Cleared Traditional

K170416 - LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators (FDA 510(k) Clearance)

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

K170416 · Lin-Zhi International, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
136d
Days
Class 2
Risk

K170416 is an FDA 510(k) clearance for the LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 an.... Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Cleared decision on June 26, 2017 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - 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 Lin-Zhi International, Inc. devices

Submission Details

510(k) Number K170416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2017
Decision Date June 26, 2017
Days to Decision 136 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
49d slower than avg
Panel avg: 87d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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.