FDA - Influenza Rapid Test Reclassification (Class II) Effective January 12, 2018

Dear All,

We are very sorry to inform you that due to recent FDA regulatory changes, we will not be carrying the Rapid Response™ Flu Kit for the time being. We understand this may cause inconveniences, however, this is strictly due to the FDA’s recent reclassification. As per the FDA ruling, tests that fell under the original Class I (current Rapid- Response™ Flu Kits) cannot be marketed, sold or distributed after January 12. However, any affected products purchased prior to January 12, 2018 may still be used until their expiration date. We have already submitted for our Class II approval with the FDA and we will gladly contact our clientele via the Lochness Medical website with any future updates.

In accordance with the new reclassification, the FDA has provided the following details and reasoning for the changes:

  • The FDA will be requiring special controls to establish an improved industry standard for testing (a call-to-action to address the industry concerns exposed in the 2009 Flu pandemic).
  • New Class II tests will require premarket notification and controls that will be used to Identify and test for newly emerging strains of the Influenza virus as well as contemporary strains.
  • The goal is to improve the overall number of misdiagnosed treatments.
  • In collaboration with the Centers for Disease Control and Prevention, the FDA will provide an Influenza Virus Analytical Reactivity Test Panel to all manufacturers of antigen-based RIDTs in order to evaluate the reactivity of their assays with current and circulating viruses.

We hope this clarifies any questions you might have regarding the indefinite suspension to the industries availability to Rapid Flu Tests. Again, updates will be available at www.lochnessmedical.com.

Sincerely,

Lochness Medical Inc.


The Rapid ResponseTM Influenza A and Influenza B Test Cassettes are rapid, qualitative tests for the detection of influenza type A and B nucleoprotein antigens from nasal washes and aspirate samples, to aid in the diagnosis of influenza A and influenza B infections. They are intended for professional in vitro diagnostic use only. Interpretation of test results are: Flu A OR Flu B positive (two lines), negative (one line), invalid (no lines or no Control line).

Product Information
  • Product Code: FLUAB-19C15
  • Sample: Nasopharyngeal Washes and Aspirates
  • Format: Cassette
  • Specificity: Influenza A & Influenza B Antigens
  • Accuracy: Flu A: 91.6%, Flu B: 99.2%
  • Time-to-Result: 15 minutes
  • Storage Condition: 59-86°F/15-30°C
  • Test Principle: Lateral Flow Immunoassay
Contents
  • 15 Flu A Test Cassettes
  • 15 Flu B Test Cassettes
  • 30 Extraction Tubes with Filter Caps
  • 60 Disposable 250μl Pipettes
  • 2 Bottles of Extraction Buffer (15 mL each)
  • Product Inserts
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