Cleared Traditional

STC DIAGNOSTICS LSD MICRO-PLATE EIA (K954073) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954073 · Solarcare Technologies Corp,Inc. · Toxicology device
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Nov 1995
Decision
91d
Days
Class 2
Risk

K954073 is an FDA 510(k) clearance for the STC DIAGNOSTICS LSD MICRO-PLATE EIA. Classified as Radioimmunoassay, Lsd (125-i) (product code DLB), Class II - Special Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3580 - 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 Solarcare Technologies Corp,Inc. devices

Submission Details

510(k) Number K954073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1995
Decision Date November 29, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 87d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLB Radioimmunoassay, Lsd (125-i)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3580
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 Toxicology devices follow this clearance model.

Regulatory Peers - DLB Radioimmunoassay, Lsd (125-i)

Devices cleared under the same product code (DLB) and FDA review panel - the closest regulatory comparables to K954073.
ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
K961436 · Roche Diagnostic Systems, Inc. · Jun 1996
COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT
K891167 · Diagnostic Products Corp. · May 1989
REVISED LABELING FOR LSD TEST KIT
K874270 · Roche Diagnostic Systems, Inc. · Nov 1987
ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD
K860525 · Roche Diagnostic Systems, Inc. · Apr 1986