# K981278: Elecsys Calcheck CA 125II

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics GmbH
- Decided: Apr 23, 1998 after 15 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 FDA summary names its predicate without a number.
- (no number) Elecsys® CalCheck™ TSH: named in the summary without a submission number

## Indications for use
Elecsys® CalCheck™ CA 125II calibration verification solutions comprise three levels - low, mid, and high - each with a defined CA 125II concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range. The Elecsys® CalCheck™ CA 125II is intended for use in periodic verification of the calibration of the Elecsys® CA 125II assay.

Source page: https://510kreport.com/device/K981278
Methodology: https://510kreport.com/methodology