# K020883: Elecsys Probnp Calcheck

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 29, 2002 after 256 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
Longest line of descent: 1 generation back to K001015 (2000). 1 ancestor in all.
47 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001015: Elecsys Thyroglobulin Calcheck, Roche Diagnostics Corp. (2000)

## Most influential descendants
- K031698: Elecys SHBG Calcheck (2003), 44 descendants of its own
- K040157: Elecsys C-Peptide Calcheck (2004), 42 descendants of its own
- K100810: Elecsys  C-Peptide Calcheck 5 (2010), 32 descendants of its own
- K051185: Elecsys CA 19-9 Calcheck (2005), 12 descendants of its own
- K101365: Elecsys CA 19-9 Calcheck 5 (2010), 11 descendants of its own

## Indications for use
ElecsysO proBNP CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined proBNP concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at a clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range. The ElecsysO proBNP CalCheck is intended for use in the verification of the calibration established by the ElecsysO proBNP reagent on ElecsysB 1010/201O/MODULAR ANALYTICS E l 70 immunoassay analyzers.

Source page: https://510kreport.com/device/K020883
Methodology: https://510kreport.com/methodology