Cleared Traditional

WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (K912826) - FDA 510(k) Clearance

Class I Chemistry device.

K912826 · Cala Diagnostics · Chemistry device
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Jul 1991
Decision
30d
Days
Class 1
Risk

K912826 is an FDA 510(k) clearance for the WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2. Classified as Alcohol Control Materials (product code DKC), Class I - General Controls.

Submitted by Cala Diagnostics (Los Osos, US). The FDA issued a Cleared decision on July 26, 1991 after a review of 30 days - a notably fast clearance cycle.

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: 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 K912826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1991
Decision Date July 26, 1991
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.