# K971312: Immulite Pyrilinks-D

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: May 27, 1997 after 48 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 K952320 (1995). 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)
- K952320: Pyrilinks-D Assay Kit, Metra Biosystems, Inc. (1995) Summary page 1.

## Indications for use
DPC's 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 in vitro diagnostic use as an indicator of bone resorption.

Source page: https://510kreport.com/device/K971312
Methodology: https://510kreport.com/methodology