Cleared Traditional

K874772 - DC-TROL LEVEL 1 OR 2

K874772 is the FDA 510(k) clearance for DC-TROL LEVEL 1 OR 2 by Diagnostic Chemicals, Ltd. (Usa). It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K874772 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Jan 1988
Decision
47d
Days
Class 1
Risk

K874772 is an FDA 510(k) clearance for the DC-TROL LEVEL 1 OR 2. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Monroe, US). The FDA issued a Cleared decision on January 5, 1988 after a review of 47 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K874772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date January 05, 1988
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 464
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K874772.
LYPHOCHEK WHOLE BLOOD CONTROL
K874731 · Bio-Rad · Feb 1988
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II
K874280 · Bio-Rad · Jan 1988
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM
K874809 · Biotrol, USA, Inc. · Jan 1988
REFERENCE ASSAYED CHEMISTRY CONTROL SERUM
K874810 · Biotrol, USA, Inc. · Jan 1988
PRECINORM L
K874230 · Boehringer Mannheim Corp. · Nov 1987
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL
K872777 · Biotrol, USA, Inc. · Aug 1987