510(k) · Cleared
Recalled · Class II · 2015Stratus CS Acute Care Cardiophase Hscrp Testpak
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 Dec 26, 2006 as substantially equivalent to K060369 (Dade Behring, Inc., 2006) after an 89-day review. Its family tree reaches back 3 generations to 1999. It has been recalled once.
- Decided
- Dec 26, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- NQD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K991385 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK991385 Dade Behring N High Sensitivity CRP AssayDade Behring, Inc. · 1999
- 2 generations backK033908 N High Sensitivity CRPDade Behring, Inc. · 2004
- 1 generation backK060369 Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, DilpakDade Behring, Inc. · 2006 · Recalled
- This deviceK062924 Stratus CS Acute Care Cardiophase Hscrp TestpakDade Behring, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991385 | Dade Behring N High Sensitivity CRP Assay | Dade Behring, Inc. | 1999 | — |
| −2 | K033908 | N High Sensitivity CRP | Dade Behring, Inc. | 2004 | — |
| −1 | K060369 | Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, Dilpak | Dade Behring, Inc. | 2006 | 1 |
| 0 (this device) | K062924 | Stratus CS Acute Care Cardiophase Hscrp Testpak | Dade Behring, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K060369 | Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, DilpakSummary page 1…estPak /Class II 3. Identification of the Predicate Device *Dade Behring Stratus® CS Acute CareTM CardioPhase®hsCRP TestPak K060369 4. Device Description(s): The Stratus® CS Acute Care~h CardioPhase®&… | 2006 |
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 |
|---|---|---|---|---|
| Nov 11, 2015 | Class II | Z-0614-2016 | 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 2.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
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 Tm CardioPhase®hsCRP method is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful…
Read the full statement (146 words)
The Stratus® CS Acute Care Tm CardioPhase®hsCRP method is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
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/K062924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062924: Stratus CS Acute Care Cardiophase Hscrp Testpak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062924
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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