Cleared Traditional

K934830 - HCG PREGNANCY ONE STEP TEST STRIP

K934830 is an FDA 510(k) clearance for HCG PREGNANCY ONE STEP TEST STRIP, manufactured by Tcpi, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K934830 · Tcpi, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
55d
Days
Class 2
Risk

K934830 is an FDA 510(k) clearance for the HCG PREGNANCY ONE STEP TEST STRIP. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Tcpi, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on December 2, 1993 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K934830

510(k) Number K934830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1993
Decision Date December 02, 1993
Days to Decision 55 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
34d faster than avg
Panel avg: 89d · This submission: 55d
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 K934830.
ANI BIOCARD(TM) HCG TEST
K933794 · Canadian Bioclinical, Ltd. · May 1994
EVATEST STRIP
K936013 · Boehringer Mannheim Italia Spa · Feb 1994
ADVANCE PREGNANCY TEST MODIFICATION
K934516 · Ortho Pharmaceutical Corp. · Feb 1994
HCG MIDSTREAM PREGNANCY TEST
K931997 · Mizuho USA, Inc. · Sep 1993
BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST
K930488 · Syntron Bioresearch, Inc. · Apr 1993
PRECISE PREGNANCY
K930640 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
K934830 · HCG PREGNANCY ONE STEP TEST STRIP
Download PDF FDA Summary Tcpi, Inc.