Cleared Traditional

SYVA ETS SYSTEM (K863245) - FDA 510(k) Clearance

Class I Chemistry device.

K863245 · Syva Co. · Chemistry device
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Mar 1987
Decision
203d
Days
Class 1
Risk

K863245 is an FDA 510(k) clearance for the SYVA ETS SYSTEM. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on March 13, 1987 after a review of 203 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - the FDA in vitro diagnostics and chemistry 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Syva Co. devices

Submission Details

510(k) Number K863245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1986
Decision Date March 13, 1987
Days to Decision 203 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 88d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.