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Ramp Influenza A/B Assay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093116

by Response Biomedical Corp.

Identifiers

510(k) Number
K093116 FDA 510(k)
FDA Product Code
PSZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3328 FDA 510(k)
Regulation Number
866.3328 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ramp Influenza A/B Assay is a lateral flow immunoassay for qualitative detection of Influenza A and B viral antigens in nasal swab specimens. It is a device detecting influenza A, B, and C virus antigens, classified under the medical specialty of Microbiology.

The assay is supplied with an updated analytical reactivity table to include the 2009 H1N1 Influenza strain A/Swine NY/02/2009. The device has a product code of PSZ and is regulated under regulation number 866.3328, with a decision description of Substantially Equivalent.

Frequently asked questions

What is the Ramp Influenza A/B Assay used for?

The Ramp Influenza A/B Assay is a lateral flow immunoassay designed for the qualitative detection of Influenza A and B viral antigens in nasal swab specimens. It helps clinicians quickly identify influenza infections in patients.

How is the assay supplied and what does it include?

The assay is supplied with an updated analytical reactivity table that includes the 2009 H1N1 Influenza strain A/Swine NY/02/2009. This ensures the device can detect this specific strain along with other influenza types.

Is the Ramp Influenza A/B Assay a single-use device?

The device information does not specify whether it is single-use or reusable. Clinicians should refer to the manufacturer's instructions for use to determine the appropriate handling and disposal procedures for this assay.

What regulatory approvals does this assay have?

The Ramp Influenza A/B Assay has received FDA 510(k) clearance with a decision description of 'Substantially Equivalent.' It is classified under product code PSZ and regulated under number 866.3328.

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: MODIFICATION TO: RAMP INFLUENZA A/B ASSAY (K093116) — FDA 510(k ..., MODIFICATION TO: RAMP INFLUENZA A/B ASSAY 510(k) K093116 - fda.report, K093116 - MODIFICATION TO: RAMP INFLUENZA A/B ASSAY FDA 510 (k ..., fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Response Biomedical Corp.

Sources (1)

  • FDA 510(k) K093116 24 fields · synced Sep 26, 2026