Modification to Reaads Anti-Phosphatidylserine Iga Semi-Quantative Test Kit
510(k) K024195
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK024195 | Date3 Jan 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MID
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5660
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is an in vitro diagnostic test kit for the detection and semi-quantitative measurement of IgA anti-phosphatidylserine antibodies in human serum or plasma. It falls under the category of immunological assays, specifically designed for use in diagnosing or monitoring systemic lupus erythematosus (SLE) and lupus-like disorders, such as antiphospholipid syndrome. The kit employs immunological techniques to identify and quantify specific antibodies linked to these conditions.
The REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit is supplied as a single-use diagnostic tool, intended for use in clinical laboratory settings. It is classified as a Class II medical device under FDA regulations, with a 510(k) clearance granted through a Special 510(k) pathway. The kit requires proper storage and handling as per manufacturer instructions to maintain accuracy and reliability, ensuring compliance with regulatory standards for in vitro diagnostics.
Other devices from Corgenix, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit used for?
This test kit detects and measures IgA antibodies against phosphatidylserine in human serum or plasma. These antibodies are associated with systemic lupus erythematosus (SLE) and lupus-like disorders, such as antiphospholipid syndrome, helping clinicians diagnose or monitor these conditions through immunological assay techniques.
Is the REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit single-use or reusable?
The kit is designed for single-use only. This ensures accuracy and reliability by preventing cross-contamination between tests, which is critical for in vitro diagnostics where precision matters. Each kit is intended for one use in a clinical laboratory setting.
How should the REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit be stored?
Proper storage is essential to maintain the kit’s accuracy and performance. Follow the manufacturer’s instructions for storage conditions, which typically include protecting the kit from extreme temperatures, moisture, and light. Adhering to these guidelines ensures compliance with regulatory standards and preserves the integrity of the diagnostic assay.
What regulatory pathway was used for FDA clearance of this test kit?
The REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit received FDA clearance through the Special 510(k) pathway. This pathway is used for modifications to previously cleared devices, ensuring that the changes maintain substantial equivalence to the original device. The kit is classified as a Class II medical device under FDA regulations.
Where can this test kit be used, and what type of facility requires it?
This test kit is intended exclusively for use in clinical laboratory settings. It is not designed for point-of-care or home testing. Laboratories must follow strict protocols for handling, storage, and disposal to ensure reliable results and compliance with regulatory requirements for in vitro diagnostics.