Cleared Traditional

ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (K191184) - FDA 510(k) Clearance

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

K191184 · Ssi Diagnostica A/S · Microbiology device
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Mar 2020
Decision
307d
Days
Class 2
Risk

K191184 is an FDA 510(k) clearance for the ImmuView S pneumoniae and L pneumophila Urinary Antigen Test. Classified as Legionella, Spp., Elisa (product code MJH), Class II - Special Controls.

Submitted by Ssi Diagnostica A/S (Hilleroed, DK). The FDA issued a Cleared decision on March 5, 2020 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3300 - 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. Elevated predicate reliance profile. 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 Ssi Diagnostica A/S devices

Submission Details

510(k) Number K191184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2019
Decision Date March 05, 2020
Days to Decision 307 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
205d slower than avg
Panel avg: 102d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJH Legionella, Spp., Elisa
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3300
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.

Regulatory Consultant

Bentsen Regulatory and Clinicals Consulting, LLC
Christopher Bentsen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.