Cleared Traditional

K850575 - DADE ALCOHOL & AMMONIA CONTROLS LEVEL I...

K850575 is the FDA 510(k) clearance for DADE ALCOHOL & AMMONIA CONTROLS LEVEL I... by American Dade. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K850575 · American Dade · Chemistry device
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Apr 1985
Decision
56d
Days
Class 1
Risk

K850575 is an FDA 510(k) clearance for the DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on April 10, 1985 after a review of 56 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 American Dade devices

Submission Details

510(k) Number K850575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1985
Decision Date April 10, 1985
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
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 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K850575.
DC-LIP, CATALOGUE NUMBER SE-020
K852594 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1985
COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY
K851942 · Coulter Electronics, Inc. · May 1985
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO
K850574 · 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