Cleared Traditional

K912718 - ENZYME LINEARITY CONTROL

K912718 is an FDA 510(k) clearance for ENZYME LINEARITY CONTROL, manufactured by Phoenix Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K912718 · Phoenix Diagnostics, Inc. · Chemistry device
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Sep 1991
Decision
80d
Days
Class 1
Risk

K912718 is an FDA 510(k) clearance for the ENZYME LINEARITY CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Phoenix Diagnostics, Inc. (Medfield, US). The FDA issued a Cleared decision on September 6, 1991 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: 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 Phoenix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K912718

510(k) Number K912718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date September 06, 1991
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 88d · 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 546
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K912718.
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TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
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K912441 · Boehringer Mannheim Corp. · Jul 1991