Cleared Traditional

K951817 - ELI URINE CONTROLS

K951817 is an FDA 510(k) clearance for ELI URINE CONTROLS, manufactured by Elsohly Labs, Inc.. The device is a Class 1 Chemistry device with product code DIF cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K951817 · Elsohly Labs, Inc. · Chemistry device
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Jun 1995
Decision
60d
Days
Class 1
Risk

K951817 is an FDA 510(k) clearance for the ELI URINE CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Elsohly Labs, Inc. (Oxford, US). The FDA issued a Cleared decision on June 19, 1995 after a review of 60 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.

View all Elsohly Labs, Inc. devices

FDA 510(k) Submission Details - K951817

510(k) Number K951817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1995
Decision Date June 19, 1995
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

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 177
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K951817.
ABUSCREEN ONLINE CONTROLS
K953739 · Roche Diagnostic Systems, Inc. · Sep 1995
ABUSCREEN ONLINE DRUG FREE URINE
K953845 · Roche Diagnostic Systems, Inc. · Sep 1995
DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL
K952412 · Dupont Medical Products · Jun 1995
IMMUNOASSAY DRUGS OF ABUSE CONTROLS
K952056 · Medi-Tech, Inc. · Jun 1995
MULTI-DRUG CONTROL SET
K951135 · Microgenics Corp. · Apr 1995
DRUGS OF ABUSE CONTROLS
K950138 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995