Cleared Traditional

K123844 - CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST

K123844 is an FDA 510(k) clearance for CHEMTRUE HCG PREGNANCY URINE DIPSTICK, manufactured by Chemtron Biotech, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K123844 · Chemtron Biotech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
168d
Days
Class 2
Risk

K123844 is an FDA 510(k) clearance for the CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AN.... Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Chemtron Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on May 30, 2013 after a review of 168 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 Chemtron Biotech, Inc. devices

FDA 510(k) Submission Details - K123844

510(k) Number K123844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2012
Decision Date May 30, 2013
Days to Decision 168 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
80d slower than avg
Panel avg: 88d · This submission: 168d
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 302
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K123844.
WUNDER PREGNANCY TEST
K130456 · James Nguyen · Apr 2014
FASTEP S10 HCG SERUM/URINE COMBO TEST
K132834 · Polymed Therapeutics, Inc. · Jan 2014
SOFIA(R) HCG FIA
K131166 · Quidel Corp. · Aug 2013
FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
K112101 · Polymed Therapeutics, Inc. · Jul 2012
HOME PREGNANCY TEST
K112315 · Newscen Coast Bio-Pharmaceutical Co., Ltd. · Apr 2012
RAPIDVUE HCG TEST
K102175 · Quidel Corporation · Aug 2010