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Liquichek Anti-RNP Control, EIA, Model 207

FDA 510(k)

Class II (US FDA 510(k))

510(k) K984476

by Bio-Rad

Identifiers

510(k) Number
K984476 FDA 510(k)
FDA Product Code
LKO 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-RNP Control, EIA, Model 207 is an enzyme immunoassay (EIA) control designed for use in the detection of anti-RNP (anti-Ribonucleoprotein) antibodies. Classified as an Anti-RNP Antibody, Antigen, and Control under FDA regulation 866.5100, this device is intended for immunology testing and serves as a quality control measure in diagnostic assays.

This control is supplied as a ready-to-use liquid reagent, intended for single-use in clinical laboratory settings. It is not sterile but is packaged to prevent contamination. The device is classified as a Class II medical device and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of December 22, 1998. Storage instructions and additional regulatory details are specified in the accompanying documentation.

Frequently asked questions

What is the Liquichek Anti-RNP Control, EIA, Model 207 used for in clinical testing?

This device is an enzyme immunoassay (EIA) control specifically designed for quality control purposes in immunology testing. It helps ensure the accuracy and reliability of diagnostic assays that detect anti-RNP (anti-Ribonucleoprotein) antibodies, which are relevant for conditions like connective tissue diseases.

Is the Liquichek Anti-RNP Control, EIA, Model 207 sterile, and how should it be handled?

The Liquichek Anti-RNP Control is not sterile, but it is packaged to minimize contamination risk. Since it is a ready-to-use liquid reagent, it should be handled in a controlled clinical laboratory environment, adhering to standard aseptic practices for non-sterile reagents. Always follow the manufacturer’s instructions for storage and usage.

Can this control be reused, or is it intended for single-use only?

The Liquichek Anti-RNP Control is explicitly supplied as a single-use liquid reagent. It is designed for one-time use in diagnostic assays to maintain consistency and reliability in quality control testing. Reusing it could compromise accuracy and introduce contamination risks.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

This device received FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with U.S. safety and performance standards for immunology testing controls, ensuring it can be legally used in clinical laboratories for anti-RNP antibody assay validation.

How should this control be stored, and are there any special considerations for its shelf life?

Storage instructions are detailed in the accompanying documentation, but generally, non-sterile liquid controls like this should be stored according to the manufacturer’s guidelines—typically at room temperature or refrigerated, away from direct light and extreme temperatures. Always verify the expiration date and follow Bio-Rad’s recommendations to ensure optimal performance and validity.

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: PDF K984476 - Liquichek Anti-rnp Control, Eia, Model 207, LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 510 (k) K984476 - FDA.report, FDA Browser - Cleared 510 (K) - LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL ..., fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K984476 24 fields · synced Sep 19, 2026