510(k) · Cleared
ClearedImmulite Turbo Myoglobin, Models LSKMY1, LSKMY5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · DDR Myoglobin, Antigen, Antiserum, Control
Cleared on Jun 9, 1999 after a 14-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Jun 9, 1999
- Review
- 14 days
- Class
- Class II
- Product code
- DDR
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK991796 Immulite Turbo Myoglobin, Models LSKMY1, LSKMY5Diagnostic Products Corp. · 1999
- Descendant · cites it directly · 0 of its ownK034055 Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991796 | Immulite Turbo Myoglobin, Models LSKMY1, LSKMY5 | Diagnostic Products Corp. | 1999 | — |
| +1 | K034055 | Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin I | Diagnostic Products Corp. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K034055 | Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin I | 2004 | 0 |
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?
- Of its descendants, K034055 (Diagnostic Products Corp., 2004) has gone furthest, with 0 descendants of its own.
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?
IMMULITE® Turbo Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of myoglobin in serum or heparinized plasma. It is intended strictly for in vitro use as an aid in the diagnosis of acute myocardial infarction (AMI):
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/K991796 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991796: Immulite Turbo Myoglobin, Models LSKMY1, LSKMY5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991796
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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