Cleared Traditional

K130500 - CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT

K130500 is an FDA 510(k) clearance for CAPILLARYS IMMUNOTYPING, manufactured by Sebia. The device is a Class 1 Immunology device with product code CEF cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K130500 · Sebia · Immunology device
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Jul 2013
Decision
150d
Days
Class 1
Risk

K130500 is an FDA 510(k) clearance for the CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2.... Classified as Electrophoretic, Protein Fractionation (product code CEF), Class I - General Controls.

Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on July 26, 2013 after a review of 150 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1630 - 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 - K130500

510(k) Number K130500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2013
Decision Date July 26, 2013
Days to Decision 150 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
45d slower than avg
Panel avg: 105d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

CEF Device Classification - Class 1, General Controls

Product Code CEF Electrophoretic, Protein Fractionation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1630
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEF Electrophoretic, Protein Fractionation

All 27
Devices cleared under the same product code (CEF) and FDA review panel - the closest regulatory comparables to K130500.
SPIFE
K972274 · Helena Laboratories · Oct 1997
REP SPE VIS-60/40 KIT
K973316 · Helena Laboratories · Oct 1997
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS
K963018 · Bio-Rad · Jun 1997
REP 3 FLUR SPE-60 KIT
K964453 · Helena Laboratories · Dec 1996
HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT
K960029 · Morax · Jul 1996
HYDRAGEL PROTEIN(E) KIT
K951536 · Sebia · Jun 1995