510(k) · Cleared

Cleared

Roche CRP T Control N

K982087510(k) TraditionalCleared Aug 18, 199864-day reviewClass II21 CFR 866.5270

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Diagnostic Systems, Inc. · DCK C-Reactive Protein, Antigen, Antiserum, And Control

Cleared on Aug 18, 1998 as substantially equivalent to K962373 (Behring Diagnostics, Inc., 1996) after a 64-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Aug 18, 1998
Review: 64 days
Class: Class II
Product code: DCK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962373 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK962373 N/T Rheumatology Control SL/1 and SL/2Behring Diagnostics, Inc. · 1996
This deviceK982087 Roche CRP T Control NRoche Diagnostic Systems, Inc. · 1998
Descendant · cites it directly · 0 of its ownK022725 Crpex CRP Controls Level L, M, H; Cat. NO.: 3011, 3012, 3013Good Biotech Corp. · 2002

Most influential descendants

Showing 1 of 1 · See all

K022725Crpex CRP Controls Level L, M, H; Cat. NO.: 3011, 3012, 3013Good Biotech Corp. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962373	N/T Rheumatology Control SL/1 and SL/2	Behring Diagnostics, Inc.	1996	—
0 (this device)	K982087	Roche CRP T Control N	Roche Diagnostic Systems, Inc.	1998	—
+1	K022725	Crpex CRP Controls Level L, M, H; Cat. NO.: 3011, 3012, 3013	Good Biotech Corp.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K982087, 1996–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DCK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DCK device

#1 K242170 K-ASSAY CRP (Ver.2)score 9.2 · 1 generation · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K962373	N/T Rheumatology Control SL/1 and SL/2 Summary page 2 …iagnostic Systems, Inc. claims equivalence. Table 2 Product Name Predicate Product Date Predicate Name Predicate 510(k) Cleared Number Roche Behring Diagnostics 7/11/96 K962373 CRP T Control N N/T Rheumatology Control SL 1 /2 Description of the Device/Statement of Intended Use: Roche CRP T Control N is…	Behring Diagnostics, Inc.	1996	—

Also cleared against K962373: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022725	Crpex CRP Controls Level L, M, H; Cat. NO.: 3011, 3012, 3013	Good Biotech Corp.	2002	0

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.
Of its descendants, K022725 (Good Biotech Corp., 2002) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K962373.

How does its category compare?

All DCK devices

DCK C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DCK

1in 2025

2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DCK

Too few DCK 510(k)s in any year since 2007 to give a median.

Recalls per year · DCK

1in 2024

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DCK

1in 2021

2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code DCK, 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	—	1	1
2009	0	—	1	0
2010	0	—	0	0
2011	1	—	0	1
2012	1	—	0	1
2013	0	—	1	0
2014	0	—	0	1
2015	2	—	0	0
2016	1	—	1	0
2017	1	—	0	0
2018	0	—	0	0
2019	2	—	0	0
2020	1	—	0	0
2021	0	—	0	1
2022	1	—	0	0
2023	0	—	0	0
2024	0	—	1	0
2025	1	—	0	0
2026	0	—	0	—

What is it indicated for?

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.

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/K982087 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982087: Roche CRP T Control N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982087

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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