510(k) · Cleared
ClearedCRP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · DCN System, Test, C-Reactive Protein
Cleared on Jun 1, 1999 as substantially equivalent to K930621 (Boehringer Mannheim Corp., 1993) after a 42-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jun 1, 1999
- Review
- 42 days
- Class
- Class II
- Product code
- DCN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930621 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK930621 Tina-Quant CRPBoehringer Mannheim Corp. · 1993
- This deviceK991372 CRPAbbott Laboratories · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930621 | Tina-Quant CRP | Boehringer Mannheim Corp. | 1993 | — |
| 0 (this device) | K991372 | CRP | Abbott Laboratories | 1999 | — |
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 |
|---|---|---|---|
| * | K930621 | Tina-Quant CRPSummary page 1…reactive protein in the sample. Substantial Equivalence: The C-Reactive Protein assay is substantially equivalent to the Boehringer Mannheim® C-Reactive Protein assay (K930621) on the Hitachi® 717 Analyzer. C-Reactive Protein 510(k) Section Il April 19, 1999 Page | Cop 00000411 These as… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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.
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.
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 assay is used for the quantitation of C-reactive protein in human serum and plasma. 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/K991372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991372: CRP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991372
Report an extraction error
Are you the manufacturer?
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