K Number

Device Name

BIORAPID MONONUCLEOSIS

Manufacturer

INSTRUMENTATION LABORATORY CO.

Date Cleared

2003-02-24

(34 days)

Product Code

KTN

Regulation Number

866.5640

Intended Use

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K972231

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a simple immunoassay (immunochromatography test) and does not mention any AI/ML components or image processing. The performance studies focus on agreement with a predicate device and reproducibility, not on the performance of an algorithm.

Therapeutic

The device is an immunoassay for the qualitative detection of mononucleosis antibodies, aiding in diagnosis, not providing therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that "The test aids in the diagnosis of infectious mononucleosis."

SaMD (Software as a Medical Device)

The device description clearly states it is an "immunoassay" and uses "immunochromatography test," which are hardware-based laboratory methods for detecting substances. It also mentions testing "whole blood, serum, and plasma samples," which requires physical handling and analysis of biological specimens.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the "qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples." This involves testing biological samples taken from the body.
Aids in Diagnosis: The intended use also states the test "aids in the diagnosis of infectious mononucleosis." This is a key characteristic of IVD devices, as they provide information used to help diagnose medical conditions.
Device Description: The description confirms it's an "immunoassay" and uses "immunochromatography," which are common techniques used in IVD tests to detect specific substances in biological samples.
Sample Types: The test is performed on "whole blood, serum, and plasma samples," which are biological specimens.
Performance Studies: The performance studies involve evaluating the device using "specimens" (biological samples).

All of these points align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

KTN

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

positive agreement of 100% and a negative agreement of 99.6% (478/480). The overall agreement between the two tests was 99.7%.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K972231 OSOM Mono Test

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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:

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.

Page 2 -

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

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 _