Cleared Traditional

K180771 - Acro HCG Pregnancy Rapid Test

K180771 is the FDA 510(k) clearance for Acro HCG Pregnancy Rapid Test by Acro Biotech, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K180771 · Acro Biotech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
56d
Days
Class 2
Risk

K180771 is an FDA 510(k) clearance for the Acro HCG Pregnancy Rapid Test. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Acro Biotech, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on May 18, 2018 after a review of 56 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.

View all Acro Biotech, Inc. devices

Submission Details

510(k) Number K180771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2018
Decision Date May 18, 2018
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
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 Consultant

Ivdd Regulatory Consultant
Feng-Yu Lee

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 - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 106
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K180771.
WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream
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Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
K183097 · Weihai Kangzhou Biotechnology Engineering Co., Ltd. · Jan 2019
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
K172627 · Runbio Biotech Co.,Ltd · Mar 2018
Preview Digital Pregnancy Test
K173229 · Guangzhou Wondfo Biotech Co., Ltd. · Mar 2018
ACRO HCG Pregnancy Rapid Test
K172512 · Acro Biotech, Inc. · Feb 2018