510(k) · Cleared
Recalled · Class II · 2018Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range Verifiers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Nov 5, 2003 as substantially equivalent to K984191 (Dade Behring, Inc., 1998) and 1 other predicate after a 22-day review. Its family tree reaches back 2 generations to 1997. It has been recalled once.
- Decided
- Nov 5, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- DDR
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973517 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK973517 Vitros Immunodiagnostic Products Range VerifiersJohnson & Johnson Clinical Diagnostics, Inc. · 1997
- 1 generation backK992349 Vitros Immunodiagnostic Products Troponin I Range VerifiersOrtho-Clinical Diagnostics, Inc. · 1999
- This deviceK033300 Vitros Immunodiagnostic Products Myoglobin Reagent Pack…Ortho-Clinical Diagnostics, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973517 | Vitros Immunodiagnostic Products Range Verifiers | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | — |
| −1 | K992349 | Vitros Immunodiagnostic Products Troponin I Range Verifiers | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| 0 (this device) | K033300 | Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range… | Ortho-Clinical Diagnostics, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 DDR? 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 DDR device
- #1 K231832 Access Myoglobinscore 6.3 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K984191 | Myoglobin Flex Reagent CartridgeSummary page 3…ally Predicate device: equivalent to the DADE Dimension RxL Myoglobin (MYO) Method (predicate device) which was cleared by the FDA (K984191) for IVD use. Calibrators The relationship between the Vitros Myoglobin and the predicate device,… | 1998 |
| * | K992349 | Vitros Immunodiagnostic Products Troponin I Range VerifiersSummary page 4…mparison to substantially equivalent to the Vitros Troponin I Range Verifiers (predicate predicate device) which was cleared by the FDA (K992349) for IVD use. device: Range Verifiers Table 2 lists the similarities and differences of… | 1999 |
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 29, 2018 | Class II | Z-0844-2019 | Under Investigation by firm | A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 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.
- 1 other device also cites its predicate K984191.
How does its category compare?
All DDR devicesDDR Myoglobin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DDR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DDR
Too few DDR 510(k)s in any year since 2007 to give a median.
Recalls per year · DDR
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DDR
5in 2025
MAUDE reports naming product code DDR, 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 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 2 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 31 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the in vitro quantitative measurement of myoglobin concentration in human serum or plasma (EDTA or heparin) to aid in the diagnosis of myocardial infarction.
For in vitro use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of Myoglobin in human serum and plasma (EDTA or heparin).
Assayed for use in verifying the calibration range of the Vitros Immunodiagnostic System when used for the measurement of Myoglobin. For in vitro use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033300: Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033300
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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