Cleared Traditional

K854222 - DIESSE RF TEST KIT

K854222 is the FDA 510(k) clearance for DIESSE RF TEST KIT by Marvic Interpharma, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K854222 · Marvic Interpharma, Inc. · Immunology device
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Feb 1986
Decision
111d
Days
Class 2
Risk

K854222 is an FDA 510(k) clearance for the DIESSE RF TEST KIT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Marvic Interpharma, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on February 6, 1986 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Marvic Interpharma, Inc. devices

Submission Details

510(k) Number K854222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1985
Decision Date February 06, 1986
Days to Decision 111 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 104d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 Immunology devices follow this clearance model.

Regulatory Peers - DHR System, Test, Rheumatoid Factor

All 88
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K854222.
REUMA TEST
K873782 · Sclavo, Inc. · Nov 1987
RF MICROASSAY
K871041 · Diamedix Corp. · Mar 1987
SERATEST RF (HEMAGGLUTINATION) KIT
K855221 · Hemagen Diagnostics, Inc. · Apr 1986
RA 80 EIKEN
K854820 · Syn-Kit, Inc. · Jan 1986
LASER RF CONTROL SERUM-QUALITY CONTROL SERUM
K851537 · Behring Diagnostics, Inc. · Jun 1985
LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS
K850296 · Behring Diagnostics, Inc. · Apr 1985