IGA
by Abbott Laboratories 510(k)
Active
510(k) K983359
Overview
The IGA is a diagnostic reagent set classified as an Antigen, Antiserum, and Control for immunology applications. It is designed for use in serological testing to detect specific antibodies or antigens, aiding in the diagnosis of immune-related conditions. The device comprises multiple components, including antigens, antisera, and controls, each identified by unique registration numbers. Its primary function aligns with immunology testing protocols, supporting laboratory workflows for accurate diagnostic results.
The IGA is supplied as a multi-component reagent set, intended for single-use in clinical laboratory settings. It is regulated under FDA 510(k) clearance (K983359) and falls under the product code CZP, categorized under regulation number 866.5510. Components are distributed in sterile, pre-packaged formats, with no indication of MRI compatibility or reusable design. Storage and handling must adhere to standard laboratory protocols for diagnostic reagents to maintain integrity and accuracy. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983359 | Date4 Nov 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1988-2019
An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
Specification
- 510(k) Number
- FDA Product Code
- CZP
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5510
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What types of immune-related conditions can the IGA diagnostic reagent set help diagnose, and how does it function in serological testing?
The IGA is designed for serological testing to detect specific antibodies or antigens, aiding in the diagnosis of immune-related conditions within clinical laboratory settings. It functions by providing a multi-component reagent set—including antigens, antisera, and controls—that supports immunology testing protocols. While the exact conditions it targets aren’t specified, its role aligns with standard immunology workflows to ensure accurate diagnostic results.
Is the IGA intended for single-use only, and if so, how should it be stored to maintain its integrity?
Yes, the IGA is explicitly supplied for single-use in clinical laboratories. To maintain its integrity, storage and handling must follow standard laboratory protocols for diagnostic reagents. Since it’s pre-packaged and sterile, it should be kept in a controlled environment—protected from contamination, extreme temperatures, and light—until use, as per typical immunology reagent guidelines.
What regulatory pathway does the IGA follow, and how does this affect its use in clinical settings?
The IGA is regulated under the FDA’s 510(k) clearance pathway (K983359) and classified under product code CZP (regulation number 866.5510). This means it has been deemed substantially equivalent to a predicate device by the FDA’s Immunology (IM) Advisory Committee. Clinically, this clearance ensures it meets FDA standards for safety and effectiveness in immunology testing, but users should always refer to the manufacturer’s instructions for specific protocol adherence.
How many unique components does the IGA reagent set include, and are they all sterile?
The IGA consists of multiple components, each with its own registration number (e.g., 3016438761, 1000403749, etc.), totaling over a dozen distinct items. All components are supplied in sterile, pre-packaged formats, ensuring no cross-contamination risk before use. This sterility is critical for accurate immunology testing, as contamination could compromise diagnostic reliability.
Can the IGA be reused, or is it strictly for one-time diagnostic use?
The IGA is explicitly designed for single-use only, as stated in its supply specifications. Reusing components could introduce errors, cross-contamination, or inaccurate results, which are unacceptable in clinical immunology testing. Laboratories must adhere to this restriction to maintain the integrity of diagnostic workflows and patient safety.