Cleared Traditional

K930796 - ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS (FDA 510(k) Clearance)

Class I Immunology device.

K930796 · Alko Diagnostic Corp. · Immunology device
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Jan 1994
Decision
331d
Days
Class 1
Risk

K930796 is an FDA 510(k) clearance for the ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS. Classified as Equipment, Rocket Immunoelectrophoresis (product code JZX), Class I - General Controls.

Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on January 13, 1994 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4830 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alko Diagnostic Corp. devices

Submission Details

510(k) Number K930796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1993
Decision Date January 13, 1994
Days to Decision 331 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
227d slower than avg
Panel avg: 104d · This submission: 331d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZX Equipment, Rocket Immunoelectrophoresis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4830
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.