Cleared Traditional

K811674 - DRUG STANDARDS

K811674 is the FDA 510(k) clearance for DRUG STANDARDS by Supelco, Inc.. It is a Class 2 Chemistry device (product code DKB) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K811674 · Supelco, Inc. · Chemistry device
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Jul 1981
Decision
30d
Days
Class 2
Risk

K811674 is an FDA 510(k) clearance for the DRUG STANDARDS. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Supelco, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 15, 1981 after a review of 30 days - a notably fast clearance cycle.

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

View all Supelco, Inc. devices

Submission Details

510(k) Number K811674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1981
Decision Date July 15, 1981
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
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. No clinical trials required.

Device Classification

Product Code DKB Calibrators, Drug Mixture
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 - DKB Calibrators, Drug Mixture

All 78
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K811674.
EMIT ST URINE METHAGUALONE CALIBRATOR
K821767 · Syva Co. · Jun 1982
EMIT-ST URINE CALIBRATOR A (#3A319
K820461 · Syva Co. · Mar 1982
CALIBRATOR SET
K820190 · Syva Co. · Feb 1982
EMIT-TOX SERUM CALIBRATORS
K811620 · Syva Co. · Jun 1981
EMIT-ST SERUM CALBRATOR
K810464 · Syva Co. · Mar 1981
EMIT-STM URINE CALIBRATORS
K802624 · Syva Co. · Nov 1980