Cleared Special

K151935 - Alere Signify H. pylori Whole Blood, Serum, Plasma (FDA 510(k) Clearance)

Also includes:
Alere Signify H. pylori Whole Blood Only Alere Clearview H. pylori Whole Blood, Serum, Plasma Alere Clearview H. pylori Whole Blood Only

Class I Microbiology device.

K151935 · Alere San Diego, Incorporated · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
29d
Days
Class 1
Risk

K151935 is an FDA 510(k) clearance for the Alere Signify H. pylori Whole Blood, Serum, Plasma. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Alere San Diego, Incorporated (San Diego, US). The FDA issued a Cleared decision on August 12, 2015 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alere San Diego, Incorporated devices

Submission Details

510(k) Number K151935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2015
Decision Date August 12, 2015
Days to Decision 29 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LYR Helicobacter Pylori
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.