# K984530: DRX NTX or, Osteomark NTX Direct Response

- Pathway: 510(k) (Traditional)
- Applicant: Metrika, Inc.
- Decided: Aug 10, 1999 after 232 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- 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 K854766 (1986). 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)
- K854766: Creatinine Pap, Boehringer Mannheim Corp. (1986) Summary page 3.
- (no number) Osteomark® NTx EIA: named in the summary without a submission number

## Indications for use
Osteomark NTx Point of Care (POC) is a urinary assay for the quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The test is used to monitor bone resorption changes following initiation of antiresorptive therapy (e.g., hormone replacement therapy).

Source page: https://510kreport.com/device/K984530
Methodology: https://510kreport.com/methodology