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RIASSIST RAST Data Reduction/Quality

by Ventrex Laboratories, Inc.

510(k) K830170

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 NumberK830170 Date7 Feb 1983ClearedStatusActive

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  • Withdrawn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
DHB
Device Class
Class II
Regulation
21 CFR Part 866.5750
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 RIASSIST RAST Data Reduction/Quality is a System, Test, Radioallergosorbent (RAST) Immunological, designed for processing and analyzing radioallergosorbent test data. It automates the reduction and quality assessment of RAST assay results, improving efficiency in immunology laboratory workflows by minimizing manual data entry and enhancing accuracy in allergen-specific IgE measurements.

This device is intended for use in clinical immunology laboratories and has been cleared under FDA 510(k) K830170 as a Class II medical device (regulation number 866.5750). Supplied as a reusable system, it requires proper calibration and maintenance per manufacturer instructions. No specific sterility or MRI safety information is provided in the regulatory data, and its use is governed by the stated FDA clearance and applicable immunology laboratory standards.

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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 primary purpose of the RIASSIST RAST Data Reduction/Quality system in a clinical immunology lab?

    The RIASSIST RAST Data Reduction/Quality system automates the processing and analysis of radioallergosorbent (RAST) test data. It reduces manual data entry efforts and improves accuracy in measuring allergen-specific IgE levels, which helps streamline workflows in immunology laboratories.

  • Is the RIASSIST RAST Data Reduction/Quality system reusable or single-use, and what maintenance is required?

    The system is designed as a reusable device, meaning it can be used repeatedly in a clinical setting. However, it requires proper calibration and maintenance as outlined in the manufacturer’s instructions to ensure reliable performance and data accuracy.

  • Does the RIASSIST RAST Data Reduction/Quality system have any specific sterility requirements or MRI safety considerations?

    The regulatory data does not mention any sterility requirements for the RIASSIST RAST system, nor does it provide information regarding MRI safety. Laboratories should follow standard immunology laboratory practices and manufacturer guidelines for safe and appropriate use.

  • How is the RIASSIST RAST Data Reduction/Quality system regulated, and what is its intended use category?

    The system is cleared by the FDA under the 510(k) pathway (K830170) as a Class II medical device, with a regulatory classification of 866.5750. It is intended for use in clinical immunology laboratories, specifically for processing and analyzing RAST assay data, as governed by immunology laboratory standards.