# K030482: Wiener Lab. Standatrol S-E 2 Niveles, Lovels 1&2: 3X5 ML Vials Cat.NR.1937553

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories
- Decided: Mar 19, 2003 after 34 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. The FDA summary names its predicate without a number.
- (no number) ROCHE Precinorm U: named in the summary without a submission number
- (no number) ROCHE Precipath U: named in the summary without a submission number

## Indications for use
The "Wiener lab. Standatrol S-E 2 niveles" is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. It may also be used for proficiency testing in interlaboratory surveys. This quality control material is used for monitoring accuracy and precision both for manual techniques and assays on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K030482
Methodology: https://510kreport.com/methodology