Cleared Special

K143483 - MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING

K143483 is an FDA 510(k) clearance for MINICAP Immunotyping using the MINICAP ..., manufactured by Sebia. The device is a Class 2 Immunology device with product code CFF cleared through the Special 510(k) pathway after a 31-day FDA review.

K143483 · Sebia · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
31d
Days
Class 2
Risk

K143483 is an FDA 510(k) clearance for the MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING. 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 January 8, 2015 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K143483

510(k) Number K143483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2014
Decision Date January 08, 2015
Days to Decision 31 days
Submission Type Special
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
74d faster than avg
Panel avg: 105d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (CFF) and FDA review panel - the closest regulatory comparables to K143483.
HYDRASHIFT 2/4 daratumumab
K190851 · Sebia · May 2019
HYDRASHIFT 2/4 daratumumab, daratumumab Control
K172195 · Sebia · Jan 2018
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
K161928 · Sebia · Dec 2016
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
K120169 · Grifols USA, LLC · Aug 2012
THE HELENA V8 IMMUNODISPLACEMENT KIT
K111369 · Helena Laboratories Uk, Ltd. · Jun 2012
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
K103757 · Grifols · Oct 2011
K143483 · MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
Download PDF FDA Summary Sebia