Cleared Traditional

K970424 - EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST

K970424 is an FDA 510(k) clearance for EXCEL ONE STEP URINE HCG PREGNANCY DIPS..., 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 30-day FDA review.

K970424 · Excel Scientific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
30d
Days
Class 2
Risk

K970424 is an FDA 510(k) clearance for the EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK 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 March 6, 1997 after a review of 30 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 Excel Scientific, Inc. devices

FDA 510(k) Submission Details - K970424

510(k) Number K970424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1997
Decision Date March 06, 1997
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
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 K970424.
ACCUTEST HCG-URINE
K971886 · Unotech Diagnostics, Inc. · Jun 1997
ACCULINE PREGNANCY TEST
K971122 · Genix Biotek, Inc. · Apr 1997
CLINITEK HCG TEST STRIPS
K971209 · Bayer Corp. · Apr 1997
ACCUPACK PREGNANCY TEST
K964633 · Genix Biotek, Inc. · Feb 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116 · Abbott Laboratories · Feb 1997
SAS SERUM/URINE HCG
K965250 · Sascie · Feb 1997