# K983674: Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX Controls

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jan 29, 1999 after 101 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 K980518 (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)
- K980518: Osteomark, Ostex Intl., Inc. (1998) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K983674
Methodology: https://510kreport.com/methodology