Cleared Traditional

K914254 - HOMECLINIC ONE STEP PREGNANCY TEST

K914254 is an FDA 510(k) clearance for HOMECLINIC ONE STEP PREGNANCY TEST, manufactured by Vanguard Biomedical Corp.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K914254 · Vanguard Biomedical Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
24d
Days
Class 2
Risk

K914254 is an FDA 510(k) clearance for the HOMECLINIC ONE STEP PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Vanguard Biomedical Corp. (San Diego, US). The FDA issued a Cleared decision on October 17, 1991 after a review of 24 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 - K914254

510(k) Number K914254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1991
Decision Date October 17, 1991
Days to Decision 24 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
65d faster than avg
Panel avg: 89d · This submission: 24d
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 225
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K914254.
SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST
K921099 · Syntron Bioresearch, Inc. · May 1992
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
K921012 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
ADVANCE(R) PREGNANCY TEST
K914990 · Ortho Pharmaceutical Corp. · Dec 1991
FIRST RESPONSE(R) ONE-STEP
K914304 · Armkel, LLC · Oct 1991
QUIKPAC-II ONE STEP PREGNANCY HOME TEST
K912316 · Syntron Bioresearch, Inc. · Jul 1991
CLEARBLUE EASY
K911566 · Unipath , Ltd. · May 1991
K914254 · HOMECLINIC ONE STEP PREGNANCY TEST
Download PDF FDA Summary Vanguard Biomedical C…