510(k) · Cleared
Recalled · Class II · 2017Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17, Vitros Chemistry Products FS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Aug 25, 2004 as substantially equivalent to K033908 (Dade Behring, Inc., 2004) and 1 other predicate after a 54-day review. Its family tree reaches back 2 generations to 1999. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 25, 2004
- Review
- 54 days
- Class
- Class II
- Product code
- NQD
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K991385 (1999). 3 ancestors in all, the oldest K953197 (1995). 2 later devices descend from it, 2 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 deviceK041799 Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK141689 FastPack High Sensitivity C-Reactive Protein Immunoassay, High…Qualigen, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK042838 Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry…Ortho-Clinical Diagnostics, Inc. · 2004
Most influential descendants
Showing 2 of 2 · See all- K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…Qualigen, Inc. · 2015 · cites it directly0descendants
- K042838Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb Performance…Ortho-Clinical Diagnostics, Inc. · 2004 · 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) | K041799 | Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
| +1 | K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity… | Qualigen, Inc. | 2015 | — |
| +1 | K042838 | Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2015 | 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 3…VITROS Chemistry Products FS Calibrator 1 are substantially equivalent to the N High Sensitivity CRP Assay (Dade Behring, Inc.), which was cleared by FDA (K033908) for IVD use. The relationship between the VITROS hsCRP assay and the predicate device, determined by least square… | 2004 |
| * | K953197 | Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP)Summary page 4…P Performance Verifiers are substantially equivalent to VITROS Chemistry Products CRP Performance Verifiers (predicate device) which were cleared by the FDA (K953197) for 1VD use. The table below lists the characteristics of the VITROS Chemistry Products hsCRP Performance Verifier… | 1995 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2017 | Class III | Z-1181-2017 | Under Investigation by firm | The company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL Reagent when using VITROS FS Calibrator 1, Lot 91461 and ADD (DRV 5908). Assay Data Disk (ADD) DRV versions 5904, 5905, 5906, 5907… |
| May 12, 2014 | Class II | Z-1804-2014 | Process change control | Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator… |
| May 12, 2014 | Class II | Z-1805-2014 | Process change control | Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K141689 (Qualigen, Inc., 2015) 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?
For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Reagent is used to quantitatively measure C-reactive protein (CRP) in human serum and plasma. CRP is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with values of CRP that exceed 3 mg/L. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to…
Read the full statement (120 words)
For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Reagent is used to quantitatively measure C-reactive protein (CRP) in human serum and plasma. CRP is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with values of CRP that exceed 3 mg/L.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.
For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Performance Verifiers are assayed controls used to monitor performance of hsCRP Reagent on VITROS 5,1 FS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041799: Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17, Vitros Chemistry Products FS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041799
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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