Cleared Traditional

K972591 - HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT

K972591 is an FDA 510(k) clearance for HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRA..., manufactured by Morax. The device is a Class 2 Immunology device with product code JKM cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K972591 · Morax · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Morax devices

FDA 510(k) Submission Details - K972591

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 105d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKM Device Classification - Class 2, Special Controls

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.