Cleared Traditional

CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST (K131931) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131931 · Chemtron Biotech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
29d
Days
Class 2
Risk

K131931 is an FDA 510(k) clearance for the CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Chemtron Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 26, 2013 after a review of 29 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 Chemtron Biotech, Inc. devices

Submission Details

510(k) Number K131931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2013
Decision Date July 26, 2013
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
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 50
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K131931.
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
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Preview Digital Pregnancy Test
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ACRO HCG Pregnancy Rapid Test
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FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · Taidoc Technology Corporation · Oct 2011
SAS HCG-CHECK
K991193 · Sa Scientific, Inc. · May 1999
FACT PLUS ONE STEP PREGNANCY TEST
K990373 · Abbott Laboratories · Feb 1999