Cleared Traditional

K844346 - FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES

K844346 is an FDA 510(k) clearance for FISHER DIAGNOSTICS PREGNACLONE SLIDE PR..., manufactured by Fisher Diagnostics. The device is a Class 2 Chemistry device with 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.

FDA 510(k) Submission Details - K844346

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 89d · This submission: 115d
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 92
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K844346.
DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST
K852286 · Sero-Immuno Diagnostics, Inc. · Jul 1985
PREGNANCY CARD TEST
K852066 · Em Diagnostic Systems, Inc. · Jun 1985
PRECO PREGNANCY RAPID CARD TEST, HEM #2028
K850604 · Preco, Inc. · Apr 1985
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914 · Abbott Laboratories · Feb 1985
FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT
K844347 · Fisher Diagnostics · Jan 1985
STANBIO QUICK-TELL MONOCLONAL INDIRECT
K842544 · Stanbio Laboratory · Sep 1984
K844346 · FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES
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