COLOR-MONOGEN

K012901 · Instrumentation Laboratory CO · KTN · Sep 27, 2001 · Immunology

Device Facts

• Record ID: K012901
• Device Name: COLOR-MONOGEN
• Applicant: Instrumentation Laboratory CO
• Product Code: KTN · Immunology
• Decision Date: Sep 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5640
• Device Class: Class 2

Intended Use

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 Story

Color-Monogen is a color-enhanced slide test for detecting infectious mononucleosis heterophile antibodies. Input samples consist of serum or EDTA plasma. The device utilizes direct hemagglutination to identify antibodies; results are visualized via color enhancement on a slide. The test is performed by laboratory personnel to provide qualitative or semiquantitative results. Healthcare providers use these results to aid in the clinical diagnosis of infectious mononucleosis.

Clinical Evidence

Bench testing only. Sensitivity was 97.9% (95% CI: 88.7-99.9%) based on 48 positive samples compared to a commercial horse red cell slide test. Specificity was 95.8% (95% CI: 91.9-98.2%) based on 200 negative samples. Reproducibility study using serial dilutions (1/1 to 1/32) across three operators over five days demonstrated 100% reproducibility, allowing for a one two-fold dilution error margin.

Technological Characteristics

Direct hemagglutination assay; color-enhanced slide test format. Designed for qualitative and semiquantitative detection of heterophile antibodies in serum or EDTA plasma. No electronic components, software, or external energy sources required.

Indications for Use

Indicated for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma to aid in the diagnosis of infectious mononucleosis.

Regulatory Classification

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.

Predicate Devices

• Sure-Vue™ Color Mono (K861016)

Submission Summary (Full Text)

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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: [phone] Fax:

#### Contact Person:

Carol Marble, Regulatory Affairs Manager Phone: [phone] / Fax: [phone]

### 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):

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.

# 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

Amed Sth

(Division Sign/Off) Division of Clinical Laboratory Devices

012. 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)

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