Cleared Traditional

K841853 - PREG-BETA ONE HOUR TUBE TEST

K841853 is an FDA 510(k) clearance for PREG-BETA ONE HOUR TUBE TEST, manufactured by Intl. Diagnostic, Inc.. The device is a Class 2 Chemistry device with product code JHJ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K841853 · Intl. Diagnostic, Inc. · Chemistry device
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Jun 1984
Decision
50d
Days
Class 2
Risk

K841853 is an FDA 510(k) clearance for the PREG-BETA ONE HOUR TUBE TEST. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Intl. Diagnostic, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 50 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.

View all Intl. Diagnostic, Inc. devices

FDA 510(k) Submission Details - K841853

510(k) Number K841853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1984
Decision Date June 22, 1984
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 55
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K841853.
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914 · Abbott Laboratories · Feb 1985
STANBIO QUICK-TELL MONOCLONAL INDIRECT
K842544 · Stanbio Laboratory · Sep 1984
DUOCLON COLOR-CEPT
K842314 · Organon, Inc. · Aug 1984
B-NEOCEPT 30
K840650 · Organon, Inc. · Apr 1984
BHCG-CHECK
K834346 · Diagnostic Technology, Inc. · Feb 1984
FERTITUBE PREGNANCY TEST #1120
K832867 · Stanbio Laboratory · Feb 1984