510(k) · Cleared
ClearedDiazyme HS CRP Assay Kit / Calibrator Set / Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Apr 27, 2011 as substantially equivalent to K042485 (Roche Diagnostics Corp., 2004) after a 146-day review. Its family tree reaches back 4 generations to 1989. 3 later devices descend from it.
- Decided
- Apr 27, 2011
- Review
- 146 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K895880 (1989). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK895880 Pancreatic a-Amylase EpsBoehringer Mannheim Corp. · 1989
- 3 generations backK981897 Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent…Roche Diagnostic Systems, Inc. · 1998
- 2 generations backK003400 CRP HS Test SystemRoche Diagnostics Corp. · 2001
- 1 generation backK042485 Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex)…Roche Diagnostics Corp. · 2004 · Recalled
- This deviceK103557 Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDiazyme Laboratories · 2011
- Descendant · cites it directly · 1 of its ownK160712 VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics · 2017
- Descendant · 2 generations on · 0 of its ownK191993 Yumizen C1200 CRPHoriba Abx Sas · 2019
- Descendant · cites it directly · 0 of its ownK121558 Diazyme Hscrp Poc Test KitDiazyme Laboratories · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895880 | Pancreatic a-Amylase Eps | Boehringer Mannheim Corp. | 1989 | — |
| −3 | K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche… | Roche Diagnostic Systems, Inc. | 1998 | — |
| −2 | K003400 | CRP HS Test System | Roche Diagnostics Corp. | 2001 | — |
| −1 | K042485 | Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High… | Roche Diagnostics Corp. | 2004 | 1 |
| 0 (this device) | K103557 | Diazyme HS CRP Assay Kit / Calibrator Set / Control Set | Diazyme Laboratories | 2011 | — |
| +1 | K160712 | VITROS Chemistry Products hsCRP Reagent | Ortho Clinical Diagnostics | 2017 | — |
| +2 | K191993 | Yumizen C1200 CRP | Horiba Abx Sas | 2019 | — |
| +1 | K121558 | Diazyme Hscrp Poc Test Kit | Diazyme Laboratories | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 DCK? 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 DCK device
- #1 K242170 K-ASSAY CRP (Ver.2)score 9.2 · 1 generation · 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 |
|---|---|---|---|
| * | K042485 | Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)Summary page 3…set is intended for use as quality controls for the Diazyme hsCRP assay. For in vitro diagnostic use only. Table I Summary of Assay Kit Components Roche Tina-Quant CRP k042485 Diazyme hsCRP Assay Reagent 1 Reagent I buffer solution, rea… | 2004 |
| † | K011226 | Calibrator for Automated Systems | 2001 |
| † | K982087 | Roche CRP T Control N | 1998 |
| † | K871027 | Precinorm (R) Protein | 1987 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K160712 (Ortho Clinical Diagnostics, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K042485.
How does its category compare?
All DCK devicesDCK C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DCK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DCK
Too few DCK 510(k)s in any year since 2007 to give a median.
Recalls per year · DCK
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCK
1in 2021
MAUDE reports naming product code DCK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Diazyme high sensitivity C-reactive protein (hsCRP) assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only.
The Diazyme hsCRP assay calibrator set is intended for use in the calibration of the C-reactive protein (CRP) assay. For in vitro diagnostic use only.
The Diazyme hsCRP assay control set is intended for use as quality controls for the Diazyme hsCRP assay. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103557: Diazyme HS CRP Assay Kit / Calibrator Set / Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103557
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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