figure, emphasizing the department's role within the United States.
JAN 28 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andy Hollingsworth Regulatory Affairs Manager Oxoid Limited Wade Road Basingstoke Hants RG24 8PW ENGLAND
Re: K982634
Trade Name: DRYSPOT® Infectious Mononucleosis Kit Regulatory Class: II Product Code: KTN Dated: December 21, 1998 Received: December 28, 1998
Dear Mr. Hollingsworth:
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, 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 regulation (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. "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 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
2
510(K) Submission for Oxoid
Dryspot Infectious Mononucleosis Kit
510(K) Number: K982634
Dryspot Infectious Mononucleosis Kit Device Name:
Indications for Use:
Acute infectious mononucleoisis is a self-limiting clinical syndrome that most commonly occurs in teenagers and young adults in developed nations. In developing, IM can occur much earlier in life. This assay is intended for use as an aid in the rapid diagnosis of IM.
The Dryspot IM Test is a simple two minute latex agglutination test for the detection of the specific heterophile antibody associated with IM in serum and plasma. The purified specific heterophile antigen from bovine red cell membranes is used to coat latex particles. When a drop of serum or plasma containing the heterophile antibody associated with IM is mixed with a drop of latex, visible agglutination of the latex occurs within 2 minutes. Agglutination will not occur when such an antibody is absent.
A final diagnosis of IM, however, should only be made when clinical and haematological findings as well as the results from the Dryspot IM Test have been taken into consideration.
Tua E. Maler'
(Division Sign-Off)
Division of Clinical Laboratory Devices K087634
510(k) Number
Prescription Use.....!........................................................................................................................................................
Over-the-Counter-Use .........................................................................................................................................................