biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis. biorapid Mononucleosis uses the same methodology (immunochromatography test) as the predicate OSOM Mono Test.

AI/ML Overview

The provided text describes the performance of the biorapid Mononucleosis device. There are no explicit "acceptance criteria" presented as specific numerical thresholds that the device must meet in relation to a given ground truth. Instead, the study compares the device's performance against a legally marketed predicate device (OSOM Mono Test) to demonstrate substantial equivalence.

Here's an breakdown based on the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" (e.g., "The device must achieve >95% sensitivity") are not stated. The performance is reported relative to the predicate device.

Metric	Acceptance Criteria (Not explicitly stated, but implied by "substantially equivalent" to predicate)	Reported Device Performance (biorapid Mononucleosis vs. OSOM Mono Test)
Positive Agreement (between biorapid and predicate)	Implied to be high, demonstrating similar ability to detect positive cases.	100%
Negative Agreement (between biorapid and predicate)	Implied to be high, demonstrating similar ability to detect negative cases.	99.6% (478/480)
Overall Agreement (between biorapid and predicate)	Implied to be high, demonstrating overall similar performance.	99.7%
Reproducibility	100% agreement with expected results in reproducibility study.	100% agreement with expected results

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: A total of 622 specimens.
- 296 serum samples
- 261 plasma samples
- 65 whole blood samples
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It only mentions that the specimens "were evaluated internally and in an external study."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. The study uses the OSOM Mono Test (predicate device) as the comparator, implying that the "ground truth" for the performance comparison is the result obtained by the predicate device, not an independent expert consensus or clinical outcome.

4. Adjudication Method for the Test Set

This information is not provided. Given that the comparison is device-to-device rather than device-to-expert ground truth, a formal adjudication method as typically used with human readers is not applicable in the context described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described in the provided text in the context of human readers improving with or without AI assistance. The study focuses on comparing the new device's performance to a predicate device, not on human reader performance.

6. If a Standalone Study Was Done (Algorithm only without human-in-the-loop performance)

Yes, the performance reported is a standalone evaluation of the biorapid Mononucleosis device compared to the predicate device. The results (positive agreement, negative agreement, overall agreement) reflect the device's intrinsic performance. The reproducibility study also evaluates the device's standalone performance under different user conditions.

7. The Type of Ground Truth Used

The "ground truth" for the primary performance evaluation (agreement study) was the results obtained from the predicate device (OSOM Mono Test). This is a common approach in 510(k) submissions for in vitro diagnostics where substantial equivalence is demonstrated by comparing performance to a legally marketed device.

For the reproducibility study, the "expected results" were used as the ground truth for the three positive and three negative samples. This implies that these samples had a predetermined positive or negative status.

8. The Sample Size for the Training Set

This information is not provided. The document focuses on the performance evaluation of the final device and does not detail any development or training phases. For an immunoassay, the concept of a "training set" in the context of machine learning (AI) is not typically applicable in the same way.

9. How the Ground Truth for the Training Set Was Established

This information is not provided, as details about a training set or its ground truth establishment are not mentioned in the context of this immunoassay.

Summary

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FEB 2 4 2003

330215

biorapid Mononucleosis - 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207

Contact Person:

Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207

Summary Prepared:

January 17, 2003

Name of the device:

biorapid Mononucleosis

Classification name(s):

866.5640	Infectious Mononucleosis Immunological Test System	Class
82KTN	System, Test, Infectious Mononucleosis

Identification of predicate device(s):

K972231 OSOM Mono Test

Description of the Device/Intended Use(s):

Statement of Technological Characteristics of the Device Compared to Predicate Device:

biorapid Mononucleosis uses the same methodology (immunochromatography test) as the predicate OSOM Mono Test and is substantially equivalent in performance, intended use and safety and effectiveness.

Summary of Performance Data:

A total of 622 specimens (296 serum, 261 plasma, and 65 whole blood) were evaluated internally and in an external study with biorapid Mononucleosis and the predicate device, OSOM Mono Test. When compared to the predicate device, biorapid Mononucleosis showed a positive agreement of 100% and a negative agreement of 99.6% (478/480). The overall agreement between the two tests was 99.7%.

A reproducibility evaluation of the biorapid Mononucleosis test was conducted at three physician's offices laboratories (POL's) where testing was performed by personnel with diverse educational backgrounds. At each site, randomly coded samples (three positive and three negative) were tested in triplicate for three days. Results obtained showed a 100% agreement with the expected results.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads in profile, facing to the left. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle.

FEB 2 4 2003

Food and Drug Administration i 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421

Re: K030215

Trade/Device Name: biorapid Mononucleosis Regulation Number: 21 CFR § 866.5640 Regulation Name: Infectious Mononucleosis Immunological Test System Regulatory Class: II Product Code: KTN Dated: January 17, 2003 Received: January 21, 2003

Dear Ms. Marble:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K030215

Device Name: biorapid Mononucleosis

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

J. Plewes for J. Bautista

Clinical Laboratory D Diveron J. 510(K) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use
(Per 21 CFR 801.019)

OR Over-The-Counter Use _

Regulation Number and Section

§ 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).