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Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)

by Nanosphere, Inc. 510(k)

Active United States

510(k) K143653

Overview

The Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a nucleic acid test for the identification of respiratory pathogens. It is an automated, multiplexed test designed for the identification of viruses and bacteria that commonly cause respiratory tract infections.

The test is supplied as a flexible, multiplexed panel, and is authorized with an FDA 510K clearance. The device is classified as a class 2 device, with a regulation number of 866.3980, and is used in the field of microbiology.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK143653 Date4 Sep 2015ClearedStatusActive

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
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

5 recalls · 3 ongoing · FDA

    • Ongoing Z-1092-2022 FDA Class II initiated 5 Apr 2022 via K143653, on the same 510(k)

    Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

    • Ongoing Z-2006-2021 FDA Class II initiated 30 Oct 2020

    Potential for a false-negative result.

    • Ongoing Z-0054-2021 FDA Class II initiated 10 Dec 2018

    No results/incorrect results due to failure of the hybridization heater.

    • Terminated Z-0476-2021 FDA Class II initiated 13 Oct 2020 via K143653, on the same 510(k)

    Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.

    • Terminated Z-0477-2021 FDA Class II initiated 13 Oct 2020 via K143653, on the same 510(k)

    Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
OCC
Device Class
Class II
Regulation
21 CFR Part 866.3980
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Verigene RP Flex test used for?

    The Verigene RP Flex test is used for the identification of respiratory pathogens, including viruses and bacteria that commonly cause respiratory tract infections.

  • Is the Verigene RP Flex test supplied as a single-use device?

    The test is supplied as a flexible, multiplexed panel, but its single-use or reuse status is not specified in the provided data.

  • What is the regulatory classification of the Verigene RP Flex test?

    The device is classified as a class 2 device, with a regulation number of 866.3980, and is used in the field of microbiology.

  • What type of clearance does the Verigene RP Flex test have?

    The Verigene RP Flex test has an FDA 510K clearance, indicating that it is substantially equivalent to a predicate device.