Cleared Traditional

K930796 - ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS

K930796 is an FDA 510(k) clearance for ISE CALIBRATORS FOR CORNING 600 SERIES ..., manufactured by Alko Diagnostic Corp.. The device is a Class 1 Immunology device with product code JZX cleared through the Traditional 510(k) pathway after a 331-day FDA review.

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

FDA 510(k) Submission Details - K930796

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 105d · This submission: 331d
Pathway characteristics
Predicate-based equivalence.

JZX Device Classification - Class 1, General Controls

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.