510(k) · Cleared
ClearedSynchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on May 4, 2007 as substantially equivalent to K033908 (Dade Behring, Inc., 2004) and 1 other predicate after a 59-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- May 4, 2007
- Review
- 59 days
- Class
- Class II
- Product code
- NQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K991385 (1999). 3 ancestors in all. 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 deviceK070626 Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH)…Beckman Coulter, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK091052 Piccolo C-Reactive Protein (CRP) Test SystemAbaxis, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K091052Piccolo C-Reactive Protein (CRP) Test SystemAbaxis, Inc. · 2010 · 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) | K070626 | Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent | Beckman Coulter, Inc. | 2007 | — |
| +1 | K091052 | Piccolo C-Reactive Protein (CRP) Test System | Abaxis, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (2)
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…(Product Code) Synchron Systems Dade Behring Dade Behring K033908 High Sensitivity Cardiac CardioPhase hsCRP Inc.* (NOD) CRPH Reagent Synch… | 2004 |
| * | K010597 | Synchron LX Systems High Sensitivity C-Reactive Protien (CRPH) ReagentSummary page 1…rdiac CardioPhase hsCRP Inc.* (NOD) CRPH Reagent Synchron Systems Synchron Systems Beckman K010597 High Sensitivity Cardiac High Sensitivity Coulter, Inc (DCK) CRPH Reagent… | 2001 |
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 |
|---|---|---|---|
| K091052 | Piccolo C-Reactive Protein (CRP) Test System | 2010 | 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 8 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K091052 (Abaxis, Inc., 2010) 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. 2007, 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?
High Sensitivity Cardiac C-Reactive Protein (CRPH) reagent, when used in conjunction with SYNCHRON LX® PRO System, UniCel® DxC 600/800 System(s) and SYNCHRON® Systems CAL 5 Plus, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma by rate turbidimetry. Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Cardiac CRP assays are…
Read the full statement (119 words)
High Sensitivity Cardiac C-Reactive Protein (CRPH) reagent, when used in conjunction with SYNCHRON LX® PRO System, UniCel® DxC 600/800 System(s) and SYNCHRON® Systems CAL 5 Plus, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma by rate turbidimetry.
Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Cardiac CRP assays are indicated for use as an aid in the identification and stratification of individuals at risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, CRP may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070626: Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070626
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