Cleared Traditional

K874638 - V-TREND BETA-HCG TEST

K874638 is an FDA 510(k) clearance for V-TREND BETA-HCG TEST, manufactured by Texas Immunology, Inc.. The device is a Class 2 Immunology device with 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.

FDA 510(k) Submission Details - K874638

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 105d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHJ Device Classification - Class 2, Special Controls

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 95
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K874638.
PREGNANCY BETA-HCG CARD & LIQUID TEST
K880478 · Ampcor, Inc. · Apr 1988
HCG-NOSTICK
K880328 · Organon Teknika Corp. · Mar 1988
V-TREND BETA-HCG DRY-SPOT TEST
K875262 · Texas Immunology, Inc. · Feb 1988
ACU-PREG-AL SLIDE TEST
K871294 · Papibris Scientific, Inc. · May 1987
IMMUNO-CEPT D (BETA-MONOCLONAL)
K863741 · Immunostics Co., Inc. · Nov 1986
MONO ACU-SLIDE TEST
K861211 · Cal-Tech Diagnostics, Inc. · Nov 1986
K874638 · V-TREND BETA-HCG TEST
Download PDF Texas Immunology, Inc.