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Liquichek Anti-DsDNA Control, Model 213

FDA 510(k)

Class II (US FDA 510(k))

510(k) K984396

by Bio-Rad

Identifiers

510(k) Number
K984396 FDA 510(k)
FDA Product Code
LRM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5100 FDA 510(k)
Regulation Number
866.5100 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Liquichek Anti-DsDNA Control, Model 213, is an enzyme-labeled antigen control designed for use in immunoassays. It serves as an unassayed quality control to monitor the performance of assays detecting dsDNA autoantibodies, ensuring assay accuracy and reliability in clinical testing.

This liquid, human serum-based control is intended for use in immunology laboratories. Supplied in a sterile, single-use format, it requires storage at 2–8°C and maintains stability for six months when the vial remains unopened. The device holds an FDA 510(k) clearance (K984396) and is classified under product code LRM as a Class II device under special controls.

Frequently asked questions

What is the Liquichek Anti-DsDNA Control, Model 213, used for in a clinical setting?

The Liquichek Anti-DsDNA Control, Model 213, is an enzyme-labeled antigen control designed specifically for immunoassays that detect dsDNA autoantibodies. It acts as an unassayed quality control to help ensure the accuracy and reliability of these tests in immunology laboratories, allowing clinicians to monitor assay performance.

Is the Liquichek Anti-DsDNA Control, Model 213, intended for single-use or can it be reused?

The Liquichek Anti-DsDNA Control, Model 213, is supplied in a sterile, single-use format. This means each vial is meant to be used once and should not be reused to maintain sterility and reliability.

How should the Liquichek Anti-DsDNA Control, Model 213, be stored, and what is its shelf life?

The control should be stored at a refrigerated temperature between 2–8°C. When kept unopened, it remains stable for six months from the date of manufacture, ensuring optimal performance during this period.

What regulatory pathway was followed for the FDA clearance of the Liquichek Anti-DsDNA Control, Model 213?

The Liquichek Anti-DsDNA Control, Model 213, received FDA clearance through a traditional 510(k) pathway, classified as substantially equivalent under product code LRM. The submission was reviewed by the Immunology (IM) Advisory Committee in 1998, and the device holds clearance number K984396.

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: LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 (K984396) — FDA 510 (k ..., dsDNA Controls - Bio-Rad, K984396 - LIQUICHEK ANTI-DSDNA CONTROL | FDA 510(k) | Bio-Rad, dsDNA Controls - Bio-Rad

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K984396 24 fields · synced Sep 19, 2026