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Hep-2000 Colorzyme Ana-Ro Test System, Model 4200-Ro

FDA 510(k)

Class II (US FDA 510(k))

510(k) K983924

by Immuno Concepts Inc

Identifiers

510(k) Number
K983924 FDA 510(k)
FDA Product Code
DHN 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 HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO is an antinuclear antibody, indirect immunofluorescent, antigen, control device used in immunology testing. It is designed for the detection of autoantibodies, particularly SS-A/Ro, using a genetically engineered HEp-2000 cell line to enhance sensitivity in indirect immunofluorescence assays.

This device is supplied as a test system and is authorized under FDA 510(k) clearance (K983924). It is intended for use in laboratory settings and is classified as a Class II medical device under regulation number 866.5100. The product is manufactured by Immuno Concepts Inc. and is not described as sterile, single-use, reusable, or MRI-safe in the provided data.

Frequently asked questions

What is the HEP-2000 COLORZYME ANA-RO Test System, Model 4200-RO used for?

This device is used to detect autoantibodies, particularly SS-A/Ro, in immunology testing. It employs an indirect immunofluorescent method with a genetically engineered HEp-2000 cell line as the antigen substrate to enhance sensitivity in identifying antinuclear antibodies.

How is the HEP-2000 COLORZYME ANA-RO Test System, Model 4200-RO supplied and authorized?

The device is supplied as a test system and received FDA 510(k) clearance under K983924 on December 18, 1998. It is classified as a Class II medical device under regulation 866.5100 and was found substantially equivalent to a predicate device.

Is the HEP-2000 COLORZYME ANA-RO Test System, Model 4200-RO sterile or single-use?

The provided data does not describe this device as sterile, single-use, reusable, or MRI-safe. Therefore, no claims about sterility or single-use status can be made based on the available information.

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: ANA HEp-2000® Colorzyme® Test System | Immuno Concepts, ANA HEp-2000® Fluorescent Test System | Immuno Concepts, Hep-2000 Colorzyme Ana-ro Test System, Model 4200-ro, Colorzyme Test System - Centro Pharm

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Immuno Concepts Inc
FDA Applicant
Immuno Concepts, Inc.

Sources (1)

  • FDA 510(k) K983924 24 fields · synced Sep 22, 2026