(184 days)
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.
The provided document is an FDA 510(k) clearance letter for the DRYSPOT® Infectious Mononucleosis Kit and its Indications for Use. This type of document, particularly for an in vitro diagnostic (IVD) kit like this one, does not typically contain the detailed information necessary to answer all parts of your request about acceptance criteria and a study proving device performance in the context of, for example, an AI medical device.
The information you've requested pertains more to performance evaluation studies for complex medical devices, especially those utilizing AI, which involves measuring diagnostic accuracy against a ground truth established by experts.
However, I can extract what is implicitly present or can be inferred, and clearly state what is missing based on the provided text.
Here's an attempt to answer your questions based only on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the format you've requested. For IVD devices like this one cleared via 510(k), performance is typically demonstrated against a predicate device and/or clinical samples, but the specific metrics are not in this letter.
The "Indications for Use" section describes the device's mechanism:
- "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." (Positive result)
- "Agglutination will not occur when such an antibody is absent." (Negative result)
Implicit Performance Criteria (Inferential, not explicit in the document):
- Sensitivity: Should be high enough to detect the heterophile antibody when present (i.e., agglutination occurs).
- Specificity: Should be high enough to not show agglutination when the antibody is absent.
- Time to Result: Agglutination should occur within 2 minutes.
Reported Device Performance:
The document does not provide specific performance metrics such as sensitivity, specificity, accuracy, positive predictive value (PPV), or negative predictive value (NPV) for the DRYSPOT® Infectious Mononucleosis Kit. It only describes the mechanism of action.
2. Sample size used for the test set and the data provenance
The document does not mention the sample size used for any test set or the provenance of any data. This information would typically be in a detailed study report submitted with the 510(k), but it is not part of this clearance letter or the "Indications for Use" statement.
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 text. For an IVD like this, ground truth would typically be established by clinical diagnosis, potentially supported by other laboratory assays, but the specifics of how it was established for the study are not detailed here. The concept of "experts" in the context of adjudicating AI output (e.g., radiologists) is not applicable here as this is a chemical/latex agglutination test, not an image-based AI device.
4. Adjudication method for the test set
This information is not present in the provided text. Adjudication methods like "2+1" or "3+1" are characteristic of studies involving human interpretation (e.g., reading medical images) where multiple readers might disagree, and a tie-breaker or consensus is needed. For a latex agglutination test, the result (agglutination or no agglutination) is generally intended to be objectively observable, though inter-reader variability could still exist but is not typically addressed with a formal adjudication process described in this manner.
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
- No, an MRMC comparative effectiveness study was not done, nor is it applicable. The DRYSPOT® Infectious Mononucleosis Kit is an in vitro diagnostic device that directly detects an antibody in blood samples. It is not an AI-powered device, nor is it designed to assist human readers in interpreting complex data (like medical images). Therefore, the concept of "human readers improving with AI assistance" does not apply to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The DRYSPOT® Infectious Mononucleosis Kit is a physical diagnostic test kit, not an algorithm. Its performance is inherent to the chemical and biological interaction designed, not an algorithmic output.
7. The type of ground truth used
The document does not explicitly state the type of ground truth used for performance evaluation. However, given it's an assay for "specific heterophile antibody associated with IM," the ground truth would most likely be established through:
- Clinical diagnosis of Infectious Mononucleosis (IM): Integrating patient symptoms, physical examination findings, and potentially other confirmatory lab tests (e.g., complete blood count with atypical lymphocytes, Epstein-Barr virus (EBV) serology if the etiology is being confirmed).
- Other laboratory assays: More definitive or reference IM tests (e.g., various EBV antibody tests, or established predicate IM tests) could have been used to define true positive/negative samples for the study.
8. The sample size for the training set
The document does not mention any training set or its sample size. This concept is most relevant for machine learning/AI devices, which this IVD kit is not.
9. How the ground truth for the training set was established
- Not applicable. As the device is not an AI algorithm, there is no "training set" in the machine learning sense, and thus no ground truth established for such a set.
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Public Health Service
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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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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
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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 .........................................................................................................................................................
§ 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).