Cleared Traditional

K854789 - RANGE-CHEK

K854789 is an FDA 510(k) clearance for RANGE-CHEK, manufactured by American Monitor Corp.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K854789 · American Monitor Corp. · Chemistry device
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Jan 1986
Decision
45d
Days
Class 1
Risk

K854789 is an FDA 510(k) clearance for the RANGE-CHEK. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by American Monitor Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 13, 1986 after a review of 45 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.

FDA 510(k) Submission Details - K854789

510(k) Number K854789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1985
Decision Date January 13, 1986
Days to Decision 45 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
44d faster than avg
Panel avg: 89d · This submission: 45d
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 672
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K854789.
CHEMISTRY CONTROL N & A
K855036 · Integrated Medical Systems Int'L., Inc. · Mar 1986
BOVINE CHEMISTRY CONTROL I.X AND II.X
K860355 · American Dade · Mar 1986
CANTROL ELECTROPHORESIS CONTROL
K854931 · Canyon Diagnostics, Inc. · Jan 1986
CRITIC - SF, ASSAYED
K854967 · Dimension Diagnostics · Jan 1986
CRITIC C LEVEL I & II
K853943 · Dimension Diagnostics · Dec 1985
ACCURACY
K854119 · Columbia Diagnostics, Inc. · Oct 1985
K854789 · RANGE-CHEK
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