Cleared Traditional

K011057 - INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX (FDA 510(k) Clearance)

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

K011057 · OraSure Technologies, Inc. · Toxicology device
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Jun 2001
Decision
61d
Days
Class 2
Risk

K011057 is an FDA 510(k) clearance for the INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX. Classified as Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (product code PJD), Class II - Special Controls.

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1675 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all OraSure Technologies, Inc. devices

Submission Details

510(k) Number K011057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2001
Decision Date June 06, 2001
Days to Decision 61 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
26d faster than avg
Panel avg: 87d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
Definition Intended For Use In The Collection, Preservation, And Transport Of Oral Fluid Specimens For Drugs Of Abuse Or Alcohol Testing.
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.