510(k) · Cleared
ClearedQuantech Myoglobin Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hellen Professional Services · MVE Biosensor, Immunoassay, Myoglobin
Cleared on Jun 29, 1998 as substantially equivalent to K915850 (Pb Diagnostic Systems, Inc., 1992) after a 61-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jun 29, 1998
- Review
- 61 days
- Class
- Class II
- Product code
- MVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915850 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK915850 Opus Myoglobin Test SystemPb Diagnostic Systems, Inc. · 1992
- This deviceK981536 Quantech Myoglobin AssayHellen Professional Services · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915850 | Opus Myoglobin Test System | Pb Diagnostic Systems, Inc. | 1992 | — |
| 0 (this device) | K981536 | Quantech Myoglobin Assay | Hellen Professional Services | 1998 | — |
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 MVE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K915850 | Opus Myoglobin Test SystemSummary page 2…asure the myoglobin in serum. 8.1 k] Comparison of Technological Characteristics The Quantech Myoglobin Assay is similar to the Opus® Myogiobin assay (K915850) as follows. Both assays are in vitro immunological assays for the quantitative measurement of human myoglobin. Additionally, bot… | 1992 |
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.
How does its category compare?
All MVE devicesMVE Biosensor, Immunoassay, Myoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVE
FDA has decided no MVE device since 2007.
Median 510(k) review, days · MVE
Too few MVE 510(k)s in any year since 2007 to give a median.
Recalls per year · MVE
No recall names MVE since 2007.
Adverse event reports per year · MVE
1in 2012
MAUDE reports naming product code MVE, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Quantech Myoglobin Assay is intended to be used as an aid in diagnosing myocardial infarction in patients exhibiting chest pain. It is intended to be used in conjunction with-EKG, and physician examination, as well as possibly other biochemical blood tests to rule in or out non-cardiac damaging origin of the chest pain.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981536: Quantech Myoglobin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981536
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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