510(k) · Cleared
ClearedN High Sensitivity CRP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Jan 22, 2004 as substantially equivalent to K991385 (Dade Behring, Inc., 1999) after a 36-day review. Its family tree reaches back 1 generation to 1999. 23 later devices descend from it.
- Decided
- Jan 22, 2004
- Review
- 36 days
- Class
- Class II
- Product code
- NQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991385 (1999). 23 later devices descend from it, 11 citing it directly.
- Root · 1 generation backK991385 Dade Behring N High Sensitivity CRP AssayDade Behring, Inc. · 1999
- This deviceK033908 N High Sensitivity CRPDade Behring, Inc. · 2004
- Descendant · cites it directly · 7 of its ownK042485 Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex)…Roche Diagnostics Corp. · 2004 · Recalled
- Descendant · 2 generations on · 3 of its ownK103557 Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011
- Descendant · cites it directly · 2 of its ownK053603 C-Reactive Protein (Latex) High Sensitive Test System for Cobas…Roche Diagnostics Corp. · 2006
- Descendant · cites it directly · 2 of its ownK041799 Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- Descendant · cites it directly · 1 of its ownK212559 CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH · 2022
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K042485Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)Roche Diagnostics Corp. · 2004 · cites it directly7descendants
- K103557Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011 · 2 generations on3descendants
- K053603C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra InstrumentsRoche Diagnostics Corp. · 2006 · cites it directly2descendants
- K041799Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17…Ortho-Clinical Diagnostics, Inc. · 2004 · cites it directly2descendants
- K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991385 | Dade Behring N High Sensitivity CRP Assay | Dade Behring, Inc. | 1999 | — |
| 0 (this device) | K033908 | N High Sensitivity CRP | Dade Behring, Inc. | 2004 | — |
| +1 | K042485 | Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High… | Roche Diagnostics Corp. | 2004 | 1 |
| +2 | K103557 | Diazyme HS CRP Assay Kit / Calibrator Set / Control Set | Diazyme Laboratories | 2011 | — |
| +1 | K053603 | C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra… | Roche Diagnostics Corp. | 2006 | — |
| +1 | K041799 | Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | 3 |
| +1 | K212559 | CardioPhase® hsCRP | Siemens Healthcare Diagnostics Products GmbH | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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
- #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 |
|---|---|---|---|
| * | K991385 | Dade Behring N High Sensitivity CRP AssaySummary page 1…tem, Class 11 (866.5270) Product Code: 81 NQD 3. Identification of the Legally Marketed Device: N High Sensitivity CRP - K991385 4. Device Description: Polystyrene particles coated with monoclonal antibodies to CRP are agglutinated when… | 1999 |
What descends from it? (23)
See all 2311 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042485 | Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) | 2004 | 7 |
| K053603 | C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra Instruments | 2006 | 2 |
| K041799 | Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17… | 2004 | 2 |
| K212559 | CardioPhase® hsCRP | 2022 | 1 |
| K070626 | Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent | 2007 | 1 |
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP | 2006 | 1 |
| K060369 | Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, Dilpak | 2006 | 1 |
| K081294 | Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), Calibrators | 2008 | 0 |
| K071002 | Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) Reagent | 2007 | 0 |
| K061802 | Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp… | 2006 | 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?
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.
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?
N High Sensitivity CRP 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 BNTM Systems. 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…
Read the full statement (130 words)
N High Sensitivity CRP 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 BNTM Systems. 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. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, 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/K033908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033908: N High Sensitivity CRP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033908
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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