Cleared Special

K172512 - ACRO HCG Pregnancy Rapid Test

K172512 is an FDA 510(k) clearance for ACRO HCG Pregnancy Rapid Test, manufactured by Acro Biotech, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Special 510(k) pathway after a 165-day FDA review.

K172512 · Acro Biotech, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
165d
Days
Class 2
Risk

K172512 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 February 2, 2018 after a review of 165 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K172512

510(k) Number K172512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2017
Decision Date February 02, 2018
Days to Decision 165 days
Submission Type Special
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
76d slower than avg
Panel avg: 89d · This submission: 165d
Pathway characteristics
Modification to existing cleared device.

LCX Device Classification - Class 2, Special Controls

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 225
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K172512.
Acro HCG Pregnancy Rapid Test
K180771 · Acro Biotech, Inc. · May 2018
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
LIA Pregnancy Test
K171136 · Lia Diagnostics · Nov 2017
Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
K142754 · Sugentech, Inc. · Apr 2016
One Step hCG Pregnancy Test
K150063 · Coretests, Inc. · Oct 2015
K172512 · ACRO HCG Pregnancy Rapid Test
Download PDF FDA Summary Acro Biotech, Inc.