Cleared Traditional

K970425 - EZ SURE URINE DIPSTICK PREGNANCY HOME TEST

K970425 is an FDA 510(k) clearance for EZ SURE URINE DIPSTICK PREGNANCY HOME TEST, manufactured by Excel Scientific, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K970425 · Excel Scientific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
30d
Days
Class 2
Risk

K970425 is an FDA 510(k) clearance for the EZ SURE URINE DIPSTICK PREGNANCY HOME TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Excel Scientific, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on March 6, 1997 after a review of 30 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 Excel Scientific, Inc. devices

FDA 510(k) Submission Details - K970425

510(k) Number K970425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1997
Decision Date March 06, 1997
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

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 135
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K970425.
FIRST SIGN
K973208 · Texas Immunology, Inc. · Oct 1997
QUICKSTICK ONE STEP HCG PREGNANCY TEST
K972682 · Phamatech · Aug 1997
EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST
K971286 · Excel Scientific, Inc. · May 1997
ADVANCED QUALITY PREGNANCY TEST
K970008 · Bionike, Inc. · Feb 1997
PERFECTA PREGNANCY TEST
K965184 · Wyntek Diagnostics, Inc. · Feb 1997
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
K970082 · Abbott Laboratories · Jan 1997