Cleared Traditional

K935819 - QUALITY CONTROL MATERIAL (ASSAYED)

K935819 is the FDA 510(k) clearance for QUALITY CONTROL MATERIAL (ASSAYED) by Columbia Diagnostics, Inc.. It is a Class 1 Toxicology device (product code DKC) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K935819 · Columbia Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
109d
Days
Class 1
Risk

K935819 is an FDA 510(k) clearance for the QUALITY CONTROL MATERIAL (ASSAYED). Classified as Alcohol Control Materials (product code DKC), Class I - General Controls.

Submitted by Columbia Diagnostics, Inc. (Springfield, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Columbia Diagnostics, Inc. devices

Submission Details

510(k) Number K935819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1993
Decision Date March 22, 1994
Days to Decision 109 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 87d · This submission: 109d
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.

Regulatory Peers - DKC Alcohol Control Materials

Devices cleared under the same product code (DKC) and FDA review panel - the closest regulatory comparables to K935819.
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
K031392 · Medical Analysis Systems, Inc. · Jul 2003
AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
K933425 · Sigma Diagnostics, Inc. · Nov 1993
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
K932067 · Sigma Diagnostics, Inc. · Jun 1993
ETHANOL CONTROLS LOW & HIGH E5133/E5258
K843872 · Sigma Chemical Co. · Oct 1984
EMIT-ST ETHYL ALCOHOL SERUM CONTROLS
K810465 · Syva Co. · Mar 1981
EMIT-STM ETHYL ALCOHOL URINE CONTROLS
K802618 · Syva Co. · Oct 1980