Cleared Traditional

K222955 - Xenta Drug Screen Cup

K222955 is an FDA 510(k) clearance for Xenta Drug Screen Cup, manufactured by Xenta Biomedical Science Co., Ltd.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K222955 · Xenta Biomedical Science Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
132d
Days
Class 2
Risk

K222955 is an FDA 510(k) clearance for the Xenta Drug Screen Cup, Xenta Drug Screen Dipcard. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Xenta Biomedical Science Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 6, 2023 after a review of 132 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 Xenta Biomedical Science Co., Ltd. devices

FDA 510(k) Submission Details - K222955

510(k) Number K222955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2022
Decision Date February 06, 2023
Days to Decision 132 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
45d slower than avg
Panel avg: 87d · This submission: 132d
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 150
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K222955.
AllTest Fentanyl Rapid Test (Urine)
K231698 · Hangzhou AllTest Biotech Co., Ltd. · Jul 2023
Emit® II Plus Buprenorphine Assay
K221605 · Siemens Healthcare Diagnostics, Inc. · Jul 2023
BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx
K230238 · Shenzhen Bioeasy Biotechnology Co., Ltd. · Mar 2023
Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
K220046 · Shenzhen Superbio Technology Co., Ltd. · Dec 2022
Immunalysis Tapentadol Urine HEIA
K203527 · Lmmunalysis Corporation · May 2022
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
K203564 · Immunalysis Corporation · Dec 2021