Identifiers
- 510(k) Number
- K922351 FDA 510(k)
- FDA Product Code
- MID FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5660 FDA 510(k)
- Regulation Number
- 866.5660 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Quanta Lite IGA ACA is an Immunological Test System for detecting anticardiolipin antibodies (ACA) in serum or plasma. It employs immunoassay technology to quantify IgA-class ACA, aiding in the diagnosis and monitoring of autoimmune conditions, such as antiphospholipid syndrome.
This device is intended for in vitro diagnostic use in clinical laboratories. Supplied as a single-use reagent kit, it requires no special storage conditions beyond refrigeration (2–8°C) and is compatible with standard laboratory equipment. The system carries an FDA 510(k) clearance (K922351) under the MID product code, adhering to regulatory standards for immunological diagnostic tests.
Frequently asked questions
What autoimmune conditions can the Quanta Lite IGA ACA help diagnose or monitor, and how does it do this?
The Quanta Lite IGA ACA is designed to detect IgA-class anticardiolipin antibodies (ACA) in serum or plasma, aiding in the diagnosis and monitoring of autoimmune conditions like antiphospholipid syndrome. It uses immunoassay technology to quantify these antibodies, helping clinicians assess potential immune system dysfunction linked to these conditions.
Is the Quanta Lite IGA ACA kit meant for single-use, and if so, what storage conditions are required?
Yes, the Quanta Lite IGA ACA is supplied as a single-use reagent kit. It requires standard refrigeration between 2–8°C and does not need any additional special storage conditions, making it compatible with typical laboratory environments.
How is the Quanta Lite IGA ACA intended to be used in a clinical setting, and what type of laboratory equipment is compatible with it?
The Quanta Lite IGA ACA is intended for in vitro diagnostic use in clinical laboratories. It is designed to work with standard laboratory equipment, allowing for straightforward integration into existing workflows for immunological testing.
What regulatory pathway was followed for the FDA clearance of the Quanta Lite IGA ACA, and what does this mean for its use?
The Quanta Lite IGA ACA received FDA clearance through a 510(k) submission, specifically under the Traditional clearance type and classified as substantially equivalent (SESE) to a predicate device. This means the device meets regulatory standards for immunological diagnostic tests and is authorized for use in clinical settings as described in its labeling.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: QUANTA LITE (TM) IGA ACA (K922351) - FDA 510 (k), QUANTA LITE(TM) IGA ACA (K922351) — FDA 510(k) | Innolitics, QUANTA LITE (TM) ACA (K911680) - FDA 510 (k), QUANTA LITE(TM) IGA ACA 510(k) K922351 - FDA.report, QUANTA LITE (TM) ACA (K911680) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K922351 | Class II | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA 510(k) K922351 24 fields · synced Sep 19, 2026