# K981364: Pyrilinks-D Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Metra Biosystems, Inc.
- Decided: Aug 13, 1998 after 120 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Measurement of Dpd is intended for use as an aid in monitoring bone resorption changes in postmenopausal women receiving hormonal or bisphosphonate antiresorptive therapies and in individuals diagnosed with osteoporosis.

Source page: https://510kreport.com/device/K981364
Methodology: https://510kreport.com/methodology