Cleared Traditional

K844346 - FISHER DIAGNOSTICS PREGNACLONE SLIDE PR...

K844346 is the FDA 510(k) clearance for FISHER DIAGNOSTICS PREGNACLONE SLIDE PR... by Fisher Diagnostics. It is a Class 2 Chemistry device (product code JHJ) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K844346 · Fisher Diagnostics · Chemistry device
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Mar 1985
Decision
115d
Days
Class 2
Risk

K844346 is an FDA 510(k) clearance for the FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Fisher Diagnostics (Orangeburg, US). The FDA issued a Cleared decision on March 4, 1985 after a review of 115 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.

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Submission Details

510(k) Number K844346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1984
Decision Date March 04, 1985
Days to Decision 115 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 88d · This submission: 115d
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 42
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K844346.
DELFIA (TM) HCG KIT
K862044 · Lkb Instruments, Inc. · Jul 1986
TERUMO SENSIBEAD EIG HCG KIT
K854670 · Terumo Medical Corp. · Feb 1986
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
DUOCLON COLOR-CEPT
K842314 · Organon, Inc. · Aug 1984