Cleared Traditional

K942922 - SELECTA 20/60 CHEMISTRY ANALYZER

K942922 is an FDA 510(k) clearance for SELECTA 20/60 CHEMISTRY ANALYZER, manufactured by Select Medical Systems, Inc.. The device is a Class 1 Chemistry device with product code JJE cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K942922 · Select Medical Systems, Inc. · Chemistry device
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Jul 1995
Decision
393d
Days
Class 1
Risk

K942922 is an FDA 510(k) clearance for the SELECTA 20/60 CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Select Medical Systems, Inc. (Birmingham, US). The FDA issued a Cleared decision on July 19, 1995 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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. Elevated predicate reliance profile. 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 Select Medical Systems, Inc. devices

FDA 510(k) Submission Details - K942922

510(k) Number K942922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1994
Decision Date July 19, 1995
Days to Decision 393 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
305d slower than avg
Panel avg: 88d · This submission: 393d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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.

Regulatory Peers - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 159
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