Cleared Traditional

K011113 - HYDRAGEL ISO-PAL K20 (PN 3022)

Also marketed or referenced as:
HYDRAGEL 7 ISO-PAL (PN 4112) HYDRAGEL 15 ISO-PAL (PN 4132)

K011113 is an FDA 510(k) clearance for HYDRAGEL ISO-PAL K20 (PN 3022), manufactured by Sebia. The device is a Class 2 Chemistry device with product code CIN cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K011113 · Sebia · Chemistry device
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Jun 2001
Decision
63d
Days
Class 2
Risk

K011113 is an FDA 510(k) clearance for the HYDRAGEL ISO-PAL K20 (PN 3022). Classified as Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN), Class II - Special Controls.

Submitted by Sebia (Chelsea, US). The FDA issued a Cleared decision on June 13, 2001 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sebia devices

FDA 510(k) Submission Details - K011113

510(k) Number K011113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2001
Decision Date June 13, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIN Device Classification - Class 2, Special Controls

Product Code CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 Chemistry devices follow this clearance model.

Regulatory Peers - CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

All 22
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