# K030065: Wako Nefa Linearity Set

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Feb 11, 2003 after 35 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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
A quality control material (assayed and uuassayed) for clinical chemistry is a device intended for medical purposes for use in a test sytem to estimate test precision mcl to detect systematic analytivcal deviations that may arise fiom reagent or anafyticd instrument variation. A quality control material. (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed or unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Source page: https://510kreport.com/device/K030065
Methodology: https://510kreport.com/methodology