Cleared Traditional

K063498 - HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)

K063498 is an FDA 510(k) clearance for HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356), manufactured by Sebia. The device is a Class 2 Immunology device with product code OBZ cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K063498 · Sebia · Immunology device
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Jun 2007
Decision
203d
Days
Class 2
Risk

K063498 is an FDA 510(k) clearance for the HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356). Classified as Alpha-1-antitrypsin Kit, Qualitative Phenotype (product code OBZ), Class II - Special Controls.

Submitted by Sebia (Great Neck, US). The FDA issued a Cleared decision on June 11, 2007 after a review of 203 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5130 - 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 Sebia devices

FDA 510(k) Submission Details - K063498

510(k) Number K063498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2006
Decision Date June 11, 2007
Days to Decision 203 days
Submission Type Traditional
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
98d slower than avg
Panel avg: 105d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OBZ Device Classification - Class 2, Special Controls

Product Code OBZ Alpha-1-antitrypsin Kit, Qualitative Phenotype
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5130
Definition The Alpha-1-antitrypsin Qualitative Phenotype Test Result Is Used As An Aid In The Diagnosis Of Alpha-1-antitrypsin Deficiency In Conjunction With Clinical And Other Laboratory Findings. For In Vitro Diagnostic Use Only.
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.