Cleared Traditional

K190705 - WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream (FDA 510(k) Clearance)

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

K190705 · Wholepower Biotech Co., Ltd. · Chemistry device
Apr 2019
Decision
27d
Days
Class 2
Risk

K190705 is an FDA 510(k) clearance for the WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Str.... Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Wholepower Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on April 15, 2019 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K190705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2019
Decision Date April 15, 2019
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
207d faster than avg
Panel avg: 234d · This submission: 27d
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

Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K190705.
MissLan® Early Detection Digital Pregnancy Test
K251040 · Guangzhou Decheng Biotechnology Co., Ltd. · Sep 2025
Shinetell PlusTM Digital Early Pregnancy Test
K251053 · Hangzhou AllTest Biotech Co., Ltd. · Jul 2025
iHealth® Early Pregnancy Test
K241394 · Andon Health Co, Ltd. · Dec 2024
Distinct® Digital Pregnancy Test
K232715 · ACON Laboratories, Inc. · May 2024