Cleared Traditional

K874638 - V-TREND BETA-HCG TEST

K874638 is the FDA 510(k) clearance for V-TREND BETA-HCG TEST by Texas Immunology, Inc.. It is a Class 2 Immunology device (product code JHJ) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K874638 · Texas Immunology, Inc. · Immunology device
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Jan 1988
Decision
70d
Days
Class 2
Risk

K874638 is an FDA 510(k) clearance for the V-TREND BETA-HCG TEST. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Texas Immunology, Inc. (Tyler, US). The FDA issued a Cleared decision on January 21, 1988 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1155 - the FDA immunology device 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.

View all Texas Immunology, Inc. devices

Submission Details

510(k) Number K874638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1987
Decision Date January 21, 1988
Days to Decision 70 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 104d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHJ Agglutination Method, Human Chorionic Gonadotropin
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 Immunology devices follow this clearance model.

Regulatory Peers - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 42
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K874638.
CLEARVIEW HCG
K910946 · Unipath , Ltd. · Apr 1991
PREGNOSPIA II
K881435 · Organon Teknika Corp. · May 1988
HCG-NOSTICK
K880328 · Organon Teknika Corp. · Mar 1988
PREGNASLIDE
K863198 · Armkel, LLC · Sep 1986
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
K861703 · Leeco Diagnostics, Inc. · Jul 1986
DELFIA (TM) HCG KIT
K862044 · Lkb Instruments, Inc. · Jul 1986