Cleared Traditional

K934516 - ADVANCE PREGNANCY TEST MODIFICATION

K934516 is the FDA 510(k) clearance for ADVANCE PREGNANCY TEST MODIFICATION by Ortho Pharmaceutical Corp.. It is a Class 2 Chemistry device (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)
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.

View all Ortho Pharmaceutical Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 88d · This submission: 160d
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 K934516.
LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
K945514 · Princeton BioMeditech Corp. · Feb 1995
PREGNANCY CHECK
K941355 · Sa Scientific, Inc. · Jul 1994
PREDICTOR HOME PREGNANCY TEST
K940637 · Organon Teknika Corp. · Jun 1994
PRECISE PREGNANCY
K930640 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
CONCEIVE ONE-STEP PREGNANCY TEST
K925096 · Quidel Corp. · Dec 1992
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
K921012 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992