Cleared Traditional

CPR SLIDE EIKEN (K854819) - FDA 510(k) Clearance

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

K854819 · Syn-Kit, Inc. · Immunology device
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Feb 1986
Decision
85d
Days
Class 2
Risk

K854819 is an FDA 510(k) clearance for the CPR SLIDE EIKEN. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Syn-Kit, Inc. (Chatsworth, US). The FDA issued a Cleared decision on February 26, 1986 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - the FDA immunology 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 Syn-Kit, Inc. devices

Submission Details

510(k) Number K854819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1985
Decision Date February 26, 1986
Days to Decision 85 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 104d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCN System, Test, C-reactive Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 Immunology devices follow this clearance model.

Regulatory Peers - DCN System, Test, C-reactive Protein

All 69
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K854819.
CardioPhase® hsCRP
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Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
K172868 · The Binding Site Group , Ltd. · Feb 2018
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K171498 · Meso Scale Diagnostics, LLC · Jan 2018