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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ACON® Mononucleosis Rapid Test Strip and Test Device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (ACON® Mononucleosis Rapid Test Strip)	Reported Device Performance (ACON® Mononucleosis Rapid Test Device)
Similar performance to Genzyme OSOM® Mono Test
Whole Blood:
Positive Agreement (Accuracy)	96% (87%-99% CI)	99% (90%-99% CI)
Negative Agreement (Accuracy)	> 99% (95%-100% CI)	> 99% (95%-100% CI)
Overall Agreement (Accuracy)	98% (95%-99% CI)	> 99% (96%-99% CI)
Plasma:
Positive Agreement (Accuracy)	98% (91%-99% CI)	98% (91%-99% CI)
Negative Agreement (Accuracy)	> 99% (98%-100% CI)	> 99% (98%-100% CI)
Overall Agreement (Accuracy)	> 99% (98%-99% CI)	> 99% (98%-99% CI)
Serum:
Positive Agreement (Accuracy)	> 99% (95%-100% CI)	99% (93%-99% CI)
Negative Agreement (Accuracy)	> 99% (98%-100% CI)	> 99% (98%-100% CI)
Overall Agreement (Accuracy)	> 99% (98%-100% CI)	> 99% (98%-99% CI)
All Specimens Combined:
Positive Agreement (Accuracy)	98% (95%-99% CI)	98% (95%-99% CI)
Negative Agreement (Accuracy)	> 99% (99%-100% CI)	> 99% (99%-100% CI)
Overall Agreement (Accuracy)	> 99% (99%-99.9% CI)	> 99% (99%-99.9% CI)
Point-of-Care (POL) Performance
Plasma (overall agreement with expected results)	98.9% (178/180)	Not explicitly separated, but included in overall POL results
Whole Blood (overall agreement with expected results)	100% (180/180)	Not explicitly separated, but included in overall POL results
Comparability to trained lab technician	100% (120/120)	100% (120/120)

Note: The acceptance criteria are implicitly based on the device demonstrating substantial equivalence to the predicate device (Genzyme OSOM® Mono Test). The performance metrics provided (positive agreement, negative agreement, overall agreement) are directly compared against the predicate device. The confidence intervals are provided for each agreement calculation.

Study Information

Sample sizes used for the test set and the data provenance:
- Total Test Set Sample Size (Clinical Evaluation): 611 clinical specimens (whole blood, serum, and plasma combined).
- Breakdown by specimen type:
  - Whole Blood: 131 specimens (51 positive, 80 negative)
  - Plasma: 240 specimens (60 positive, 180 negative)
  - Serum: 240 specimens (73 positive, 167 negative)
- POL Study Sample Size:
  - Plasma: 180 coded, blinded, and randomized specimens
  - Whole Blood: 180 coded, blinded, and randomized specimens
  - Comparison to trained lab technician: 120 specimens (presumably a subset read by both)
- Data Provenance: The document does not specify the country of origin of the data, nor whether it was retrospective or prospective. It only mentions "clinical specimens."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number of experts or their qualifications used to establish the "ground truth" (or reference standard) for the clinical specimens against which the ACON test and predicate test were compared.
- For the POL study, the comparison was made against "expected results" and "those obtained by a trained lab technician," implying an expert or reference method defined the true positive/negative status, but details are not provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for reconciling discrepancies in results. The study compared the ACON device directly against the Genzyme OSOM® Mono Test. Discrepancies between the two tests would contribute to the calculated agreement percentages, but no specific adjudication process for these discrepancies is mentioned.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This was not a multi-reader, multi-case (MRMC) comparative effectiveness study with AI assistance. This study evaluates the performance of a rapid diagnostic test (ACON Mononucleosis Rapid Test) against a predicate rapid diagnostic test (Genzyme OSOM® Mono Test). There is no mention of AI or human readers improving with AI assistance.
- However, a "POL Study Summary" describes evaluating the device's performance when used by personnel at "three distinct sites" (doctors' offices) and compares their results to "expected results" and "those obtained by a trained lab technician." This segment might be considered a form of multi-reader study, but it's not in the context of AI assistance. The "effect size" of improvement is not quantified, but the study showed 98.9% agreement for plasma and 100% agreement for whole blood by POL users compared to expected results, and 100% agreement compared to a trained lab technician (120/120), indicating high accuracy by non-specialized personnel.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a standalone diagnostic test (a lateral flow immunoassay) intended for human interpretation of colored lines. There is no algorithm involved in the test's result generation or interpretation in the way AI would be. The test itself is the "standalone" diagnostic.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the main accuracy study was effectively the results from the Predicate Device, Genzyme OSOM® Mono Test. This is a common approach for demonstrating substantial equivalence for rapid diagnostic tests.
- For the POL study, the ground truth was referred to as "expected results" and comparisons were made to "those obtained by a trained lab technician." This implies a reference method or expert-derived result was used to determine the true positive/negative status.
The sample size for the training set:
- The document does not mention a training set. This is a traditional immunoassay device, not a machine learning or AI-based device, so the concept of a "training set" for model development does not apply. The clinical evaluation and POL studies are performance validation studies.
How the ground truth for the training set was established:
- As there is no training set for this type of device, this question is not applicable.

Summary

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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:

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Classification Name:	System, test, Infectious Mononucleosis
Complexity:	Moderate
Analyte:	Heterophile antibodies specific to infectious Mononucleosisin human blood, serum or plasma
Test Category:	Manual procedures with limited steps and limited sampleand 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:

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:

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Feature	ACON® MononucleosisRapid Test Strip	ACON® MononucleosisRapid Test Device	Genzyme OSOM®Mono Test
Indication foruse	A rapid chromatographicimmunoassay for thequalitative detection ofheterophile antibodies toinfectious Mononucleosis inwhole blood to aid in thediagnosis of infectiousMononucleosis infection.	A rapid chromatographicimmunoassay for the qualitativedetection of heterophileantibodies to infectiousMononucleosis in whole bloodto aid in the diagnosis ofinfectious Mononucleosisinfection.	A lateral-flowimmunoassay intended forthe qualitative detection ofheterophile antibodiesspecific to infectiousMononucleosis in wholeblood to aid in thediagnosis of infectiousMononucleosis infection.
Intended Use	Professional	Professional	Professional
Intendedspecimen	Whole blood, serum, plasma	Whole blood, serum, plasma	Whole blood, serum,plasma
Endpoint	Colored Lines	Colored Lines	Colored Lines
Materialsprovided	Test stripsDisposable sample test tubesDisposable droppersCapillary tubeDispensing bulbPositive controlNegative controlBufferPackage insertProcedure card	Test devicesDisposable droppersCapillary tubeDispensing bulbPositive controlNegative controlBufferPackage insertProcedure card	Test devicesDisposable droppersCapillary tubePositive controlNegative controlDirection insertProcedure cardPackage Insert
Methodology	Membrane particle assay	Membrane particle assay	Membrane particle assay
Test Time	5 minutes	5 minutes	5 minutes
Format	Antigen/antibodyimmunoassay	Antigen/antibody immunoassay	Antigen/antibodyimmunoassay

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.

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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.

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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.

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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.

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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

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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

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).