Cleared Traditional

K102428 - WUNDER TEST

K102428 is the FDA 510(k) clearance for WUNDER TEST by Hien Helen Nguyen. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 601-day FDA review.

K102428 · Hien Helen Nguyen · Toxicology device
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Apr 2012
Decision
601d
Days
Class 2
Risk

K102428 is an FDA 510(k) clearance for the WUNDER TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Hien Helen Nguyen (San Jose, US). The FDA issued a Cleared decision on April 18, 2012 after a review of 601 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 Hien Helen Nguyen devices

Submission Details

510(k) Number K102428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2010
Decision Date April 18, 2012
Days to Decision 601 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
514d slower than avg
Panel avg: 87d · This submission: 601d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 86
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K102428.
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K110239 · Lin-Zhi International, Inc. · Jun 2011
CANNABINOIDS URINE TEST
K110182 · Guangzhou Wondfo Biotech Co., Ltd. · May 2011
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
K092269 · Randox Laboratories, Ltd. · Apr 2011