# K984419: Elecsys Ige Calcheck

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Feb 2, 1999 after 54 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
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 IgE calibration verification solutions comprise three levels - low, mid, and high - each with a defined IgE concentration. The low solution concentration is near the lower detection limit of the assay. The middle 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 IgE is intended for use in periodic verification of the calibration of the Elecsys IgE assay.

Source page: https://510kreport.com/device/K984419
Methodology: https://510kreport.com/methodology