# K041073: Document Salicylate Cal Ver

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: May 21, 2004 after 25 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
Longest line of descent: 2 generations back to K950469 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992034: Document Thyroid Cal*Ver, Casco-Nerl Diagnostics Corporation (Maine) (1999) Summary page 1.

## Indications for use
The DOCUMENT® Salicylate CAL-VER® solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification, verification of Analytical Measurement Range (AMR) and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance. There exists a linear relationship among each of the solutions.

Source page: https://510kreport.com/device/K041073
Methodology: https://510kreport.com/methodology