Cleared Traditional

K853532 - ALCOHOL CALIBRATORS

K853532 is the FDA 510(k) clearance for ALCOHOL CALIBRATORS by Diagnostic Systems. It is a Class 2 Chemistry device (product code DNN) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K853532 · Diagnostic Systems · Chemistry device
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Sep 1985
Decision
24d
Days
Class 2
Risk

K853532 is an FDA 510(k) clearance for the ALCOHOL CALIBRATORS. Classified as Calibrators, Ethyl Alcohol (product code DNN), Class II - Special Controls.

Submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on September 16, 1985 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3200 - 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.

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Submission Details

510(k) Number K853532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1985
Decision Date September 16, 1985
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DNN Calibrators, Ethyl Alcohol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - DNN Calibrators, Ethyl Alcohol

Devices cleared under the same product code (DNN) and FDA review panel - the closest regulatory comparables to K853532.
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K990516 · Emd Chemicals, Inc. · Mar 1999
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K973054 · Emd Chemicals, Inc. · Oct 1997
ETHYL ALCOHOL CALIBRATORS & CONTROL
K924733 · Diagnostic Reagents, Inc. · Dec 1992
ETHYL ALCOHOL SERUM CALIBRATOR
K810466 · Syva Co. · Mar 1981
EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR
K802620 · Syva Co. · Oct 1980