Cleared Traditional

K963231 - EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST

K963231 is an FDA 510(k) clearance for EXCEL ONESTEP URINE HCG MODULE PREGNANC..., manufactured by Excel Scientific, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K963231 · Excel Scientific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
107d
Days
Class 2
Risk

K963231 is an FDA 510(k) clearance for the EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Excel Scientific, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on December 4, 1996 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Excel Scientific, Inc. devices

FDA 510(k) Submission Details - K963231

510(k) Number K963231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1996
Decision Date December 04, 1996
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 88d · This submission: 107d
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 252
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K963231.
OSOM CLASSIC HCG-URINE TEST (115)
K965227 · Wyntek Diagnostics, Inc. · Feb 1997
AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST
K964574 · Athena Medical Corp. · Jan 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
DSL ACTIVE I-HCG IRMA
K960357 · Diagnostic Systems Laboratories, Inc. · May 1996