Cleared Traditional

Quantisal Oral Fluid Collection Device (K200801) - FDA 510(k) Clearance

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

K200801 · Immunalysis Corporation · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 2020
Decision
123d
Days
Class 2
Risk

K200801 is an FDA 510(k) clearance for the Quantisal Oral Fluid Collection Device. Classified as Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (product code PJD), Class II - Special Controls.

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on July 28, 2020 after a review of 123 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K200801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2020
Decision Date July 28, 2020
Days to Decision 123 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 88d · This submission: 123d
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.