(29 days)
Not Found
No
The summary describes a simple color-enhanced slide test for qualitative and semiquantitative detection of antibodies, with no mention of AI, ML, image processing, or any computational analysis beyond basic statistical performance metrics.
No.
The device is a diagnostic test (aids in the diagnosis of infectious mononucleosis) rather than a device designed for treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that "The test aids in the diagnosis of infectious mononucleosis," which directly indicates its diagnostic purpose.
No
The device description explicitly states it is a "slide test," which is a physical, hardware-based diagnostic method. There is no mention of software as the primary or sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma." This involves testing biological samples (serum or plasma) outside of the body to gain information about a patient's health status.
- Device Description: The description reinforces that it's a "slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma." This further confirms it's a test performed on biological samples.
- Performance Studies: The performance studies describe testing the device with "samples presumptively positive for IM heterophile antibodies" and "randomly selected serum patient samples presumptively negative for IM heterophile antibodies." This is characteristic of studies conducted for IVD devices to demonstrate their performance on patient samples.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K861016) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
82KTN
Device Description
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 97.9% (95% Confidence Interval = 88.7 - 99.9%)
Specificity: 95.8% (95% Confidence Interval = 91.9-98.2%)
Reproducibility: 100% for semiquantitative and qualitative techniques.
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.
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
§ 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).
0
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):
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
1
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
3
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
- 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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