Cleared Traditional

HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT (K972591) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972591 · Morax · Immunology device
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Mar 1998
Decision
236d
Days
Class 2
Risk

K972591 is an FDA 510(k) clearance for the HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JON.... Classified as Immunochemical, Bence-jones Protein (product code JKM), Class II - Special Controls.

Submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on March 4, 1998 after a review of 236 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5150 - 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.

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Submission Details

510(k) Number K972591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1997
Decision Date March 04, 1998
Days to Decision 236 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 104d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JKM Immunochemical, Bence-jones Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5150
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.