Cleared Traditional

K173683 - LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers (FDA 510(k) Clearance)

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

K173683 · DiaSorin, Inc. · Microbiology device
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Feb 2018
Decision
88d
Days
Class 2
Risk

K173683 is an FDA 510(k) clearance for the LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS .... Classified as Procalcitonin Assay (product code PRI), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on February 27, 2018 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K173683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2017
Decision Date February 27, 2018
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PRI Procalcitonin Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3215
Definition To Aid In Decision Making On Antibiotic Therapy, Including Antibiotic Initiation And Discontinuation, For Inpatients Or Patients In The Emergency Department, With Suspected Or Confirmed Lower Respiratory Tract Infections (lrti) Defined As Community-acquired Pneumonia (cap), Acute Bronchitis, And Acute Exacerbation Of Chronic Obstructive Pulmonary Disease (aecopd).
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.