510(k) · Cleared
ClearedQuantex Myoglobin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Dec 22, 2004 as substantially equivalent to K902154 (Behring Diagnostics, Inc., 1990) after a 54-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Dec 22, 2004
- Review
- 54 days
- Class
- Class II
- Product code
- DDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902154 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902154 NA Latex Myoglobin TestBehring Diagnostics, Inc. · 1990
- This deviceK042982 Quantex MyoglobinInstrumentation Laboratory CO · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902154 | NA Latex Myoglobin Test | Behring Diagnostics, Inc. | 1990 | — |
| 0 (this device) | K042982 | Quantex Myoglobin | Instrumentation Laboratory CO | 2004 | — |
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? (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 |
|---|---|---|---|
| * | K902154 | NA Latex Myoglobin TestSummary page 1…e(s): 866.5680 Myoglobin Immunological Test System Class II DDR Myoglobin, Antigen, Antiserum, Control Identification of predicate device(s): K902154 N Latex Myoglobin (Dade Behring) Description of the device/intended use(s): Quantex Myoglobin is intended as a latex parti… | 1990 |
| † | K040879 | Quantex Ferritin | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K902154.
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?
Quantex Myoglobin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of myoglobin concentration in human serum or plasma (EDTA or Lithium Heparin) on Clinical Chemistry Systems as an aid in the diagnosis of myocardial infarction. For in vitro diagnostic use. Quantex Ferritin / Myoglobin controls I/IL are intended for use in monitoring the quality control of results obtained with the quantex Myoglobin…
Read the full statement (114 words)
Quantex Myoglobin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of myoglobin concentration in human serum or plasma (EDTA or Lithium Heparin) on Clinical Chemistry Systems as an aid in the diagnosis of myocardial infarction. For in vitro diagnostic use.
Quantex Ferritin / Myoglobin controls I/IL are intended for use in monitoring the quality control of results obtained with the quantex Myoglobin reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879.) For in vitro diagnostic use.
Quantex Myoglobin standard multipoint is intended for use in establishing the calibration curve for the quantex Myoglobin reagents by turbidimetry. For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042982: Quantex Myoglobin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042982
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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