N-Assay TIA C1-INACTIVATOR Test Kit
by Crestat Diagnostics, Inc. 510(k)
Active
510(k) K965024
Overview
The N-Assay TIA C1-Inactivator Test Kit is an in vitro diagnostic reagent system classified as a Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control under FDA nomenclature. It is designed for the quantitative measurement of C1 inactivator levels in human plasma using an immunoturbidimetric assay. The test detects immune complexes formed between C1 inactivator in the sample and specific antibodies, generating measurable turbidity. This enables clinical assessment of complement system function, particularly relevant in diagnosing hereditary angioedema or monitoring related conditions.
The kit is supplied as a reagent system for use in clinical chemistry laboratories, requiring compatibility with standard automated analyzers. It is intended for single-use and must be stored under controlled conditions as specified in the accompanying instructions. The device holds FDA 510(k) clearance under the Immunology advisory committee, with classification as a Class II medical device (DBA product code). Sterility and regulatory compliance are ensured through manufacturer validation, adhering to FDA regulation 866.5250 for in vitro diagnostics.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK965024 | Date14 Jul 1997 | 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- Withdrawn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
- DBA
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5250
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Crestat Diagnostics, Inc.
Questions
What is the N-Assay TIA C1-Inactivator Test Kit used for?
The N-Assay TIA C1-Inactivator Test Kit is designed for the quantitative measurement of C1 inactivator levels in human plasma. It uses an immunoturbidimetric assay to detect immune complexes between C1 inactivator and specific antibodies, generating measurable turbidity. This helps clinicians assess complement system function, particularly for diagnosing hereditary angioedema or monitoring related conditions.
How is the test kit supplied and what equipment is required?
The kit is supplied as a reagent system intended for use in clinical chemistry laboratories. It is compatible with standard automated analyzers, meaning it requires integration with laboratory equipment capable of performing immunoturbidimetric assays. The kit is not standalone and must be used alongside compatible analyzer systems.
Is the N-Assay TIA C1-Inactivator Test Kit sterile and single-use?
Yes, the kit is manufactured to ensure sterility and is intended for single-use only. This design minimizes contamination risk and ensures accurate, consistent results for each test. Instructions for storage and handling include controlled conditions to maintain sterility and performance.
What regulatory approval does the N-Assay TIA C1-Inactivator Test Kit hold?
The kit holds FDA 510(k) clearance under the Immunology advisory committee, classified as a Class II medical device. It adheres to FDA regulation 866.5250 for in vitro diagnostics, ensuring compliance with manufacturing and performance standards. The clearance was granted as substantially equivalent to a predicate device.
How should the test kit be stored?
The kit must be stored under controlled conditions as specified in the accompanying instructions. Proper storage ensures stability, sterility, and accurate performance. These conditions typically include temperature and humidity controls to prevent degradation of reagents and maintain test validity.