Cleared Traditional

K191924 - SAFECARE THC Urine Strip Test

K191924 is an FDA 510(k) clearance for SAFECARE THC Urine Strip Test, manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. The device is a Class 2 Toxicology device with product code NFW cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K191924 · Safecare Biotech (Hangzhou) Co., Ltd. · Toxicology device
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Aug 2019
Decision
29d
Days
Class 2
Risk

K191924 is an FDA 510(k) clearance for the SAFECARE® THC Urine Strip Test. Classified as Test, Cannabinoid, Over The Counter (product code NFW), Class II - Special Controls.

Submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 16, 2019 after a review of 29 days - a notably fast clearance cycle.

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: 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 Safecare Biotech (Hangzhou) Co., Ltd. devices

FDA 510(k) Submission Details - K191924

510(k) Number K191924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2019
Decision Date August 16, 2019
Days to Decision 29 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
58d faster than avg
Panel avg: 87d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFW Device Classification - Class 2, Special Controls

Product Code NFW Test, Cannabinoid, Over The Counter
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 Consultant

Lsi International
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.