Cleared Traditional

STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION (K940048) - FDA 510(k) Clearance

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

K940048 · Solarcare Technologies Corp,Inc. · Toxicology device
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Mar 1996
Decision
804d
Days
Class 2
Risk

K940048 is an FDA 510(k) clearance for the STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on March 19, 1996 after a review of 804 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Solarcare Technologies Corp,Inc. devices

Submission Details

510(k) Number K940048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1994
Decision Date March 19, 1996
Days to Decision 804 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
717d slower than avg
Panel avg: 87d · This submission: 804d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
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 Toxicology devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 122
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K053108 · Dade Behring, Inc. · Feb 2006
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
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