Cleared Traditional

K971286 - EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST

K971286 is an FDA 510(k) clearance for EZ SURE (EXCEL) URINE MIDSTREAM PREGNAN..., 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 31-day FDA review.

K971286 · Excel Scientific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
31d
Days
Class 2
Risk

K971286 is an FDA 510(k) clearance for the EZ SURE (EXCEL) URINE MIDSTREAM 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 May 8, 1997 after a review of 31 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 - K971286

510(k) Number K971286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1997
Decision Date May 08, 1997
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 K971286.
BRAND NAME *1-STEP PREGNANCY
K973352 · Armkel, LLC · Oct 1997
FIRST SIGN
K973208 · Texas Immunology, Inc. · Oct 1997
QUICKSTICK ONE STEP HCG PREGNANCY TEST
K972682 · Phamatech · Aug 1997
EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
K970425 · Excel Scientific, Inc. · Mar 1997
ADVANCED QUALITY PREGNANCY TEST
K970008 · Bionike, Inc. · Feb 1997
PERFECTA PREGNANCY TEST
K965184 · Wyntek Diagnostics, Inc. · Feb 1997