# K982087: Roche CRP T Control N

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Aug 18, 1998 after 64 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- 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 K962373 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962373: N/T Rheumatology Control SL/1 and SL/2, Behring Diagnostics, Inc. (1996) Summary page 2.

## Most influential descendants
- K022725: Crpex CRP Controls Level L, M, H; Cat. NO.: 3011, 3012, 3013 (2002), 0 descendants of its own

## Indications for use
Roche CRP T Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentraion levels in quantitative C-reactive protein (CRP) assays. It is recommended for use with Roche reagents on COBAS® chemistry systems. Roche CRP T Control N is part of a C-reactive protein immunological test system, which is used to measure, by immunochemical techniques, the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Source page: https://510kreport.com/device/K982087
Methodology: https://510kreport.com/methodology