510(k) · Cleared
Recalled · Class II · 2019C-Reactive Protein Kit for use on SPAPLUS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group · DCN System, Test, C-Reactive Protein
Cleared on Apr 5, 2017 as substantially equivalent to K083444 (Roche Diagnostics Corp., 2009) after a 260-day review. Its family tree reaches back 5 generations to 1989. It has been recalled once.
- Decided
- Apr 5, 2017
- Review
- 260 days
- Class
- Class II
- Product code
- DCN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K895880 (1989). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
- 4 generations backK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
- 3 generations backK003400 CRP HS Test SystemRoche Diagnostics Corp. · 2001
- 2 generations backK032336 Tina-Quant CRP (Latex)Roche Diagnostics Corp. · 2003
- 1 generation backK083444 C-Reactive Protein (Latex)Roche Diagnostics Corp. · 2009 · Recalled
- This deviceK161982 C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | 1989 | — |
| −4 | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… | Roche Diagnostic Systems, Inc. | 1998 | — |
| −3 | K003400 | CRP HS Test System | Roche Diagnostics Corp. | 2001 | — |
| −2 | K032336 | Tina-Quant CRP (Latex) | Roche Diagnostics Corp. | 2003 | — |
| −1 | K083444 | C-Reactive Protein (Latex) | Roche Diagnostics Corp. | 2009 | 1 |
| 0 (this device) | K161982 | C-Reactive Protein Kit for use on SPAPLUS | The Binding Site Group | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
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 DCN? 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 DCN device
- #1 K232624 CardioPhase® hsCRPscore 6.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K083444 | C-Reactive Protein (Latex)Summary page 5…servatives. J. Substantial equivalence information: 1. Predicate device name(s) and 510(k) number(s): Roche Diagnostics Tina-Quant C-Reactive Protein Gen. 3 (K083444) C-Reactive Protein Kit for use on SPAPLUS… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 25, 2019 | Class II | Z-1619-2020 | Nonconforming Material/Component | A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K083444.
How does its category compare?
All DCN devicesDCN System, Test, C-Reactive Protein: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DCN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DCN
234in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DCN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCN
7in 2025
MAUDE reports naming product code DCN, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 3 | 111 | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 234 | 0 | 2 |
| 2019 | 0 | — | 1 | 8 |
| 2020 | 1 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The C-Reactive Protein Kit for use on SPAPLUS is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This product is suitable for use on the SPAPLUS analyser.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161982: C-Reactive Protein Kit for use on SPAPLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161982
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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