Cleared Special

K162961 - LIAISON VCA IgG and LIAISON VCA IgG Ser...

Also marketed or referenced as:
LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set

K162961 is an FDA 510(k) clearance for LIAISON VCA IgG and LIAISON VCA IgG Ser..., manufactured by DiaSorin, Inc.. The device is a Class 1 Microbiology device with product code LSE cleared through the Special 510(k) pathway after a 73-day FDA review.

K162961 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF)
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Jan 2017
Decision
73d
Days
Class 1
Risk

K162961 is an FDA 510(k) clearance for the LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on January 5, 2017 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - 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 DiaSorin, Inc. devices

FDA 510(k) Submission Details - K162961

510(k) Number K162961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2016
Decision Date January 05, 2017
Days to Decision 73 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 102d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

LSE Device Classification - Class 1, General Controls

Product Code LSE Epstein-barr Virus, Other
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
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.

Regulatory Peers - LSE Epstein-barr Virus, Other

All 34
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