Cleared Traditional

K013702 - VICTORCH HCG TEST STRIP

K013702 is an FDA 510(k) clearance for VICTORCH HCG TEST STRIP, manufactured by Victorch Meditek, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K013702 · Victorch Meditek, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
49d
Days
Class 2
Risk

K013702 is an FDA 510(k) clearance for the VICTORCH HCG TEST STRIP. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Victorch Meditek, Inc. (San Diego, US). The FDA issued a Cleared decision on December 27, 2001 after a review of 49 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 - K013702

510(k) Number K013702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2001
Decision Date December 27, 2001
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 89d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
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 Consultant

California Department of Health Services
RAYMOND WILSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 374
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K013702.
QUICKVUE ONE-STEP HCG-COMBO
K020801 · Quidel Corp. · May 2002
SAS VALUE HCG
K020438 · Sa Scientific, Inc. · Mar 2002
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128 · Diagnostic Systems Laboratories, Inc. · Mar 2002
POLY STAT HCG TEST
K012559 · Bion Diagnostic Sciences · Oct 2001
UNIMARK HCG COMBO PREGNANCY TEST
K013194 · Biotech Atlantic, Inc. · Oct 2001
WH ACCU TEST PREGNANCY TEST
K012284 · W.H.P.M., Inc. · Aug 2001
K013702 · VICTORCH HCG TEST STRIP
Download PDF FDA Summary Victorch Meditek, Inc.