Cleared Traditional

K132834 - FASTEP S10 HCG SERUM/URINE COMBO TEST

K132834 is an FDA 510(k) clearance for FASTEP S10 HCG SERUM/URINE COMBO TEST, manufactured by Polymed Therapeutics, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K132834 · Polymed Therapeutics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
121d
Days
Class 2
Risk

K132834 is an FDA 510(k) clearance for the FASTEP S10 HCG SERUM/URINE COMBO TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Polymed Therapeutics, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on January 9, 2014 after a review of 121 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K132834

510(k) Number K132834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2013
Decision Date January 09, 2014
Days to Decision 121 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
33d slower than avg
Panel avg: 88d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
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 - JHI Visual, Pregnancy Hcg, Prescription Use

All 286
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K132834.
TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
K172257 · True Diagnostics, Inc. · Dec 2017
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
K152768 · Assure Tech. Co., Ltd. · Feb 2016
WUNDER PREGNANCY TEST
K130456 · James Nguyen · Apr 2014
SOFIA(R) HCG FIA
K131166 · Quidel Corp. · Aug 2013
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
K123844 · Chemtron Biotech, Inc. · May 2013
FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
K112101 · Polymed Therapeutics, Inc. · Jul 2012