← Back to catalogue

Quanta Lite Aca Screen (hrp)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K953291

by Inova Diagnostics, Inc.

Identifiers

510(k) Number
K953291 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 ACA SCREEN (HRP) is a System, Test, Anticardiolipin Immunological device used for the detection of anticardiolipin antibodies in human serum or plasma. It is classified under medical specialty Immunology and regulation number 866.5660.

The device received FDA 510(k) clearance (K953291) on August 29, 1995, following a traditional review process. It is manufactured by Inova Diagnostics, Inc. and assigned product code MID. The device is intended for use in laboratory settings as an immunological test system.

Frequently asked questions

What is the QUANTA LITE ACA SCREEN (HRP) used for?

The QUANTA LITE ACA SCREEN (HRP) is used for the detection of anticardiolipin antibodies in human serum or plasma. It is an immunological test system intended for laboratory settings to support the assessment of autoimmune conditions associated with these antibodies.

How is the QUANTA LITE ACA SCREEN (HRP) supplied and is it single-use or reusable?

The device is supplied as a test system for laboratory use, consisting of reagents and components designed for performing the anticardiolipin antibody assay. It is intended for single-use per test run, as is standard for immunological test kits, to ensure accuracy and prevent cross-contamination between patient samples.

What regulatory pathway was used for the QUANTA LITE ACA SCREEN (HRP) and when was it cleared?

The QUANTA LITE ACA SCREEN (HRP) received FDA 510(k) clearance through a traditional review process. It was cleared on August 29, 1995, under submission number K953291, demonstrating substantial equivalence to a legally marketed predicate device.

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 ACA SCREEN (HRP) (K953291) - FDA 510 (k), QUANTA LITE ACA SCREEN (HRP) (K953291) — FDA 510(k) | Innolitics, QUANTA LITE ACA SCREEN (HRP) 510 (k) K953291 - FDA.report, QUANTA LITE ACA SCREEN (K923320) - FDA 510 (k), QUANTA Lite | Werfen North America

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (1)

  • FDA 510(k) K953291 24 fields · synced Sep 26, 2026