Tryptase Test System

Published On -

I3CGlobal IVDR, FDA 510k

FDA 510K for Tryptase Test System

The “Tryptase Test System IVD” is an in vitro diagnostic tool designed to assess the concentration of tryptase, a protein predominantly located in mast cells, within a patient’s blood sample. This measurement aids in the diagnosis of conditions such as mastocytosis, characterized by an excessive number of mast cells, by identifying increased levels of tryptase, especially when interpreted alongside other clinical indicators. It serves fundamentally as a marker for mast cell activation and possible allergic responses.

Intended Use of Tryptase Test System

A Tryptase Test System is a device that aids in the diagnosis of systemic mastocytosis. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.

For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Tryptase Test System
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FDA 510K for Tryptase Test System Device Code and Regulation Number

S

No.

 Product

Code

 Device Regulation Description Regulation

Number

 Device

Class
1. OYL Tryptase Assay System Tryptase test system 866.5760 2

Tryptase Assay System

Intended Use:

Tryptase is an in vitro semi-quantitative assay for measurement of tryptase in human serum or plasma (EDTA, lithium heparin or sodium heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.

Device Description:

Tryptase reagents are modular in concept and are available individually in different package sizes dependent on instrument system used. Instrument System with associated software process all steps of the assay and calculate results automatically after the assay is completed.

Performance Testing (Analytical) for Tryptase Test System

  • Stability Studies
  • Precision/Reproducibility
  • Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
  • Linearity/assay reportable range
  • Traceability (controls, calibrators, or method)
  • Retrospective Study
  • Analytical Sensitivity
  • Analytical Specificity (Cross Reactivity)
  • Interfering Substances
  • Prozone effect study

Clinical Testing:

No Guidance available for 510k submission.

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