Cleared Traditional

K832867 - FERTITUBE PREGNANCY TEST #1120

K832867 is the FDA 510(k) clearance for FERTITUBE PREGNANCY TEST #1120 by Stanbio Laboratory. It is a Class 2 Chemistry device (product code JHJ) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K832867 · Stanbio Laboratory · Chemistry device
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Feb 1984
Decision
163d
Days
Class 2
Risk

K832867 is an FDA 510(k) clearance for the FERTITUBE PREGNANCY TEST #1120. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Stanbio Laboratory (Mchenry, US). The FDA issued a Cleared decision on February 3, 1984 after a review of 163 days - an extended review 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: 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 Stanbio Laboratory devices

Submission Details

510(k) Number K832867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1983
Decision Date February 03, 1984
Days to Decision 163 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 88d · This submission: 163d
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 28
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K832867.
PREGNANCY CARD TEST
K852066 · Em Diagnostic Systems, Inc. · Jun 1985
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914 · Abbott Laboratories · Feb 1985
STANBIO QUICK-TELL MONOCLONAL INDIRECT
K842544 · Stanbio Laboratory · Sep 1984
ORTHO B-HCG SLIDE TEST FOR PREGNANCY
K833137 · Ortho Diagnostic Systems, Inc. · Jan 1984
QUIDEL HCG ENZYME IMMUNOASSAY KIT
K833156 · Quidel Corp. · Nov 1983
B-SLIDE PREGNATE PREGNANCY TEST KIT
K832879 · Fisher Scientific Co., LLC · Oct 1983