Cleared Traditional

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (K200133) - FDA 510(k) Clearance

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

K200133 · Safecare Biotech (Hangzhou) Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
205d
Days
Class 2
Risk

K200133 is an FDA 510(k) clearance for the hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 13, 2020 after a review of 205 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Safecare Biotech (Hangzhou) Co., Ltd. devices

Submission Details

510(k) Number K200133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2020
Decision Date August 13, 2020
Days to Decision 205 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 88d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 49
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K200133.
Clearblue® Early Digital Pregnancy Test
K200913 · Spd Swiss Precision Diagnostics GmbH · Aug 2021
Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)
K203246 · Atlas Link Technology Co., Ltd. · Aug 2021
Distinct® Early Detection Pregnancy Test
K193318 · ACON Laboratories, Inc. · Aug 2020
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
K193132 · Hangzhou Clongene Biotech Co., Ltd. · Dec 2019
INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
K192843 · Innovita (Tangshan) Biological Technology Co., Ltd. · Nov 2019
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
K192123 · Qingdao Hightop Biotech Co., Ltd. · Sep 2019