510(k) · Cleared
Recalled · Class II · 2019Tina-Quant Myoglobin Gen.2 Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Jul 21, 2006 as substantially equivalent to K972513 (Boehringer Mannheim Corp., 1997) after a 36-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 21, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- DDR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902154 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK902154 NA Latex Myoglobin TestBehring Diagnostics, Inc. · 1990
- 1 generation backK972513 Tinaquant Myoglobin AssayBoehringer Mannheim Corp. · 1997
- This deviceK061683 Tina-Quant Myoglobin Gen.2 Test SystemRoche Diagnostics Corp. · 2006
- Descendant · cites it directly · 0 of its ownK123785 Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories · 2013
Most influential descendants
Showing 1 of 1 · See all- K123785Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902154 | NA Latex Myoglobin Test | Behring Diagnostics, Inc. | 1990 | — |
| −1 | K972513 | Tinaquant Myoglobin Assay | Boehringer Mannheim Corp. | 1997 | — |
| 0 (this device) | K061683 | Tina-Quant Myoglobin Gen.2 Test System | Roche Diagnostics Corp. | 2006 | — |
| +1 | K123785 | Diazyme Myoglobin; Assay, Calibrator Set, Control Set | Diazyme Laboratories | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | K972513 | Tinaquant Myoglobin AssaySummary page 1…nt® Myoglobin Gen.2 test system is substantially equivalent to devices the currently marketed Tina-Quant ®9 Myoglobin Test System cleared under K9725 13. Device The Tina-Quant®V Gen.2 Test System is an immunoturbidimetric assay for the Description quantitative in v… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123785 | Diazyme Myoglobin; Assay, Calibrator Set, Control Set | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2019 | Class II | Z-2445-2019 | Under Investigation by firm | The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant Myoglobin Gen.2 assay (catalog number 04580010190), lot number 349860 on the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K123785 (Diazyme Laboratories, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K972513.
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?
The Tina-Quant ® Myoglobin Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.
C.f.a.s. (Calibrator for automated systems) Myoglobin is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061683 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061683: Tina-Quant Myoglobin Gen.2 Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061683
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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