Cleared Traditional

K962521 - FACTPLUS ONE STEP PREGNANCY TEST

K962521 is an FDA 510(k) clearance for FACTPLUS ONE STEP PREGNANCY TEST, manufactured by Direct Access Diagnostics. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K962521 · Direct Access Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
40d
Days
Class 2
Risk

K962521 is an FDA 510(k) clearance for the FACTPLUS ONE STEP PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Direct Access Diagnostics (Bridgewater, US). The FDA issued a Cleared decision on July 29, 1996 after a review of 40 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 Direct Access Diagnostics devices

FDA 510(k) Submission Details - K962521

510(k) Number K962521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1996
Decision Date July 29, 1996
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
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 153
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K962521.
EVIDENCE PREGNANCY TEST
K962721 · Saliva Diagnostic Systems · Oct 1996
AFFIRM ONE-STEP HOME PREGNANCY TEST
K962888 · Athena Medical Corp. · Sep 1996
EZ SURE ONESTEP EARLY PREGNANCY TEST
K962580 · Excel Scientific, Inc. · Aug 1996
QUICKSTICK ONE STEP PREGNANCY TEST(9010)
K962219 · Phamatech · Jul 1996
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
K962183 · Armkel, LLC · Jul 1996
SURE CHECK PREGNANCY TEST
K961965 · Chembio Diagnostic Systems, Inc. · Jun 1996