Cleared Traditional

K963341 - MIDSTREAM ONESTEP PREGNANCY HOME TEST

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

K963341 · Syntron Bioresearch, Inc. · Chemistry device
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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

FDA 510(k) Submission Details - K963341

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
Combination Product No
PCCP Authorized No
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.

LCX Device Classification - Class 2, Special Controls

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 166
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K963341.
ADVANCED QUALITY PREGNANCY TEST
K970008 · Bionike, Inc. · Feb 1997
PERFECTA PREGNANCY TEST
K965184 · Wyntek Diagnostics, Inc. · Feb 1997
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
K970082 · Abbott Laboratories · Jan 1997
FACT PLUS PREGNANCY TEST
K964108 · Direct Access Diagnostics · Nov 1996
NATURALE HCG PREGNANCY TES
K964002 · Mizuho USA, Inc. · Nov 1996
EVIDENCE PREGNANCY TEST
K962721 · Saliva Diagnostic Systems · Oct 1996