# K980833: Immulite Pyrilinks-D Model Numbers LKPD1, LKPD5

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: May 1, 1998 after 58 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
Longest line of descent: 1 generation back to K974260 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974260: Pyrilinks-D Assay Kit, Metra Biosystems, Inc. (1998) Summary page 1.

## Indications for use
IMMULITE Pyrilinks-D is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE Automated Analyzer and is designed for the quantitative measurement of deoxypyridinoline (DPD) in urine. It is intended strictly for ir vitro diagnostic use in monitoring type 1 collagen resorption changes, especially in bone in post menopausal wormen diagnosed with osteoparosis and receiving antiresorptive therapy (amino-bisphosphonate).

Source page: https://510kreport.com/device/K980833
Methodology: https://510kreport.com/methodology