Cleared Traditional

K082388 - MINICAP IMMUNOTYPING, MODEL: 2300

K082388 is an FDA 510(k) clearance for MINICAP IMMUNOTYPING, manufactured by Sebia. The device is a Class 2 Immunology device with product code CFF cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K082388 · Sebia · Immunology device
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Apr 2009
Decision
238d
Days
Class 2
Risk

K082388 is an FDA 510(k) clearance for the MINICAP IMMUNOTYPING, MODEL: 2300. Classified as Immunoelectrophoretic, Immunoglobulins, (g, A, M) (product code CFF), Class II - Special Controls.

Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on April 14, 2009 after a review of 238 days - an extended review cycle.

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 Sebia devices

FDA 510(k) Submission Details - K082388

510(k) Number K082388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2008
Decision Date April 14, 2009
Days to Decision 238 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
133d slower than avg
Panel avg: 105d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 26
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