Cleared Traditional

EPISCREEN ORAL SPECIMEN COLLECTION DEVICE (K973395) - FDA 510(k) Clearance

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

K973395 · Epitope, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
176d
Days
Class 2
Risk

K973395 is an FDA 510(k) clearance for the EPISCREEN ORAL SPECIMEN COLLECTION DEVICE. Classified as Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (product code PJD), Class II - Special Controls.

Submitted by Epitope, Inc. (Beaverton, US). The FDA issued a Cleared decision on February 13, 1998 after a review of 176 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Epitope, Inc. devices

Submission Details

510(k) Number K973395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1997
Decision Date February 13, 1998
Days to Decision 176 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 88d · This submission: 176d
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 Chemistry devices follow this clearance model.

Regulatory Peers - PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

All 8
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