# K121279: Elecsys LH Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: May 10, 2012 after 10 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K121104: Elecsys N-MID Osteocalcin CalCheck 5. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Elecsys LH CaiCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys LH reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K121279
Methodology: https://510kreport.com/methodology