# K991917: Osteomark NTX Point of Care (Poc) Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Metrika, Inc.
- Decided: Jul 12, 1999 after 35 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K981933 (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)
- K981933: Urichemtrak Liquid Assayed Control Levels 1 and 2, Medical Analysis Systems, Inc. (1998) Summary page 2.

## Indications for use
The Osteomark NTx Point of Care (POC) Controls are assayed for the verification of device performance when using the Osteomark NTx POC for the quantitative measure of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The controls are used as consistent test samples of known nM BCE/mM creatinine concentration that may be measured over time as a means of evaluating analytical precision, as well as device performance.

Source page: https://510kreport.com/device/K991917
Methodology: https://510kreport.com/methodology