Cleared Traditional

K810581 - FACT* HOME PREGNANCY TEST

K810581 is the FDA 510(k) clearance for FACT* HOME PREGNANCY TEST by Ortho Pharmaceutical Corp.. It is a Class 2 Chemistry device (product code JHJ) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K810581 · Ortho Pharmaceutical Corp. · Chemistry device
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Mar 1981
Decision
14d
Days
Class 2
Risk

K810581 is an FDA 510(k) clearance for the FACT* HOME PREGNANCY TEST. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Ortho Pharmaceutical Corp. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1981 after a review of 14 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 Ortho Pharmaceutical Corp. devices

Submission Details

510(k) Number K810581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1981
Decision Date March 17, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHJ Agglutination Method, Human Chorionic Gonadotropin
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 - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 43
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K810581.
ACCURATE I
K812261 · Organon, Inc. · Aug 1981
OREIA II, B-HCG
K811940 · Organon, Inc. · Aug 1981
NEOCEPT
K811941 · Organon, Inc. · Jul 1981
RAPI-DOT
K802974 · Organon, Inc. · Dec 1980
ANSWER AT-HOME PREGNANCY TEST KIT
K802660 · Armkel, LLC · Nov 1980
GESTATE SLIDE EIKEN KIT AGG. METHOD HUM
K802450 · Syn-Kit, Inc. · Oct 1980