Cleared Traditional

K964574 - AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST

K964574 is an FDA 510(k) clearance for AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST, manufactured by Athena Medical Corp.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K964574 · Athena Medical Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
68d
Days
Class 2
Risk

K964574 is an FDA 510(k) clearance for the AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Athena Medical Corp. (Portland, US). The FDA issued a Cleared decision on January 21, 1997 after a review of 68 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 Athena Medical Corp. devices

FDA 510(k) Submission Details - K964574

510(k) Number K964574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1996
Decision Date January 21, 1997
Days to Decision 68 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
20d faster than avg
Panel avg: 88d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
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 - JHI Visual, Pregnancy Hcg, Prescription Use

All 251
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K964574.
ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST
K964462 · Teco Diagnostics · Feb 1997
ONE-STEP DIPSTICK PREGNANCY TEST
K964536 · Teco Diagnostics · Feb 1997
OSOM CLASSIC HCG-URINE TEST (115)
K965227 · Wyntek Diagnostics, Inc. · Feb 1997
SAS ONE-STEP PREGNANCY
K964995 · Sa Scientific, Inc. · Jan 1997
VISUALINE D HCG
K963408 · Sun Biomedical Laboratories, Inc. · Oct 1996
DSL ACTIVE I-HCG ELISA
K961911 · Diagnostic Systems Laboratories, Inc. · Jun 1996