Cleared Traditional

K213936 - LIAISON MeMed BV, LIAISON MeMed BV Control Set (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213936 · DiaSorin, Inc. · Microbiology device
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Jul 2022
Decision
210d
Days
Class 2
Risk

K213936 is an FDA 510(k) clearance for the LIAISON MeMed BV, LIAISON MeMed BV Control Set. Classified as Immunoassay For Host Biomarkers Of Infection (product code QPS), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on July 14, 2022 after a review of 210 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3215 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K213936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2021
Decision Date July 14, 2022
Days to Decision 210 days
Submission Type Traditional
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
108d slower than avg
Panel avg: 102d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QPS Immunoassay For Host Biomarkers Of Infection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3215
Definition A Semi-quantitative Immunoassay That Quantifies The Relative Levels Of Host Response Proteins Isolated From Serum Or Similar Specimens.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.