Cleared Traditional

K925096 - CONCEIVE ONE-STEP PREGNANCY TEST

K925096 is the FDA 510(k) clearance for CONCEIVE ONE-STEP PREGNANCY TEST by Quidel Corp.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K925096 · Quidel Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
81d
Days
Class 2
Risk

K925096 is an FDA 510(k) clearance for the CONCEIVE ONE-STEP PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on December 28, 1992 after a review of 81 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 Quidel Corp. devices

Submission Details

510(k) Number K925096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1992
Decision Date December 28, 1992
Days to Decision 81 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
7d faster than avg
Panel avg: 88d · This submission: 81d
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 98
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K925096.
PREGNANCY CHECK
K941355 · Sa Scientific, Inc. · Jul 1994
PREDICTOR HOME PREGNANCY TEST
K940637 · Organon Teknika Corp. · Jun 1994
PRECISE PREGNANCY
K930640 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
K921012 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
FIRST RESPONSE(R) ONE-STEP
K914304 · Armkel, LLC · Oct 1991
CLEARBLUE EASY
K911566 · Unipath , Ltd. · May 1991