Cleared Traditional

K161928 - CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL

K161928 is an FDA 510(k) clearance for CAPI 3 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 160-day FDA review.

K161928 · Sebia · Immunology device
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Dec 2016
Decision
160d
Days
Class 2
Risk

K161928 is an FDA 510(k) clearance for the CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL. 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 December 21, 2016 after a review of 160 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 - K161928

510(k) Number K161928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2016
Decision Date December 21, 2016
Days to Decision 160 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
55d slower than avg
Panel avg: 105d · This submission: 160d
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
Devices cleared under the same product code (CFF) and FDA review panel - the closest regulatory comparables to K161928.
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