Cleared Traditional

K031445 - MAINLINE MAXIE HCG URINE PREGNANCY TEST

K031445 is an FDA 510(k) clearance for MAINLINE MAXIE HCG URINE PREGNANCY TEST, manufactured by Mainline Technology, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K031445 · Mainline Technology, Inc. · Chemistry device
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Jul 2003
Decision
55d
Days
Class 2
Risk

K031445 is an FDA 510(k) clearance for the MAINLINE MAXIE HCG URINE PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Mainline Technology, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on July 1, 2003 after a review of 55 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.

FDA 510(k) Submission Details - K031445

510(k) Number K031445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2003
Decision Date July 01, 2003
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 89d · This submission: 55d
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 360
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K031445.
ZAP HCG TEST, MODEL 8001
K033297 · Zbx Corporation · Mar 2004
CLINITEST HCG PREGNANCY TEST
K032563 · Bayer Healthcare, LLC · Dec 2003
ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
K032987 · Unotech Diagnostics, Inc. · Nov 2003
CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
K031048 · Access Bio Incorporate · Jun 2003
EASYCUP
K023823 · Zer Hitech · May 2003
POLY STAT SERUM/URINE HCG TEST
K030430 · Alidex, Inc. · Apr 2003
K031445 · MAINLINE MAXIE HCG URINE PREGNANCY TEST
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