Cleared Traditional

K890030 - NEW LOW LEVEL DRUG MIXTURE CONTROL

K890030 is the FDA 510(k) clearance for NEW LOW LEVEL DRUG MIXTURE CONTROL by Rapid Diagnostic Laboratories, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K890030 · Rapid Diagnostic Laboratories, Inc. · Toxicology device
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Jan 1989
Decision
19d
Days
Class 1
Risk

K890030 is an FDA 510(k) clearance for the NEW LOW LEVEL DRUG MIXTURE CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Rapid Diagnostic Laboratories, Inc. (Port Washington, US). The FDA issued a Cleared decision on January 23, 1989 after a review of 19 days - a notably fast clearance cycle.

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: 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 Rapid Diagnostic Laboratories, Inc. devices

Submission Details

510(k) Number K890030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1989
Decision Date January 23, 1989
Days to Decision 19 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 87d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture 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 - DIF Drug Mixture Control Materials

All 147
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K890030.
KIT- CIBA CORNING L-TDM I, II, III
K893682 · Ciba Corning Diagnostics Corp. · Sep 1989
DAU I, DAU II, DAU III AND DAU IV CONTROL URINE
K893835 · Ciba Corning Diagnostics Corp. · Jul 1989
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:
K890957 · Hycor Biomedical, Inc. · Mar 1989
EMIT (R) HVA NEGATIVE URINE
K883210 · Syva Co. · Sep 1988
DADE TDM CONTROL
K883190 · Baxter Healthcare Corp · Sep 1988
EMIT HVA CONTROL KIT
K881944 · Syva Co. · Jul 1988