# K972580: Deoxypyridinoline Assay for the Bayer Immuno 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Sep 22, 1997 after 74 days
- Product code: JMM (Column Chromatography & Color Development, Hydroxyproline)
- Device class: 1
- Regulation: 21 CFR 862.1400
- 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) Pyrilinks®-D: named in the summary without a submission number

## Indications for use
This in vitro diagnostic method is intended to quantitatively measure deoxypyridinoline (DPD) in human urine on the Bayer Immuno 1™ system. Measurements obtained by this device are used as an indicator of bone resorption. Results obtained using the Bayer Immuno 1 system Deoxypyridinoline method are generally expressed as a ratio to urine creatinine (nM DPD/mM creatinine), and should be interpreted in conjunction with all other available clinical and diagnostic results. The urine creatinine result (mmol/L) must be entered from an off-system standard laboratory analysis. This diagnostic method is not intended for use on any other system.

Source page: https://510kreport.com/device/K972580
Methodology: https://510kreport.com/methodology