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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.

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 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

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.

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The OSOM™ Mono Test is intended for the qualitative determination of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aids in the diagnosis of infectious mononucleosis .

OSOM Mono Test uses color immunochromatographic technology with bovine erythrocyte extract coated on the membrane. If the specific IM heterophile antibody is present in the sample, a visible blue test line will appear to indicate a positive result.

The provided text is a 510(k) summary for the OSOM™ Mono Test, an in vitro diagnostic device. It does not contain the detailed study information or acceptance criteria requested in the prompt.

Specifically, the document focuses on:

• Device Identification: Proprietary name, common name, classification.
• Intended Use: Qualitative determination of infectious mononucleosis heterophile antibodies.
• Description: Color immunochromatographic technology.
• Substantial Equivalence Claim: Comparing it to two predicate devices (Meridian's MonoSpot Latex Test and Pacific Biotech's CARDS OS Mono Test) based on similar intended use and technology.
• Regulatory Communication: An FDA letter granting substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, ground truth information, or details about MRMC or standalone studies because this information is not present in the provided text.

The document implies that the device meets criteria for substantial equivalence to predicates, but it does not specify what those criteria are or present the data from a study to demonstrate performance against such criteria. The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, which means its performance is considered comparable enough, but the specific data supporting that comparison is not in this extract.

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