(189 days)
Genzyme OSOM® Mono Test
Not Found
No
The device description explicitly states it is a lateral flow immunochromatographic assay that can be performed without an instrument, and there are no mentions of AI, DNN, or ML in the summary.
No
Explanation: This device is for in vitro diagnostic (IVD) use, detecting antibodies to aid in diagnosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to aid in the diagnosis of infectious Mononucleosis infection".
No
The device description clearly states it is a "lateral flow immunochromatographic assay" and a "rapid chromatographic immunoassay," which are physical test strips/devices, not software. It also mentions it can be performed "without the use of an instrument," further indicating it is not a software-only device.
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 heterophile antibodies to infectious Mononucleosis in whole blood, serum or plasma to aid in the diagnosis of infectious Mononucleosis infection". This involves testing biological samples in vitro (outside the body) to provide information for diagnosis.
- Device Description: The description details a "rapid chromatographic immunoassay" that utilizes "purified IM heterophilic antigen-coated particles and IM heterophilic antigen-coated on the membrane to selectively detect elevated levels of heterophile antibodies". This is a typical description of an in vitro diagnostic test that analyzes components of a biological sample.
- Performance Studies: The performance studies involve testing "clinical specimens including the whole blood, serum, and plasma samples" and comparing the results to a "Predicate Device". This is characteristic of the validation process for an IVD.
The core function of the device is to analyze biological samples in vitro to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of heterophile antibodies to infectious Mononucleosis in whole blood, serum or plasma to aid in the diagnosis of infectious Mononucleosis infection in adults at 18 years of age and older. They are intended for health professionals including professionals at point-of-care sites.
Product codes (comma separated list FDA assigned to the subject device)
KTN
Device Description
The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are lateral flow immunochromatographic assays for the qualitative detection of heterophile antibodies associated with infectious Mononucleosis in whole blood, serum or plasma. They utilize purified IM heterophilic antigen-coated particles and IM heterophilic antigen-coated on the membrane to selectively detect elevated levels of heterophile antibodies to infectious Mononucleosis. These tests can be performed without the use of an instrument.
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
adults at 18 years of age and older
Intended User / Care Setting
health professionals including professionals at point-of-care sites.
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 clinical evaluation was conducted using a total of 611 clinical specimens. The detection of infectious Mononucleosis specific heterophile antibodies in clinical specimens including the whole blood, serum, and plasma samples was done by using the ACON® Mononucleosis Rapid Test Strip and Test Device (Whole Blood/Serum/Plasma) and Predicate Device, Genzyme OSOM® Mono Test.
ACON® Mononucleosis Rapid Test Strip compared to Genzyme OSOM® Mono Test -Whole Blood
Positive Agreement = 49/51 = 96% (87%-99%)*
Negative Agreement = 80/80 > 99% (95%-100%)**
Overall Agreement = 129/131 = 98% (95%-99%)
ACON® Mononucleosis Rapid Test Strip compared to Genzyme OSOM® Mono Test -Plasma
Positive Agreement = 59/60 = 98% (91%-99%)*
Negative Agreement = 180/180 > 99% (98%-100%)**
Overall Agreement = 239/240 > 99% (98%-99%)*
ACON® Mononucleosis Rapid Test Strip compared to Genzyme OSOM® Mono Test -Serum
Positive Agreement = 73/73 > 99% (95%-100%)**
Negative Agreement = 167/167 > 99% (98%-100%)**
Overall Agreement = 240/240 > 99% (98%-100%)**
ACON® Mononucleosis Rapid Test Strip compared to Genzyme OSOM® Mono Test -All Specimens
Positive Agreement = 181/184 = 98% (95%-99%)*
Negative Agreement = 427/427 > 99% (99%-100%)**
Overall Agreement = 608/611 > 99% (99%-99.9%)*
ACON Mononucleosis Rapid Device compared to Genzyme OSOM® Mono Test -Whole Blood
Positive Agreement = 50/51 = 99% (90%-99%)*
Negative Agreement = 80/80 > 99% (95%-100%)**
Overall Agreement = 130/131 > 99% (96%-99%)*
ACON Mononucleosis Rapid Test Device compared to Genzyme OSOM® Mono Test -Plasma
Positive Agreement = 59/60 = 98% (91%-99%)*
Negative Agreement = 180/180 > 99% (98%-100%)**
Overall Agreement = 239/240 > 99% (98%-99%)*
ACON Mononucleosis Rapid Test Device compared to Genzyme OSOM® Mono Test -Serum
Positive Agreement = 72/73 = 99% (93%-99%)*
Negative Agreement = 167/167 > 99% (98%-100%)**
Overall Agreement = 239/240 > 99% (98%-99%)*
ACON Mononucleosis Rapid Test Device compared to Genzyme OSOM® Mono Test -All Specimens
Positive Agreement = 181/184 = 98% (95%-99%)*
Negative Agreement = 427/427 > 99% (99%-100%)**
Overall Agreement = 608/611 > 99% (99%-99.9%)*
POL Study Summary:
Utilizing a proficiency panel of coded, blinded and randomized plasma and whole blood specimens, POL studies were conducted on both types of specimens at three distinct sites. POL study results on the plasma specimens indicate that with the exception of two "false negative" results registered by one of the three POL sites, all POL study results were found to be within the expected results (178/180, 98.9%). POL study results on whole blood specimens show an overall 100% agreement (180/180) when compared to the expected results. These POL study results indicate that personnel at different doctors' offices could properly perform the ACON® Mononucleosis Rapid Test Strip and Test Device (Whole Blood/Serum/Plasma), as well as interpret the correct test results comparable to those obtained by a trained lab technician (120/120, 100%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement, Negative Agreement, Overall Agreement
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.
Genzyme 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
§ 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
FEB 2 8 2005
SUMMARY OF 510(k) 10.
This summary of safety and effectiveness information is being submitted in This Sunniary of Sarety anety anents of SMDA 1990 and 21 CFR 807.92.
The Assigned 510(k) number is K042272.
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121 Tel .: 858-535-2030 Fax: 858-535-2038
Establishment Registration Number: 2531491 Owner/Operator Number: 9063887
Date:
August 20, 2004
Contact Person:
Edward Tung, Ph.D.
Product Names:
ACON® Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma) ACON® Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma)
Common Name:
Immunochromatographic test for the qualitative detection of heterophile antibodies specific to infectious Mononucleosis.
Classification Information:
The ACON® Mononucleosis Rapid Test Strip and Test Device (Whole Blood/Serum/Plasma) are similar to other FDA-cleared devices for the qualitative detection of heterophile antibodies specific to infectious Mononucleosis.
Class II Classification: Regulation Number: 866.5640 KTN Product Code:
1
| Classification Name: | System, test, Infectious Mononucleosis |
|---|---|
| Complexity: | Moderate |
| Analyte: | Heterophile antibodies specific to infectious Mononucleosis |
| in human blood, serum or plasma | |
| Test Category: | Manual procedures with limited steps and limited sample |
| and reagent preparation |
Intended Use:
The ACON® Mononucleosis Rapid Test Strip and Test Device (Whole Blood/Serum/Plasma) are rapid chromatographic immunoassays for the qualitative detection of heterophile antibodies to infectious Mononucleosis in whole blood, serum or plasma to aid in the diagnosis of infectious Mononucleosis infection in adults at 18 years of age and older. They are intended for health professionals including professionals at point-of-care sites.
Description:
The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are lateral flow immunochromatographic assays for the qualitative detection of heterophile antibodies associated with infectious Mononucleosis in whole blood, serum or plasma. They utilize purified IM heterophilic antigen-coated particles and IM heterophilic antigen-coated on the membrane to selectively detect elevated levels of heterophile antibodies to infectious Mononucleosis. These tests can be performed without the use of an instrument.
Comparison to Predicate Devices:
A summary of comparison of the features of the ACON® Mononucleosis Rapid Test Strip, the ACON® Mononucleosis Rapid Test Device, and the predicate device is shown below:
2
| Feature | ACON® Mononucleosis
Rapid Test Strip | ACON® Mononucleosis
Rapid Test Device | Genzyme OSOM®
Mono Test |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
use | A rapid chromatographic
immunoassay for the
qualitative detection of
heterophile antibodies to
infectious Mononucleosis in
whole blood to aid in the
diagnosis of infectious
Mononucleosis infection. | A rapid chromatographic
immunoassay for the qualitative
detection of heterophile
antibodies to infectious
Mononucleosis in whole blood
to aid in the diagnosis of
infectious Mononucleosis
infection. | A lateral-flow
immunoassay intended for
the qualitative detection of
heterophile antibodies
specific to infectious
Mononucleosis in whole
blood to aid in the
diagnosis of infectious
Mononucleosis infection. |
| Intended Use | Professional | Professional | Professional |
| Intended
specimen | Whole blood, serum, plasma | Whole blood, serum, plasma | Whole blood, serum,
plasma |
| Endpoint | Colored Lines | Colored Lines | Colored Lines |
| Materials
provided | Test strips
Disposable sample test tubes
Disposable droppers
Capillary tube
Dispensing bulb
Positive control
Negative control
Buffer
Package insert
Procedure card | Test devices
Disposable droppers
Capillary tube
Dispensing bulb
Positive control
Negative control
Buffer
Package insert
Procedure card | Test devices
Disposable droppers
Capillary tube
Positive control
Negative control
Direction insert
Procedure card
Package Insert |
| Methodology | Membrane particle assay | Membrane particle assay | Membrane particle assay |
| Test Time | 5 minutes | 5 minutes | 5 minutes |
| Format | Antigen/antibody
immunoassay | Antigen/antibody immunoassay | Antigen/antibody
immunoassay |
ACON Mononucleosis Rapid Tests versus Genzyme OSOM® Mono Test Table 2.
Accuracy
A clinical evaluation was conducted using a total of 611 clinical specimens. The detection of infectious Mononucleosis specific heterophile antibodies in clinical specimens including the whole blood , serum, and plasma samples was done by using the ACON® Mononucleosis Rapid Test Strip and Test Device (Whole Blood/Serum/Plasma) and Predicate Device, Genzyme OSOM® Mono Test.
ACON® Mononucleosis Rapid Test Strip compared to Genzyme OSOM® Mono Test -Whole Blood
Positive Agreement = 49/51 = 96% (87%-99%)* Negative Agreement = 80/80 > 99% (95%-100%)** Overall Agreement = 129/131 = 98% (95%-99%) * * 95% Confidence Interval
** Since the portion can not go above 100%, this is really a 97.5% confidence interval.
3
ACON® Mononucleosis Rapid Test Strip compared to Genzyme OSOM® Mono Test -Plasma
Positive Agreement = 59/60 = 98% (91%-99%)* Negative Agreement = 180/180 > 99% (98%-100%)** Overall Agreement = 239/240 > 99% (98%-99%)* * 95% Confidence Interval
-
- Since the portion can not go above 100%, this is really a 97.5% confidence interval.
ACON® Mononucleosis Rapid Test Strip compared to Genzyme OSOM® Mono Test -Serum
Positive Agreement = 73/73 > 99% (95%-100%)** Negative Agreement = 167/167 > 99% (98%-100%)** Overall Agreement = 240/240 > 99% (98%-100%)** ** Since the portion can not go above 100%, this is really a 97.5% confidence interval.
ACON® Mononucleosis Rapid Test Strip compared to Genzyme OSOM® Mono Test -All Specimens
Positive Agreement = 181/184 = 98% (95%-99%)* Negative Agreement = 427/427 > 99% (99%-100%)** Overall Agreement = 608/61 1 > 99% (99%-99.9%)* * 95% Confidence Interval ** Since the portion can not go above 100%, this is really a 97.5% confidence interval.
ACON Mononucleosis Rapid Device compared to Genzyme OSOM® Mono Test -Whole Blood
Positive Agreement = 50/51 = 99% (90%-99%)* Negative Agreement = 80/80 > 99% (95%-100%)** Overall Agreement = 130/131 > 99% (96%-99%)* * 95% Confidence Interval ** Since the portion can not go above 100%, this is really a 97.5% confidence interval.
ACON Mononucleosis Rapid Test Device compared to Genzyme OSOM® Mono Test -Plasma
Positive Agreement = 59/60 = 98% (91%-99%)* Negative Agreement = 180/180 > 99% (98%-100%)** Overall Agreement = 239/240 > 99% (98%-99%)* * 95% Confidence Interval ** Since the portion can not go above 100%, this is really a 97.5% confidence interval.
4
ACON Mononucleosis Rapid Test Device compared to Genzyme OSOM® Mono Test -Serum
Positive Agreement = 72/73 = 99% (93%-99%)* Negative Agreement = 167/167 > 99% (98%-100%)** Overall Agreement = 239/240 > 99% (98%-99%)* * 95% Confidence Interval
** Since the portion can not go above 100%, this is really a 97.5% confidence interval.
ACON Mononucleosis Rapid Test Device compared to Genzyme OSOM® Mono Test -All Specimens
Positive Agreement = 181/184 = 98% (95%-99%)* Negative Agreement = 427/427 > 99% (99%-100%)** Overall Agreement = 608/611 > 99% (99%-99.9%)* * 95% Confidence Interval ** Since the portion can not go above 100%, this is really a 97.5% confidence interval.
POL Study Summary:
Utilizing a proficiency panel of coded, blinded and randomized plasma and whole blood specimens, POL studies were conducted on both types of specimens at three distinct sites. POL study results on the plasma specimens indicate that with the exception of two "false negative" results registered by one of the three POL sites, all POL study results were found to be within the expected results (178/180, 98.9%). POL study results on whole blood specimens show an overall 100% agreement (180/180) when compared to the expected results. These POL study results indicate that personnel at different doctors' offices could properly perform the ACON® Mononucleosis Rapid Test Strip and Test Device (Whole Blood/Serum/Plasma), as well as interpret the correct test results comparable to those obtained by a trained lab technician (120/120, 100%).
Conclusion:
Clinical and laboratory studies included in this 510(k) submission demonstrate that the ACON Mononucleosis Rapid Test Strip and Test Device (Whole Blood/ Serum/ Plasma) are substantially equivalent to the predicate device, Genzyme OSOM® Mono Test, which is already marketed in the U. S. These studies also demonstrate that these ACON Mononucleosis Rapid test products are suitable for use by the professionals including professionals at the point-of-care sites.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 8 2005
Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121
Re: K042272
K04272
Trade/Device Name: ACON Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma)
Trade/Device Name: ACON Mononucleosis Rapid Test Device (Va ACON Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma) Regulation Number: 21 CFR 866.5640 Regulation Name: Infectious Mononucleosis Immunological Test System Regulatory Class: Class II Product Code: KTN Dated: August 20, 2004 Received: August 23, 2004
Dear Dr. Tung:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your booking to (t) per is substantially equivalent (for the indications for referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce use surced in the enactment date of the Medical Device Amendments, or to devices that provision in the provisions cordance 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, the (f tee) market the device, subject to the general controls provisions of the Act. The general therefore, mainer the act include requirements for annual registration, listing of devices, good controls procession, 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 n your ac not to such additional controls. Existing major regulations affecting your device can be may of bable 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 r rease be ad noval a determination that your device complies with other requirements of the Act or that I Dri has muce a deterministered 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); an the Aut 3 requirements) ; good manufacturing practice requirements as set forth in the quality iaoening (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.
6
Page 2
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), please
ntitled, If you desire specific advice for your device on our assembly the regulation entitled,
contact the Office of Compliance at (240) 276-3084. Also, please note the Noveman contact the Office of Compliance at (240) 210-306+ 71138). You may obtain other
"Misbranding by reference to premailed notification" (21CFR Part 801.97). You may obtain of "Misbranding by reference to premainted the Act from the Division of Small
general information on your responsibilities under the Act from the Division of Small general information on your responsibilities under the rion and and and and and and and and (301) 443-6597 or at its Internet address
(301) 443-6597 or at its internet address
11 http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Robert Becker Jr.
Robert L. Becker, Jr., M.D., PhP Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
INDICATIONS FOR USE 9.
Ko42272 510(k) Number (if known):
ACON® Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma) Device Name: ACON® Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma)
Indications For Use: The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of heterophile antibodies mindhoussurys 10. " 15 " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " specific to aid in the diagnosis of infectious Mononucleosis infection in adults at 18 years of age and older. They are intended for healthcare professionals including professionals at point-of-care sites.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mana M Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) K042272