Cleared Special

K033277 - HYDRAGEL CSF ISOFOCUSING KITS

K033277 is an FDA 510(k) clearance for HYDRAGEL CSF ISOFOCUSING KITS, manufactured by Morax. The device is a Class 2 Immunology device with product code CFF cleared through the Special 510(k) pathway after a 25-day FDA review.

K033277 · Morax · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
25d
Days
Class 2
Risk

K033277 is an FDA 510(k) clearance for the HYDRAGEL CSF ISOFOCUSING KITS. Classified as Immunoelectrophoretic, Immunoglobulins, (g, A, M) (product code CFF), Class II - Special Controls.

Submitted by Morax (Norcross, US). The FDA issued a Cleared decision on November 4, 2003 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033277

510(k) Number K033277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2003
Decision Date November 04, 2003
Days to Decision 25 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 105d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

CFF Device Classification - Class 2, Special Controls

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 28
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K033277 · HYDRAGEL CSF ISOFOCUSING KITS
Download PDF FDA Summary Morax