Cleared Traditional

K844848 - IMA-TROL IMMUNOASSAY CONTROL

K844848 is the FDA 510(k) clearance for IMA-TROL IMMUNOASSAY CONTROL by Dimension Diagnostics. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K844848 · Dimension Diagnostics · Chemistry device
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Mar 1985
Decision
78d
Days
Class 1
Risk

K844848 is an FDA 510(k) clearance for the IMA-TROL IMMUNOASSAY CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Dimension Diagnostics (St. Charles, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 78 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 Dimension Diagnostics devices

Submission Details

510(k) Number K844848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1984
Decision Date March 01, 1985
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
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 475
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K844848.
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO
K850574 · American Dade · Apr 1985
DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H
K850575 · American Dade · Apr 1985
PRECINORM H & PRECIPATH H
K850017 · Boehringer Mannheim Corp. · Mar 1985
ULTROSER G
K844413 · Lkb Instruments, Inc. · Feb 1985
PARAGON TRICHECK ELECTROPHORESIS CONTROL
K844996 · Beckman Instruments, Inc. · Feb 1985
GELMAN TRIPHOR CONTROL
K850202 · Gelman Sciences, Inc. · Feb 1985