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Rubenostika IGM Microelisa System

by Organon Teknika Corp. 510(k)

Active United States

510(k) K882999

Overview

The Rubenostika IGM Microelisa System is an enzyme-linked immunosorbent assay (ELISA) device designed for the qualitative detection of IgM antibodies to rubella virus in human serum or plasma. It employs a solid-phase enzyme immunoassay technique to identify recent rubella infections by detecting specific IgM antibodies.

This system is intended for in vitro diagnostic use in clinical microbiology laboratories. Supplied as a kit, it includes all necessary reagents and components for single-use testing, requiring no additional sterilization. The device is classified under FDA regulation 866.3510 and was granted FDA 510(k) clearance (K882999) as substantially equivalent to a predicate device. Storage and handling follow standard laboratory protocols for immunoassay reagents.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK882999 Date31 Jan 1989ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Rubenostika(Tm) Igm Microelisa System
510(k) Number
FDA Product Code
LFX
Device Class
Class II
Regulation
21 CFR Part 866.3510
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What clinical purpose does the Rubenostika IGM Microelisa System serve in a lab setting?

    The Rubenostika IGM Microelisa System is designed to qualitatively detect IgM antibodies to the rubella virus in human serum or plasma. This helps identify recent rubella infections, as IgM antibodies typically appear early in the immune response to the virus. It is intended for use in clinical microbiology laboratories to aid in diagnosing active rubella cases.

  • Is the Rubenostika IGM Microelisa System intended for single-use or repeated use?

    The Rubenostika IGM Microelisa System is supplied as a kit for single-use testing. Since it includes all necessary reagents and components, no additional sterilization is required, and each kit is meant to be used once per test.

  • What storage and handling requirements apply to this device?

    The Rubenostika IGM Microelisa System follows standard laboratory protocols for immunoassay reagents. While the exact storage conditions are not detailed, typical ELISA kits require refrigeration (2–8°C) and protection from light until use. Always refer to the included instructions for precise storage guidelines.

  • How was the regulatory pathway for this device determined?

    The Rubenostika IGM Microelisa System was classified under FDA regulation 866.3510 and granted FDA 510(k) clearance (K882999) through a traditional review process. It was determined to be substantially equivalent to a predicate device, meaning its safety and effectiveness were compared to an already approved product in the same category.

  • What type of sample can be tested using this system?

    The Rubenostika IGM Microelisa System is specifically designed to test human serum or plasma samples. It uses an enzyme-linked immunosorbent assay (ELISA) technique to detect IgM antibodies, which are present in these sample types during active rubella infections.