510(k) · Cleared
ClearedImmulite Pyrilinks-D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · JMM Column Chromatography & Color Development, Hydroxyproline
Cleared on May 27, 1997 as substantially equivalent to K952320 (Metra Biosystems, Inc., 1995) after a 48-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- May 27, 1997
- Review
- 48 days
- Class
- Class I
- Product code
- JMM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952320 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952320 Pyrilinks-D Assay KitMetra Biosystems, Inc. · 1995
- This deviceK971312 Immulite Pyrilinks-DDiagnostic Products Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952320 | Pyrilinks-D Assay Kit | Metra Biosystems, Inc. | 1995 | — |
| 0 (this device) | K971312 | Immulite Pyrilinks-D | Diagnostic Products Corp. | 1997 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JMM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952320 | Pyrilinks-D Assay KitSummary page 1…tests Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597 DPC's Registration Number 1s 2017183 Metra Biosvstemns® Pynilinks®-D (K952320) IMMULITE? Pyrilinks®-D is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer The IMMULITE® Pyrilinks®… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All JMM devicesJMM Column Chromatography & Color Development, Hydroxyproline: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JMM
FDA has decided no JMM device since 2007.
Median 510(k) review, days · JMM
Too few JMM 510(k)s in any year since 2007 to give a median.
Recalls per year · JMM
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JMM
1in 2025
MAUDE reports naming product code JMM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971312: Immulite Pyrilinks-D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971312
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026