# K131479: V8 SP Normal Control, Abnormal Control

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Oct 7, 2013 after 138 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
VS SP Normal Control is to be used as a qualitative and/or quantitative control for serum protein by Helena VS Capillary Electrophoresis (CE) System. VS SP Abnormal Control is to be used as a qualitative and/or quantitative control for serum protein by Helena V8 Capillary Electrophoresis (CE) System.

Source page: https://510kreport.com/device/K131479
Methodology: https://510kreport.com/methodology