Cleared Traditional

K161216 - Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators (FDA 510(k) Clearance)

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

K161216 · Immunalysis Corporation · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
411d
Days
Class 2
Risk

K161216 is an FDA 510(k) clearance for the Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Ur.... Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on June 14, 2017 after a review of 411 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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: 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 Toxicology submissions.

View all Immunalysis Corporation devices

Submission Details

510(k) Number K161216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2016
Decision Date June 14, 2017
Days to Decision 411 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
324d slower than avg
Panel avg: 87d · This submission: 411d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 214
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K161216.
Labcorp Fentanyl Urine Visual Test
K252684 · Medtox Diagnostics, Inc. · Jan 2026
Evidence MultiSTAT DOA Urine MultiPlex
K250741 · Randox Laboratories Limited · Jan 2026
LZI Buprenorphine II Enzyme Immunoassay
K253082 · Lin-Zhi International, Inc. · Jan 2026
SEFRIA™ Hydrocodone Oral Fluid
K252520 · Immunalysis Corporation · Sep 2025
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative
K251972 · Healgen Scientific, LLC · Aug 2025
LZI Fentanyl III Enzyme Immunoassay
K251634 · Lin-Zhi International, Inc. · Jun 2025