Cleared Traditional

K103757 - IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT

K103757 is an FDA 510(k) clearance for IMMUNOFIXATION ELECTROPHORESIS TEST USI..., manufactured by Grifols. The device is a Class 2 Immunology device with product code CFF cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K103757 · Grifols · Immunology device
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Oct 2011
Decision
294d
Days
Class 2
Risk

K103757 is an FDA 510(k) clearance for the IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT. Classified as Immunoelectrophoretic, Immunoglobulins, (g, A, M) (product code CFF), Class II - Special Controls.

Submitted by Grifols (East Stroudsburg, US). The FDA issued a Cleared decision on October 13, 2011 after a review of 294 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.

FDA 510(k) Submission Details - K103757

510(k) Number K103757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2010
Decision Date October 13, 2011
Days to Decision 294 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
189d slower than avg
Panel avg: 105d · This submission: 294d
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 28
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K103757 · IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
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