Cleared Traditional

K840833 - PREG BETA BLUS SLIDE

K840833 is the FDA 510(k) clearance for PREG BETA BLUS SLIDE by Intl. Diagnostic, Inc.. It is a Class 2 Chemistry device (product code JHJ) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K840833 · Intl. Diagnostic, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1984
Decision
96d
Days
Class 2
Risk

K840833 is an FDA 510(k) clearance for the PREG BETA BLUS SLIDE. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Intl. Diagnostic, Inc. (Walker, US). The FDA issued a Cleared decision on May 30, 1984 after a review of 96 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Intl. Diagnostic, Inc. devices

Submission Details

510(k) Number K840833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date May 30, 1984
Days to Decision 96 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 88d · This submission: 96d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 44
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K840833.
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
FERTITUBE PREGNANCY TEST #1120
K832867 · Stanbio Laboratory · Feb 1984
ORTHO B-HCG SLIDE TEST FOR PREGNANCY
K833137 · Ortho Diagnostic Systems, Inc. · Jan 1984