Cleared Traditional

K973750 - STC CANNABINOIDS MICRO-PLATE EIA

K973750 is an FDA 510(k) clearance for STC CANNABINOIDS MICRO-PLATE EIA, manufactured by OraSure Technologies, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K973750 · OraSure Technologies, Inc. · Toxicology device
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Feb 1998
Decision
135d
Days
Class 2
Risk

K973750 is an FDA 510(k) clearance for the STC CANNABINOIDS MICRO-PLATE EIA. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on February 13, 1998 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 OraSure Technologies, Inc. devices

FDA 510(k) Submission Details - K973750

510(k) Number K973750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1997
Decision Date February 13, 1998
Days to Decision 135 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
48d slower than avg
Panel avg: 87d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDJ Device Classification - Class 2, Special Controls

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 124
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K973750.
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