# K101863: IT/IF Control

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Nov 7, 2011 after 493 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K130500: Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex Piercing Instrument (2013), 2 descendants of its own
- K161928: Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF Control (2016), 1 descendant of its own
- K192095: CAPI 3 Immunotyping, Capillarys 3 Tera (2019), 0 descendants of its own

## Indications for use
The IT I IF Control is designed for the qualitative quality control of the detection and characterization of human monoclonal immunoglobulins (IgG, IgA, 1gM, Kappa and Lambda) with the electrophoresis methods: - Immunotyping performed using capillary electrophoresis on SEBIA MINICAP instrument, - Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber. The IT I IF Control is designed for laboratory use. It should be used (with its barcode label for MINICAP procedure) like a human serum sample. The electrophoretic pattern obtained is specific for each batch of IT/IF control.

Source page: https://510kreport.com/device/K101863
Methodology: https://510kreport.com/methodology