Cleared Traditional

K221871 - Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx (FDA 510(k) Clearance)

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

K221871 · Healstone Biotech, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Aug 2022
Decision
63d
Days
Class 2
Risk

K221871 is an FDA 510(k) clearance for the Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM).... Classified as Test, Amphetamine, Over The Counter (product code NFT), Class II - Special Controls.

Submitted by Healstone Biotech, Inc. (Vancouver, CA). The FDA issued a Cleared decision on August 30, 2022 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Healstone Biotech, Inc. devices

Submission Details

510(k) Number K221871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2022
Decision Date August 30, 2022
Days to Decision 63 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
24d faster than avg
Panel avg: 87d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFT Test, Amphetamine, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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.

Regulatory Peers - NFT Test, Amphetamine, Over The Counter

All 28
Devices cleared under the same product code (NFT) and FDA review panel - the closest regulatory comparables to K221871.
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