The OSOM® Mono Test is intended for the qualitative detection of infectious monomucleosis heterophile antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis.

Device Description

The OSOM Mono Test uses color immunochromatographic dipstick technology with bovine erythrocyte extract coated on the membrane. In the test procedure, serum, plasma or whole blood is mixed with the Diluent. Then the Test Stick is placed in the mixture migrates along the membrane. If the specific IM heterophile antibody is present in the sample, it will form a complex with the bovine erythrocyte extract conjugated color particles. The complex will then be bound by bovine erythrocyte xtract immobilized on the membrane and a visible blue Test Line will appear to indicate a positive result.

AI/ML Overview

The Sekisui Diagnostics OSOM Mono Test is a qualitative diagnostic device for infectious mononucleosis heterophile antibodies. The 510(k) submission [K181436] focuses on a device modification: replacing the prior capillary tube with the Microsafe capillary pipette for whole blood collection.

Here's an analysis of the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

Modification / Test Performed	Acceptance Criteria	Reported Device Performance
Replacement of Capillary Pipette
Volume Capability Study	Average volume within and across lots between 50µL and 55µL (-0% - +10%)	Met acceptance criteria. The average volume across and within lots of Microsafe pipettes was between 50uL and 55 uL.
Compatibility Study	All tests should exhibit a negative result	Met acceptance criteria. All patients had negative results. (Implies the new pipette did not introduce false positives or interfere with negative samples).
Time to dispense	For Information only (No specific acceptance criterion, as it was for informational purposes)	No adverse effects on dispensing at 30, 60, and 120 seconds. (Suggests consistent and timely delivery of sample without performance degradation due to dispensing time variability).

2. Sample Size Used for the Test Set and Data Provenance

The document provides limited detail on sample sizes for the "Compatibility Study". It states "All patients had negative results." The exact number of patients is not specified.

Data provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective for the non-clinical tests. Given the nature of a device modification focused on a component change, these tests are typically conducted in-house by the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies described are non-clinical, focusing on the functionality of the new pipette, rather than clinical efficacy studies requiring expert interpretation of results.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the studies were non-clinical performance tests of a component, an adjudication method typically used for clinical interpretation of diagnostic results would not be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical evaluation of a device component modification. The focus was not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device, OSOM Mono Test, is an immunochromatographic dipstick test for heterophile antibodies, not an AI algorithm. The studies focused on the physical characteristics and compatibility of a new pipette component.

7. The Type of Ground Truth Used

Volume Capability Study: The ground truth for this study was the actual dispensed volume measured by a calibrated method, compared against the target range of 50µL and 55µL.
Compatibility Study: The ground truth for this study was the known negative status of the patient samples, allowing the assessment of whether the new pipette introduced false positive reactions or interfered with negative results.

8. The Sample Size for the Training Set

This is not applicable. The OSOM Mono Test is a rapid diagnostic test based on immunochromatographic principles, not a machine learning algorithm that requires a training set. The "device modification" refers to a physical component (pipette), not an algorithmic change.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for this type of device and modification.

Summary

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June 22, 2018

Sekisui Diagnostics, LLC Shelly Harris Director Regulatory Affairs 6659 Top Gun Street San Diego, California 92121

Re: K181436

Trade/Device Name: OSOM Mono Test Regulation Number: 21 CFR 866.5640 Regulation Name: Infectious mononucleosis immunological test system Regulatory Class: Class II Product Code: KTN Dated: May 31, 2018 Received: June 1, 2018

Dear Shelly Harris:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tamara V. Feldblyum -S for

Uwe Scherf, Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181436

Device Name OSOM Mono Test

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Sekisui Diagnostics. The logo features the company name in a bold, blue sans-serif font, with a red dot in the letter 'C'. Below the company name, the word 'DIAGNOSTICS' is written in a smaller, black sans-serif font. The tagline 'Because every result matters' is written in a smaller, italicized font below the word 'DIAGNOSTICS'.

510(k) Summary

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21CFR §807.92(c). This is a Special 510(k): Device Modification.

SPONSOR/APPLICANT INFORMATION AND DATE [807.92(A)(1)]

Manufacturer's Address: Sekisui Diagnostics, LLC 6659 Top Gun Street San Diego, CA 92121 Registration Number: 2030538 FEI Number: 1000520007

Submission Contact Person: Marian Gerdes

Date Summary prepared: June 21,2018

DEVICE NAME AND CLASSIFICATION [807.92 (A) (2)]

Trade Name: OSOM Mono Test

Common Name: Infectious Mononucleosis test Classification Name: Infectious mononucleosis immunological test system (21CFR 866.5640) Class: 2 Product Code: KTN

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

IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICES [807.92(A)(3)]

Sekisui Diagnostics OSOM Mono Test, K972231

DESCRIPTION OF DEVICE [807.92 (A)(4)]

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Image /page/4/Picture/0 description: The image shows the logo for Sekisui Diagnostics. The logo is blue and features the company name in a bold, sans-serif font. A red dot is present in the upper left corner of the 'S' in Sekisui and also in the word 'Diagnostics'. Below the company name is the tagline "Because every result matters" in a smaller, italicized font.

PHYSIOLOGIC BASIS OF THE TEST:

The diagnosis of infectious mononucleosis (IM) is suggested, on the basis of the clinical symptoms of fever, sore throat and swollen lymph glands. The highest incidence of symptomatic IM occurs during late adolescence (15-24 years of age). Infectious mononucleosis is caused by the Epstein-Barr Virus (EBV). The laboratory diagnosis of IM is based on the detection of IM heterophile antibodies. These heterophile antibodies are directed against antigens found in bovine, sheep and horse erythrocytes. The OSOM Mono Test utilizes an extract of bovine erythrocytes to give the required sensitivity and specificity.

DEVICE MODIFICATION:

The proposed device modification will replace the current capillary tube, which includes a Mylar wrapped glass tube and a dry natural rubber latex bulb, with the Microsafe capillary pipette. The Microsafe Tube is a one-piece, single-use device designed for the collecting and dispensing of micro samples of whole blood, at the point of care.

	Proposed:	Predicate:SD OSOM Mono Test, K972231
	SD OSOM Mono Test
Intended Use	Same	The OSOM® Mono Test is intended forthe qualitative detection of infectiousmononucleosis heterophile antibodies inserum, plasma or whole blood as an aidin the diagnosis of infectiousmononucleosis.
Qualitative	Same	Yes
Read Results	Same	5 minutes
Test Principle	Same	Immunochromatographic Device
Format	Same	Lateral Flow
Antibodies Used	Same	Bovine erythrocyte extract
Specimen Types	Same	Serum, Plasma and whole blood
Fingertip wholeblood collectiondevice	Microsafe is a one-piece single useplastic capillary pipette	Capillary Tubes (Mylar wrapped glasstubes) with 1 Capillary Bulb (contains drynatural rubber)
Sample Volume	Same	50 - 55uL
Read Result Time	Same	5 minutes
External Controls	Same	Mono Positive and Negative Controlsprovided in the kitInternal procedural control
Labeling - IFU	Proposed:Kit Contents and storage:25 Capillary PipettesNote: Extra components (tubes,pipettes, capillary pipettes) have beenprovided foryour convenience.	Predicate:Kit Contents and storage:25 Capillary Tubes with 1 Capillary BulbNote: Extra components (tubes, pipettes,capillary tubes, capillary bulb) have beenprovided for your convenience.
	Proposed:	Predicate:
	SD OSOM Mono Test	SD OSOM Mono Test, K972231
	WARNINGS AND PRECAUTIONSFor hazards and precautions, refer tothe safety data sheet.• Caution: Federal Law restricts sale ofthis device to or on the order of alicensedpractitioner.• For in-vitro diagnostic use only.• Follow your laboratory safetyguidelines in the collection, handling,storageand disposal of patient specimens andall items exposed to patient specimens.• The Diluent and Controls containsodium azide which may react with leador copper plumbing to form potentiallyexplosive metal azide. For sitespermitted to dispose of material down asink: large quantities of water must beused to flushdiscarded control material down a sink.• Do not interchange or mix componentsfrom different kit lots.	WARNINGS AND PRECAUTIONSWarningH317: May cause an allergic skin reaction.P280: Wear protective gloves/protectiveclothing/eye protection/faceprotection.• For in-vitro diagnostic use only.• Follow your laboratory safety guidelinesin the collection, handling, storageand disposal of patient specimens and allitems exposed to patient specimens.• The Diluent and Controls contain sodiumazide which may react with lead or copperplumbing to form potentially explosivemetal azide. For sites permitted to disposeof material down a sink: large quantities ofwater must be used to flushdiscarded control material down a sink.• The Capillary Bulb contains dry naturalrubber.• Do not interchange or mix componentsfrom different kit lots.
Picture of	Specimen Collection andPreparation:Fingertip Whole BloodHold the capillary pipette horizontally,and touch the tip of thepipette to the drop of blood on thepatient's finger until it fills completely.Note: Filling is automatic; never squeezethe pipette bulb while collecting sample.	Specimen Collection and Preparation:Fingertip Whole BloodHold the capillary tube horizontally whilecollecting the sample. Holding the capillarytube near the red circle, touch the otherend of the capillary tube to the drop ofblood on the patient's finger. Fill thecapillary tube completely. Place the smallend of the black bulb onto the capillarytube. Place your fingertip over the openingin the bulb. Squeeze the bulb to dispensethe whole blood sample into the test tube.
micropipette	Image: micropipette	Image: micropipette

TECHNOLOGICAL SIMILARITIES AND DIFFERENCES TO THE PREDICATE [807.92 (A){G)]

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Image /page/5/Picture/0 description: The image shows the logo for Sekisui Diagnostics. The logo features the word "SEKISUI" in large, bold blue letters, with a red dot in the middle of the "I". Below "SEKISUI" is the word "DIAGNOSTICS" in smaller, black letters. Underneath that is the tagline "Because every result matters" in a smaller, italicized font.

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Image /page/6/Picture/0 description: The image shows the logo for Sekisui Diagnostics. The logo features the word "SEKISUI" in large, bold, blue letters, with a red dot in the middle of the "S". Below "SEKISUI" is the word "DIAGNOSTICS" in smaller, black letters, with a red dot in the middle of the "O". Underneath the logo is the tagline "Because every result matters" in a smaller, italicized font.

MMARY OF NON-CLINICAL PERFORMANCE DATA [807.92 (B)(I)]

Modification	Test Performed	Acceptance Criteria	Testing Results
Replacement ofCapillary Pipette	Volume CapabilityStudy	Average volume withinand across lots between$50\muL$ and $55\muL$ (-0% -+10%)	Met acceptancecriteria.The average volumeacross and within lotsof Microsafe pipetteswas between 50uL and55 uL.
	Compatibility Study	All tests should exhibit anegative result	Met acceptancecriteria. All patientshad negative results.
	Time to dispense	For Information only	No adverse effects ondispensing at 30, 60and 120 seconds.

All non-clinical performance data meets the acceptance criteria. The volume dispensed was consistently within the tolerance limit and there were no compatibility issues, all samples testing was negative as expected supporting the substantial equivalence decision.

SUMMARY OF CLINICAL PERFORMANCE EVALUATION

The scientific principles of the device remain unchanged and the modification to the device do not impact the performance characteristics of the assay;therefore, additional clinical performance evaluation was not deemed necessary per the FMEA results.

CONCLUSION

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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).