Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma. The test aids in the diagnosis of infectious mononucleosis.

Device Description

Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma.

AI/ML Overview

This document describes the acceptance criteria and study proving the performance of the Color-Monogen device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Sensitivity
Relative to a commercially available horse red cell slide test. (No specific threshold given, but implied to be high for a diagnostic test).	97.9% (95% Confidence Interval = 88.7 - 99.9%)
Specificity
Relative to a commercially available horse red cell slide test. (No specific threshold given, but implied to be high for a diagnostic test).	95.8% (95% Confidence Interval = 91.9-98.2%)
Reproducibility (Qualitative & Semiquantitative)
100% reproducibility when accepting an error on repeated estimations of only one two-fold dilution for semiquantitative procedure, and for qualitative procedure using kit controls.	100% (Qualitative and Semiquantitative)

2. Sample Sizes and Data Provenance

Test Set Sample Sizes:
- Sensitivity: 48 samples (presumptively positive for IM heterophile antibodies)
- Specificity: 200 samples (randomly selected serum patient samples presumptively negative for IM heterophile antibodies)
- Reproducibility: An in-house IM heterophile antibody calibrator diluted from 1/1 to 1/32, plus Color-Monogen kit controls (negative and positive). The exact number of individual "samples" for reproducibility testing beyond the calibrator dilutions and controls isn't specified, but it was tested by three operators on five consecutive days.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "samples" and "serum patient samples."

3. Number of Experts and Qualifications for Ground Truth

The study design does not indicate the use of experts to establish ground truth for the test set. Instead, it uses a commercially available horse red cell slide test as the reference method for comparison to determine sensitivity and specificity.

4. Adjudication Method

No adjudication method (e.g., 2+1, 3+1, none) for the test set is described, as the ground truth was established by comparison to a predicate device, not by expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted. The study focuses on the device's performance against a predicate device, not on human reader performance with or without AI assistance.
For reproducibility, three different operators tested the samples for 5 consecutive days, but this was to assess the device's consistency, not to compare human reader performance with or without AI.

6. Standalone Performance Study

Yes, a standalone performance study was done. The reported sensitivity, specificity, and reproducibility figures represent the Color-Monogen device's performance directly, independent of human interpretation or assistance beyond following the test procedure.

7. Type of Ground Truth Used

The ground truth for sensitivity and specificity was established by comparing the Color-Monogen device's results to a commercially available horse red cell slide test. For reproducibility, an in-house IM heterophile antibody calibrator and Color-Monogen kit controls served as the reference.

8. Sample Size for the Training Set

No information is provided about a training set. This device is a diagnostic test kit (direct hemagglutination) and likely does not involve machine learning or an algorithm that requires a separate training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as no training set is mentioned or implied for this type of device.

Summary

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Section 3 Color-Monogen - 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4464 Fax:

Contact Person:

Carol Marble, Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4464

Summary Prepared:

August 28, 2001

Name of the device:

Color-Monogen

Classification name(s):

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

Identification of predicate device(s):

Sure-Vue™ Color Mono K861016

Description of the Device/Intended Use(s):

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

Color-Monogen uses the same methodology (direct hemagglutination) as the predicate Sure-Vue™ Color Mono and is substantially equivalent in performance, intended use, and safety and effectiveness.

Summary of Performance Data:

The sensitivity of Color-Monogen was qualitatively tested using 48 samples presumptively positive for IM heterophile antibodies and compared to a commercially available horse red cell slide test. The sensitivity of Color-Monogen relative to the horse red cell slide test was 97.9% (95% Confidence Interval = 88.7 - 99.9%).

The specificity of Color-Monogen was qualitatively tested using 200 randomly selected serum patient samples presumptively negative for IM heterophile antibodies. The specificity of Color-Monogen relative to the horse red cell slide test was 95.8% (95% Confidence Interval = 91.9-98.2%).

In a reproducibility study, an in-house IM heterophile antibody calibrator was diluted from 1/1 to 1/32 and tested by three different operators on 5 consecutive days following the semiquantitative procedure. The color-monogen kit controls (negative and positive) were also tested following the qualitative procedure. Accepting an error on the repeated estimations of only one two-fold dilution, the results indicated that the Color-Monogen semiquantitative and qualitative techniques gave 100% reproducibility.

KO12901

Class II

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 7 2001

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

Re: K012901

Trade/Device Name: Color-Monogen Regulation Number: 21 CFR § 866.5640 Regulation Name: Infectious Immunological Mononucleosis Test System Regulatory Class: II Product Code: KTN Dated: August 28, 2001 Received: August 29, 2001

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 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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Indications for Use Statement

Korago/ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Color-Monogen

Indications for Use:

Amed Sth

(Division Sign/Off) Division of Clinical Laboratory Devices

901 510(k) Number

(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 801.019)

OR Over-The-Counter Use

Section 2

Color-Monogen 510(k)

Page 1 of 1

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).