Cleared Traditional

K001976 - STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I (FDA 510(k) Clearance)

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

K001976 · OraSure Technologies, Inc. · Toxicology device
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Dec 2000
Decision
160d
Days
Class 2
Risk

K001976 is an FDA 510(k) clearance for the STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on December 6, 2000 after a review of 160 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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

Submission Details

510(k) Number K001976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2000
Decision Date December 06, 2000
Days to Decision 160 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 87d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 99
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K001976.
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