Cleared Traditional

K143535 - CR3 Keyless Split Sample Cup Secobarbital- Methadone (FDA 510(k) Clearance)

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

K143535 · Guangzhou Wondfo Biotech Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
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Jan 2015
Decision
29d
Days
Class 2
Risk

K143535 is an FDA 510(k) clearance for the CR3 Keyless Split Sample Cup Secobarbital- Methadone. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on January 13, 2015 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3150 - the FDA in vitro diagnostics and chemistry 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 Guangzhou Wondfo Biotech Co., Ltd. devices

Submission Details

510(k) Number K143535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2014
Decision Date January 13, 2015
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 Chemistry devices follow this clearance model.

Regulatory Peers - DIS Enzyme Immunoassay, Barbiturate

All 99
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K143535.
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K161714 · Immunalysis Corporation · Oct 2016
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
K150791 · Healgen Scientific, LLC · Apr 2015