Cleared Traditional

K933425 - AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812

K933425 is an FDA 510(k) clearance for AMMONIA/ETHANOL CONTROLS, manufactured by Sigma Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code DKC cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K933425 · Sigma Diagnostics, Inc. · Chemistry device
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Nov 1993
Decision
126d
Days
Class 1
Risk

K933425 is an FDA 510(k) clearance for the AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812. Classified as Alcohol Control Materials (product code DKC), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 16, 1993 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K933425

510(k) Number K933425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1993
Decision Date November 16, 1993
Days to Decision 126 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 89d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

DKC Device Classification - Class 1, General Controls

Product Code DKC Alcohol Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - DKC Alcohol Control Materials

All 10
Devices cleared under the same product code (DKC) and FDA review panel - the closest regulatory comparables to K933425.
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
K031392 · Medical Analysis Systems, Inc. · Jul 2003
QUALITY CONTROL MATERIAL (ASSAYED)
K935819 · Columbia Diagnostics, Inc. · Mar 1994
BECKMAN CX AMMONIA/ALCOHOL CONTROL
K934467 · Beckman-Diagnostic Systems Group · Oct 1993
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
K932067 · Sigma Diagnostics, Inc. · Jun 1993
SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3
K912827 · Cala Diagnostics · Aug 1991
WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2
K912826 · Cala Diagnostics · Jul 1991
K933425 · AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
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