Cleared Traditional

K962888 - AFFIRM ONE-STEP HOME PREGNANCY TEST

K962888 is an FDA 510(k) clearance for AFFIRM ONE-STEP HOME PREGNANCY TEST, manufactured by Athena Medical Corp.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K962888 · Athena Medical Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
61d
Days
Class 2
Risk

K962888 is an FDA 510(k) clearance for the AFFIRM ONE-STEP HOME PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Athena Medical Corp. (Portland, US). The FDA issued a Cleared decision on September 23, 1996 after a review of 61 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 - K962888

510(k) Number K962888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1996
Decision Date September 23, 1996
Days to Decision 61 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
27d faster than avg
Panel avg: 88d · This submission: 61d
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 202
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K962888.
FACT PLUS PREGNANCY TEST
K964108 · Direct Access Diagnostics · Nov 1996
NATURALE HCG PREGNANCY TES
K964002 · Mizuho USA, Inc. · Nov 1996
EVIDENCE PREGNANCY TEST
K962721 · Saliva Diagnostic Systems · Oct 1996
EZ SURE ONESTEP EARLY PREGNANCY TEST
K962580 · Excel Scientific, Inc. · Aug 1996
FACTPLUS ONE STEP PREGNANCY TEST
K962521 · Direct Access Diagnostics · Jul 1996
QUICKSTICK ONE STEP PREGNANCY TEST(9010)
K962219 · Phamatech · Jul 1996
K962888 · AFFIRM ONE-STEP HOME PREGNANCY TEST
Download PDF FDA Summary Athena Medical Corp.