Cleared Traditional

K201494 - ATTEST Drug Screen Cup

K201494 is an FDA 510(k) clearance for ATTEST Drug Screen Cup, manufactured by Advin Biotech, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K201494 · Advin Biotech, Inc. · Toxicology device
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Sep 2020
Decision
104d
Days
Class 2
Risk

K201494 is an FDA 510(k) clearance for the ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Advin Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on September 17, 2020 after a review of 104 days - within the typical 510(k) review window.

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: 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 Advin Biotech, Inc. devices

FDA 510(k) Submission Details - K201494

510(k) Number K201494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2020
Decision Date September 17, 2020
Days to Decision 104 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 87d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

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 149
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K201494.
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
K203564 · Immunalysis Corporation · Dec 2021
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
K201630 · Assure Tech. (Hangzhou) Co, Ltd. · Aug 2021
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
K201326 · Psychemedics Corporation · Jul 2021
LZI Oxycodone III Enzyme Immunoassay
K202007 · Lin-Zhi International, Inc. · Sep 2020
LZI Fentanyl II Enzyme Immunoassay
K201938 · Lin-Zhi International, Inc. · Aug 2020
LZI Tramadol Enzyme Immunoassay
K201223 · Lin-Zhi International, Inc. · Jun 2020