Cleared Special

K183176 - Endotoxin Activity Assay (EAA) (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K183176 · Spectral Medical, Inc. · Microbiology device
Mar 2019
Decision
116d
Days
Class 2
Risk

K183176 is an FDA 510(k) clearance for the Endotoxin Activity Assay (EAA). Classified as Assay, Endotoxin Activity, Chemiluminescent (product code NGS), Class II - Special Controls.

Submitted by Spectral Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on March 12, 2019 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3210 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K183176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2018
Decision Date March 12, 2019
Days to Decision 116 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 174d · This submission: 116d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NGS Assay, Endotoxin Activity, Chemiluminescent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3210
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.