Cleared Traditional

SALIVA SAMPLER (K942435) - FDA 510(k) Clearance

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

K942435 · Saliva Diagnostic Systems, Inc. · Microbiology device
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Aug 1995
Decision
458d
Days
Class 2
Risk

K942435 is an FDA 510(k) clearance for the SALIVA SAMPLER. Classified as Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (product code PJD), Class II - Special Controls.

Submitted by Saliva Diagnostic Systems, Inc. (Vancouver, US). The FDA issued a Cleared decision on August 21, 1995 after a review of 458 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Saliva Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K942435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1994
Decision Date August 21, 1995
Days to Decision 458 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
356d slower than avg
Panel avg: 102d · This submission: 458d
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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