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SeraQuest Anti-Sm

by Quest Intl., Inc.

510(k) K980540

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980540 Date15 Jun 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LKP
Device Class
Class II
Regulation
21 CFR Part 866.5100
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SeraQuest Anti-Sm is a solid-phase enzyme immunoassay (EIA) for the qualitative and semi-quantitative detection of IgG antibodies to Sm/RNP in human serum. This in vitro diagnostic device leverages microwells coated with Sm antigen to facilitate antibody binding, enabling laboratory-based testing for systemic rheumatic disease markers, particularly in autoimmune conditions.

Intended for use in clinical laboratories, the device is supplied as a single-use diagnostic kit and requires no special storage conditions beyond standard refrigeration. It is classified as a Class II medical device under FDA regulations (510(k) clearance K980540) and adheres to immunology-specific standards for in vitro diagnostics. No MRI safety or reusable components are indicated in the specifications.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SeraQuest Anti-Sm used for in clinical practice?

    The SeraQuest Anti-Sm is designed for detecting IgG antibodies to Sm/RNP in human serum, which serves as a marker for systemic rheumatic diseases, particularly autoimmune conditions. It helps laboratories identify these antibodies to aid in diagnosing or monitoring conditions like systemic lupus erythematosus (SLE) or other connective tissue disorders.

  • Is the SeraQuest Anti-Sm kit single-use, or can it be reused?

    The SeraQuest Anti-Sm is explicitly supplied as a single-use diagnostic kit. It is not intended for reuse, as it is a solid-phase enzyme immunoassay (EIA) with microwells coated for one-time testing. Reusing components could compromise accuracy and sterility.

  • What storage conditions are required for the SeraQuest Anti-Sm kit?

    The kit does not require special storage conditions beyond standard refrigeration. This ensures stability while maintaining the integrity of the reagents for qualitative and semi-quantitative antibody detection.

  • How was the regulatory pathway for the SeraQuest Anti-Sm determined?

    The device was classified as substantially equivalent (SESE) under the FDA’s 510(k) pathway, with a traditional review process. It was submitted to the Immunology (IM) Advisory Committee and received clearance under product code LKP, confirming its compliance with immunology-specific in vitro diagnostic standards.

  • Does the SeraQuest Anti-Sm kit include controls, and if so, what are they used for?

    Yes, the kit includes antigen and control components (as referenced in the registration numbers). These controls are essential for validating test performance, ensuring accuracy in detecting IgG antibodies to Sm/RNP and confirming the reliability of each assay run.