Cleared Traditional

K172910 - Emit II Plus Oxycodone Assay

K172910 is the FDA 510(k) clearance for Emit II Plus Oxycodone Assay by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K172910 · Siemens Healthcare Diagnostics, Inc. · Toxicology device
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Oct 2017
Decision
23d
Days
Class 2
Risk

K172910 is an FDA 510(k) clearance for the Emit II Plus Oxycodone Assay. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on October 18, 2017 after a review of 23 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K172910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2017
Decision Date October 18, 2017
Days to Decision 23 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
64d faster than avg
Panel avg: 87d · This submission: 23d
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 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K172910.
Synermed Opiate Enzyme Immunoassay
K172416 · Infrared Laboratory Systems, LLC (Dba Synermed) · Apr 2018
DRI Hydrocodone Assay
K173195 · Microgenics Corporation · Feb 2018
CEDIA Heroin Metabolite (6-AM) Assay
K173183 · Microgenics Corporation · Nov 2017
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
K161216 · Immunalysis Corporation · Jun 2017
CEDIA Buprenorphine II Assay
K163101 · Microgenics Corporation · Apr 2017
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
K150606 · Siemens Healthcare Diagnostics, Inc. · Oct 2015