Cleared Traditional

K944486 - LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E

K944486 is an FDA 510(k) clearance for LINICAL PROTEIN I CALIBRATION VERIFIERS..., manufactured by International Enzymes, Inc.. The device is a Class 1 Immunology device with product code JJY cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K944486 · International Enzymes, Inc. · Immunology device
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Dec 1994
Decision
80d
Days
Class 1
Risk

K944486 is an FDA 510(k) clearance for the LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by International Enzymes, Inc. (Fallbrook, US). The FDA issued a Cleared decision on December 2, 1994 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - 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 International Enzymes, Inc. devices

FDA 510(k) Submission Details - K944486

510(k) Number K944486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1994
Decision Date December 02, 1994
Days to Decision 80 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 105d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 593
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