Cleared Traditional

K122907 - FASTEP AT-HOME PREGNANCY

K122907 is the FDA 510(k) clearance for FASTEP AT-HOME PREGNANCY by Polymed Therapeutics, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K122907 · Polymed Therapeutics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
174d
Days
Class 2
Risk

K122907 is an FDA 510(k) clearance for the FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Polymed Therapeutics, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on March 14, 2013 after a review of 174 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 Polymed Therapeutics, Inc. devices

Submission Details

510(k) Number K122907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2012
Decision Date March 14, 2013
Days to Decision 174 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 88d · This submission: 174d
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 112
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K122907.
Preview Digital Pregnancy Test
K173229 · Guangzhou Wondfo Biotech Co., Ltd. · Mar 2018
ACRO HCG Pregnancy Rapid Test
K172512 · Acro Biotech, Inc. · Feb 2018
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
K150022 · Guangzhou Wondfo Biotech Co., Ltd. · Aug 2015
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · Taidoc Technology Corporation · Oct 2011
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769 · Unipath , Ltd. · Jul 2006
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K060128 · Unipath , Ltd. · May 2006