# K974260: Pyrilinks-D Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Metra Biosystems, Inc.
- Decided: Jan 26, 1998 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K980833: Immulite Pyrilinks-D Model Numbers LKPD1, LKPD5 (1998), 0 descendants of its own

## Indications for use
Pyrilinks-D is a urinary assay that provides a quantitative measure of the excretion of deoxypyridinoline (Dpd) crosslinks as an indicator of bone resorption. Elevated levels of urinary Dpd indicate elevated bone resorption in individuals. Mecasurement of Dpd is intended for use in monitoring bone resorption changes in postmenopausal women receiving antiresorptive therapies and in individuals diagnosed with-osteoporosis.

Source page: https://510kreport.com/device/K974260
Methodology: https://510kreport.com/methodology