Cleared Traditional

K151557 - EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine

K151557 is an FDA 510(k) clearance for EGENS Urine Test Cup Morphine - Methamp..., manufactured by Nantong Egens Biotech Co., Ltd.. The device is a Class 2 Toxicology device with product code DNK cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K151557 · Nantong Egens Biotech Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
36d
Days
Class 2
Risk

K151557 is an FDA 510(k) clearance for the EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine.... Classified as Thin Layer Chromatography, Morphine (product code DNK), Class II - Special Controls.

Submitted by Nantong Egens Biotech Co., Ltd. (Nantong, CN). The FDA issued a Cleared decision on July 16, 2015 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3640 - 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 Nantong Egens Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K151557

510(k) Number K151557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2015
Decision Date July 16, 2015
Days to Decision 36 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
51d faster than avg
Panel avg: 87d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DNK Device Classification - Class 2, Special Controls

Product Code DNK Thin Layer Chromatography, Morphine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3640
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 Consultant

LSI International, Inc.
JOE SHIA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.