Cleared Traditional

K955707 - ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT

K955707 is an FDA 510(k) clearance for ONESTEP URINE/SERUM HCG MODULE PREGNANC..., manufactured by Excel Scientific, Inc.. The device is a Class 2 Chemistry device with product code DHA cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K955707 · Excel Scientific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
139d
Days
Class 2
Risk

K955707 is an FDA 510(k) clearance for the ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Excel Scientific, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on May 2, 1996 after a review of 139 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 - K955707

510(k) Number K955707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1995
Decision Date May 02, 1996
Days to Decision 139 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
51d slower than avg
Panel avg: 88d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHA Device Classification - Class 2, Special Controls

Product Code DHA System, Test, 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 - DHA System, Test, Human Chorionic Gonadotropin

All 50
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K955707.
HUMAN CHORIONIC GONADOTROPIN METHOD
K970387 · Dade Chemistry Systems, Inc. · Mar 1997
ELECSYS HCG ASSAY
K961487 · Boehringer Mannheim Corp. · Jun 1996
HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD
K961351 · Bayer Corp. · Jun 1996
AMERLITE HCG-60 ASSAY
K952283 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995
AURAFLEX HCG
K945331 · Organon Teknika Corp. · Mar 1995
BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST
K950307 · Princeton BioMeditech Corp. · Mar 1995