Cleared Traditional

K963341 - MIDSTREAM ONESTEP PREGNANCY HOME TEST

K963341 is the FDA 510(k) clearance for MIDSTREAM ONESTEP PREGNANCY HOME TEST by Syntron Bioresearch, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K963341 · Syntron Bioresearch, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
98d
Days
Class 2
Risk

K963341 is an FDA 510(k) clearance for the MIDSTREAM ONESTEP PREGNANCY HOME TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Syntron Bioresearch, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 2, 1996 after a review of 98 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 Syntron Bioresearch, Inc. devices

Submission Details

510(k) Number K963341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1996
Decision Date December 02, 1996
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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 - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 112
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K963341.
BRAND NAME *1-STEP PREGNANCY
K973352 · Armkel, LLC · Oct 1997
QUICKSTICK ONE STEP HCG PREGNANCY TEST
K972682 · Phamatech · Aug 1997
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
K970082 · Abbott Laboratories · Jan 1997
QUICKSTICK ONE STEP PREGNANCY TEST(9010)
K962219 · Phamatech · Jul 1996
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
K962183 · Armkel, LLC · Jul 1996
TBD AT-HOME PREGNANCY TEST
K961712 · Armkel, LLC · May 1996