N-Assay TIA IgM
by Crestat Diagnostics, Inc. 510(k)
Active
510(k) K933970
Overview
The N-Assay TIA IgM is a nephelometric method for measuring Immunoglobulin M (IgM) levels in serum or plasma. Classified under the product code CFN, it falls within the category of immunology diagnostic devices designed to quantify specific immunoglobulins using light scattering technology. This device is intended for use in clinical laboratories to aid in the diagnosis of immune system-related conditions by providing quantitative measurements of IgM concentrations.
This device is supplied as a reagent kit for in vitro diagnostic use and is intended for single-use only. It is not sterile but is intended to be used in a controlled laboratory environment where sterility is maintained through aseptic technique. The device is classified as Class II under FDA regulations (866.5510) and has received FDA 510(k) clearance (K933970) for substantial equivalence to a predicate device. Storage conditions and shelf life are specified in the accompanying instructions for use, which must be followed to ensure accurate and reliable results.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK933970 | Date22 Mar 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CFN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5510
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Crestat Diagnostics, Inc.
Questions
What is the N-Assay TIA IgM used for in clinical settings?
The N-Assay TIA IgM is designed for measuring Immunoglobulin M (IgM) levels in serum or plasma using nephelometric technology. This quantitative assay aids clinicians in diagnosing immune system-related conditions by providing precise IgM concentration data, supporting differential diagnosis and monitoring of immune responses.
How is the N-Assay TIA IgM supplied, and is it sterile?
The device is supplied as a single-use reagent kit intended for in vitro diagnostic use. It is not sterile but is meant to be used in a controlled laboratory environment where sterility is maintained through aseptic techniques. Always follow the included instructions for use to ensure proper handling and accuracy.
Is the N-Assay TIA IgM intended for single-use or reusable applications?
The N-Assay TIA IgM is explicitly designed for single-use only. This ensures consistency in results and minimizes cross-contamination risks in clinical laboratory settings. Reuse is not recommended or supported by the manufacturer.
What regulatory pathway does the N-Assay TIA IgM follow?
The N-Assay TIA IgM has received FDA 510(k) clearance (K933970) under the substantial equivalence determination, classified under product code CFN for immunology diagnostic devices. This clearance confirms its compliance with FDA regulations for Class II devices (866.5510) and establishes its equivalence to a predicate device.
Where can I find detailed storage instructions and shelf life information?
The storage conditions and shelf life details are outlined in the accompanying instructions for use provided with the N-Assay TIA IgM kit. These instructions must be followed strictly to ensure the accuracy, reliability, and validity of the test results. Always refer to the latest version of the IFU for the most up-to-date guidance.