510(k) · Cleared
ClearedVitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JMM Column Chromatography & Color Development, Hydroxyproline
Cleared on Jan 29, 1999 as substantially equivalent to K980518 (Ostex Intl., Inc., 1998) after a 101-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jan 29, 1999
- Review
- 101 days
- Class
- Class I
- Product code
- JMM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980518 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK980518 OsteomarkOstex Intl., Inc. · 1998
- This deviceK983674 Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack…Ortho-Clinical Diagnostics, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980518 | Osteomark | Ostex Intl., Inc. | 1998 | — |
| 0 (this device) | K983674 | Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX… | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
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 |
|---|---|---|---|
| * | K980518 | OsteomarkSummary page 1…tides of type I collagen (NTx) in human urine. 3. Predicate Device The VITROS Immunodiagnostic Products NTx assay is substantially equivalent to the Osteomark NTx Test (K980518) 4. Device Description The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantita… | 1998 |
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?
Vitros NTx Reagent Pack — For in-vitro quantitative measurement of cross linked N-telopeptides of type I collagen (NTx) in human urine as an indicator of human bone resorption. A single NTx value cannot provide the rate of bone resorption as reported results do not contain a measure of time. Use of this test has not been established in primary hyperparathyroidism or hyperthyroidism. Vitros NTx Calibrators — For in-vitro use in the calibration of the…
Read the full statement (115 words)
Vitros NTx Reagent Pack — For in-vitro quantitative measurement of cross linked N-telopeptides of type I collagen (NTx) in human urine as an indicator of human bone resorption. A single NTx value cannot provide the rate of bone resorption as reported results do not contain a measure of time.
Use of this test has not been established in primary hyperparathyroidism or hyperthyroidism.
Vitros NTx Calibrators — For in-vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of NTx in human urine.
Vitros NTx Controls — For in-vitro use in the monitoring of the performance of the VITROS Immunodiagnostic System when used for the quantitative measurement of NTx in human urine.
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/K983674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983674: Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983674
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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