Cleared Traditional

K151771 - Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (FDA 510(k) Clearance)

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

K151771 · Immunalysis Corporation · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
189d
Days
Class 2
Risk

K151771 is an FDA 510(k) clearance for the Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug .... Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on January 5, 2016 after a review of 189 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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

Submission Details

510(k) Number K151771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2015
Decision Date January 05, 2016
Days to Decision 189 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
102d slower than avg
Panel avg: 87d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 89
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K151771.
Alinity c Benzodiazepines Reagent Kit
K243498 · Microgenics Corporation · Dec 2024
ONLINE DAT Benzodiazepines II
K221765 · Roche Diagnostics · Dec 2022
CEDIA Benzodiazepine Assay
K190968 · Microgenics Corporation · Dec 2019
DRI Benzodiazepine Assay
K173963 · Microgenics Corporation · Feb 2018
Healgen Multi-Drug Urine Test Cup
K163704 · Healgen Scientific, LLC · Aug 2017
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K153597 · Healgen Scientific, LLC · May 2016