Cleared Traditional

K934516 - ADVANCE PREGNANCY TEST MODIFICATION

K934516 is an FDA 510(k) clearance for ADVANCE PREGNANCY TEST MODIFICATION, manufactured by Ortho Pharmaceutical Corp.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K934516 · Ortho Pharmaceutical Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
160d
Days
Class 2
Risk

K934516 is an FDA 510(k) clearance for the ADVANCE PREGNANCY TEST MODIFICATION. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Ortho Pharmaceutical Corp. (Raritan, US). The FDA issued a Cleared decision on February 24, 1994 after a review of 160 days - an extended review 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: 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.

FDA 510(k) Submission Details - K934516

510(k) Number K934516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1993
Decision Date February 24, 1994
Days to Decision 160 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
71d slower than avg
Panel avg: 89d · This submission: 160d
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 225
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K934516.
PREDICTOR HOME PREGNANCY TEST
K940637 · Organon Teknika Corp. · Jun 1994
ANI BIOCARD(TM) HCG TEST
K933794 · Canadian Bioclinical, Ltd. · May 1994
EVATEST STRIP
K936013 · Boehringer Mannheim Italia Spa · Feb 1994
HCG PREGNANCY ONE STEP TEST STRIP
K934830 · Tcpi, Inc. · Dec 1993
HCG MIDSTREAM PREGNANCY TEST
K931997 · Mizuho USA, Inc. · Sep 1993
BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST
K930488 · Syntron Bioresearch, Inc. · Apr 1993
K934516 · ADVANCE PREGNANCY TEST MODIFICATION
Download PDF FDA Summary Ortho Pharmaceutical …