Cleared Traditional

K960669 - HYDRAGEL IF

K960669 is the FDA 510(k) clearance for HYDRAGEL IF by Morax. It is a Class 2 Immunology device (product code CFF) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K960669 · Morax · Immunology device
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Jul 1996
Decision
143d
Days
Class 2
Risk

K960669 is an FDA 510(k) clearance for the HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS. Classified as Immunoelectrophoretic, Immunoglobulins, (g, A, M) (product code CFF), Class II - Special Controls.

Submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on July 12, 1996 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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

Submission Details

510(k) Number K960669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1996
Decision Date July 12, 1996
Days to Decision 143 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
39d slower than avg
Panel avg: 104d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)

All 17
Devices cleared under the same product code (CFF) and FDA review panel - the closest regulatory comparables to K960669.
K-ASSAY IGA
K993213 · Kamiya Biomedical Co. · Nov 1999
POLYSLIT IFE KIT
K990998 · Helena Laboratories · Jun 1999
SPIFE IFE-6
K973040 · Helena Laboratories · Jan 1998
IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC
K924767 · The Binding Site, Ltd. · Feb 1993
IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC
K924769 · The Binding Site, Ltd. · Feb 1993
REP IMMUNOFIX
K923658 · Helena Laboratories · Nov 1992