510(k) · Cleared
Recalled · Class II · 2015Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, Dilpak
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 May 4, 2006 as substantially equivalent to K033908 (Dade Behring, Inc., 2004) after an 80-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it. It has been recalled once.
- Decided
- May 4, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- NQD
- Recalls
- 1
- 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 deviceK060369 Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, DilpakDade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK062924 Stratus CS Acute Care Cardiophase Hscrp TestpakDade Behring, Inc. · 2006 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K062924Stratus CS Acute Care Cardiophase Hscrp TestpakDade Behring, Inc. · 2006 · 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) | K060369 | Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, Dilpak | Dade Behring, Inc. | 2006 | — |
| +1 | K062924 | Stratus CS Acute Care Cardiophase Hscrp Testpak | Dade Behring, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K033908 | N High Sensitivity CRPSummary page 1…Immunology (81) Product Code: NQD; JIT 3. Identification of the Legally Marketed Device: Dade Behring CardioPhase hsCRP- K033908 oo100v Dade Behring… | 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 |
|---|---|---|---|
| K062924 | Stratus CS Acute Care Cardiophase Hscrp Testpak | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2015 | Class II | Z-0616-2016 | Labeling design | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 4.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062924 (Dade Behring, Inc., 2006) 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.
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?
The Stratus® CS Acute Care™ CardioPhase® hsCRP assay is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. 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…
Read the full statement (200 words)
The Stratus® CS Acute Care™ CardioPhase® hsCRP assay is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. 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.
The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP Calibrator, is an in vitro diagnostic product intended to be used for calibration of the Acute Care™ CardioPhase® method on the Stratus® CS analyzer.
The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP Dilution Pak, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ CardioPhase® hsCRP TestPak, for the measurement of samples with elevated levels of C-reactive protein.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060369 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060369: Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, Dilpak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060369
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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