Cleared Traditional

K161714 - Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

K161714 is an FDA 510(k) clearance for Immunalysis Barbiturates Urine Enzyme I..., manufactured by Immunalysis Corporation. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K161714 · Immunalysis Corporation · Toxicology device
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Oct 2016
Decision
115d
Days
Class 2
Risk

K161714 is an FDA 510(k) clearance for the Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal.... Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on October 14, 2016 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunalysis Corporation devices

FDA 510(k) Submission Details - K161714

510(k) Number K161714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2016
Decision Date October 14, 2016
Days to Decision 115 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 87d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIS Device Classification - Class 2, Special Controls

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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.

Regulatory Peers - DIS Enzyme Immunoassay, Barbiturate

All 89
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