510(k) · Cleared
ClearedCardioPhase® hsCRP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics Products GmbH · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Dec 16, 2022 as substantially equivalent to K033908 (Dade Behring, Inc., 2004) after a 490-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Dec 16, 2022
- Review
- 490 days
- Class
- Class II
- Product code
- NQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991385 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK991385 Dade Behring N High Sensitivity CRP AssayDade Behring, Inc. · 1999
- 1 generation backK033908 N High Sensitivity CRPDade Behring, Inc. · 2004
- This deviceK212559 CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH · 2022
- Descendant · cites it directly · 0 of its ownK233242 Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233242Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991385 | Dade Behring N High Sensitivity CRP Assay | Dade Behring, Inc. | 1999 | — |
| −1 | K033908 | N High Sensitivity CRP | Dade Behring, Inc. | 2004 | — |
| 0 (this device) | K212559 | CardioPhase® hsCRP | Siemens Healthcare Diagnostics Products GmbH | 2022 | — |
| +1 | K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 NQD? 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 NQD device
- #1 K260026 Tina-quant Cardiac high sensitivity CRP IIIscore 12.3 · 5 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K033908 | N High Sensitivity CRPSummary page 5…Special 510(k) CardioPhase hsCRP Change in Reference Standard Material 3. Legally Marketed Unmodified / Predicate Devices Cleared for use on Siemens’ BN Systems under K033908 on January 22, 2004 as an in- vitro diagnostic reagent for the quantitative determination of C‑reactive protein (CRP) in human se… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | 2024 | 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?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 18.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K233242 (Siemens Healthcare Diagnostics, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K033908.
How does its category compare?
All NQD devicesNQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NQD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NQD
59in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQD
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQD
2in 2025
MAUDE reports naming product code NQD, 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 | 3 | 59 | 0 | 1 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 2 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
CardioPhase® hsCRP is an in-vitro diagnostic reagent for the quantitative determination of C‑reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using the BN II and BN ProSpec® System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury…
Read the full statement (135 words)
CardioPhase® hsCRP is an in-vitro diagnostic reagent for the quantitative determination of C‑reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using the BN II and BN ProSpec® System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212559 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212559: CardioPhase® hsCRP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212559
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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