Cleared Special

K183176 - Endotoxin Activity Assay (EAA)

K183176 is an FDA 510(k) clearance for Endotoxin Activity Assay (EAA), manufactured by Spectral Medical, Inc.. The device is a Class 2 Microbiology device with product code NGS cleared through the Special 510(k) pathway after a 116-day FDA review.

K183176 · Spectral Medical, Inc. · Microbiology device
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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.

FDA 510(k) Submission Details - K183176

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 102d · This submission: 116d
Pathway characteristics
Modification to existing cleared device.

NGS Device Classification - Class 2, Special Controls

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.

K183176 · Endotoxin Activity Assay (EAA)
Download PDF Spectral Medical, Inc.