# K993642: Elecsys Parathyroid Hormone Calcheck

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 30, 1999 after 33 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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

## Most influential descendants
- K103162: Elecsys PTH Calcheck 5 (2010), 0 descendants of its own

## Indications for use
Elecsys® Parathyroid Hormone CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined parathyroid hormone 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® Parathyroid Hormone CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Parathyroid Hormone test.

Source page: https://510kreport.com/device/K993642
Methodology: https://510kreport.com/methodology