(21 days)
Not Found
No
The device description details a traditional immunochromatographic assay based on chemical reactions and visual interpretation, with no mention of AI/ML terms or processes.
No
The device aids in the diagnosis of infectious mononucleosis by detecting antibodies, but it does not treat or cure the condition, which is the definition of a therapeutic device.
Yes
The document explicitly states in the "Intended Use / Indications for Use" section that the device is intended "as an aid in the diagnosis of infectious mononucleosis."
No
The device description clearly outlines a physical test kit utilizing immunochromatographic dipstick technology and chemical reagents (bovine erythrocyte extract, diluent). This involves hardware components and chemical processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of infectious monomucleosis heterophile antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis." This clearly indicates the device is used to test samples taken from the body (in vitro) to provide information for diagnosis.
- Device Description: The description details how the device interacts with biological samples (serum, plasma, whole blood) to detect specific antibodies. This is a hallmark of an in vitro diagnostic test.
- Predicate Device: The predicate device listed (K972231; Sekisui Diagnostics OSOM Mono Test) is also an IVD, further confirming the nature of this device.
The information provided strongly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OSOM® Mono Test is intended for the qualitative detection of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis.
Product codes
KTN
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.
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.
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
The highest incidence of symptomatic IM occurs during late adolescence (15-24 years of age).
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)
Non-clinical performance data was submitted, including a Volume Capability Study, Compatibility Study, and Time to dispense study after a device modification. All non-clinical performance data met 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.
No additional clinical performance evaluation was deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K181436
Device Name OSOM Mono Test
Indications for Use (Describe)
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.
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)]
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.
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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 for
the qualitative detection of infectious
mononucleosis heterophile antibodies in
serum, plasma or whole blood as an aid
in the diagnosis of infectious
mononucleosis. | |
| 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 whole
blood collection
device | Microsafe is a one-piece single use
plastic capillary pipette | Capillary Tubes (Mylar wrapped glass
tubes) with 1 Capillary Bulb (contains dry
natural rubber) | |
| Sample Volume | Same | 50 - 55uL | |
| Read Result Time | Same | 5 minutes | |
| External Controls | Same | Mono Positive and Negative Controls
provided in the kit
Internal procedural control | |
| Labeling - IFU | Proposed:
Kit Contents and storage:
25 Capillary Pipettes
Note: Extra components (tubes,
pipettes, capillary pipettes) have been
provided for
your convenience. | Predicate:
Kit Contents and storage:
25 Capillary Tubes with 1 Capillary Bulb
Note: Extra components (tubes, pipettes,
capillary tubes, capillary bulb) have been
provided for your convenience. | |
| | Proposed: | Predicate: | |
| | SD OSOM Mono Test | SD OSOM Mono Test, K972231 | |
| | WARNINGS AND PRECAUTIONS
For hazards and precautions, refer to
the safety data sheet.
• Caution: Federal Law restricts sale of
this device to or on the order of a
licensed
practitioner.
• For in-vitro diagnostic use only.
• Follow your laboratory safety
guidelines in the collection, handling,
storage
and disposal of patient specimens and
all items exposed to patient specimens.
• The Diluent and Controls contain
sodium azide which may react with lead
or copper plumbing to form potentially
explosive metal azide. For sites
permitted to dispose of material down a
sink: large quantities of water must be
used to flush
discarded control material down a sink.
• Do not interchange or mix components
from different kit lots. | WARNINGS AND PRECAUTIONS
Warning
H317: May cause an allergic skin reaction.
P280: Wear protective gloves/protective
clothing/eye protection/face
protection.
• For in-vitro diagnostic use only.
• Follow your laboratory safety guidelines
in the collection, handling, storage
and disposal of patient specimens and all
items exposed to patient specimens.
• The Diluent and Controls contain sodium
azide which may react with lead or copper
plumbing to form potentially explosive
metal azide. For sites permitted to dispose
of material down a sink: large quantities of
water must be used to flush
discarded control material down a sink.
• The Capillary Bulb contains dry natural
rubber.
• Do not interchange or mix components
from different kit lots. | |
| Picture of | Specimen Collection and
Preparation:
Fingertip Whole Blood
Hold the capillary pipette horizontally,
and touch the tip of the
pipette to the drop of blood on the
patient's finger until it fills completely.
Note: Filling is automatic; never squeeze
the pipette bulb while collecting sample. | Specimen Collection and Preparation:
Fingertip Whole Blood
Hold the capillary tube horizontally while
collecting the sample. Holding the capillary
tube near the red circle, touch the other
end of the capillary tube to the drop of
blood on the patient's finger. Fill the
capillary tube completely. Place the small
end of the black bulb onto the capillary
tube. Place your fingertip over the opening
in the bulb. Squeeze the bulb to dispense
the 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 of | |||
| Capillary Pipette | Volume Capability | ||
| Study | Average volume within | ||
| and across lots between | |||
| $50\muL$ and $55\muL$ (-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. | |||
| Time to dispense | For Information only | No adverse effects on | |
| dispensing at 30, 60 | |||
| and 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.