Cleared Traditional

K954073 - STC DIAGNOSTICS LSD MICRO-PLATE EIA

K954073 is an FDA 510(k) clearance for STC DIAGNOSTICS LSD MICRO-PLATE EIA, manufactured by Solarcare Technologies Corp,Inc.. The device is a Class 2 Toxicology device with product code DLB cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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

FDA 510(k) Submission Details - K954073

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
Combination Product No
PCCP Authorized No
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.

DLB Device Classification - Class 2, Special Controls

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
EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS
K955448 · Behring Diagnostics, Inc. · Feb 1996
CEDIA DAU LSD ASSAY
K955814 · Microgenics Corp. · Feb 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