Cleared Traditional

EPISCREEN (K970357) - FDA 510(k) Clearance

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

K970357 · Epitope, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Mar 1997
Decision
39d
Days
Class 2
Risk

K970357 is an FDA 510(k) clearance for the EPISCREEN. 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 March 10, 1997 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1675 - the FDA microbiology 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 Epitope, Inc. devices

Submission Details

510(k) Number K970357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1997
Decision Date March 10, 1997
Days to Decision 39 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 102d · This submission: 39d
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 Microbiology 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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