510(k) · Cleared
ClearedImmulite Myoglobin, Model LKMY1 and LKMY5
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 Nov 25, 1998 as substantially equivalent to K974325 (Chiron Diagnostics Corp., 1997) after a 16-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Nov 25, 1998
- Review
- 16 days
- Class
- Class II
- Product code
- DDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974325 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK974325 Chiron Diagnostics Acs:180 MyoglobinChiron Diagnostics Corp. · 1997
- This deviceK983970 Immulite Myoglobin, Model LKMY1 and LKMY5Diagnostic Products Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974325 | Chiron Diagnostics Acs:180 Myoglobin | Chiron Diagnostics Corp. | 1997 | — |
| 0 (this device) | K983970 | Immulite Myoglobin, Model LKMY1 and LKMY5 | Diagnostic Products Corp. | 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 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 |
|---|---|---|---|
| * | K974325 | Chiron Diagnostics Acs:180 MyoglobinSummary page 1…alifornia 90045-5597 Diagnostic Products Corporation 5700 West 96™ Street Los Angeles, California 90045-5597 DPC’s Registration Number 1s 2017183 ACS: 180 Myoglobin (K974325) Manufactured by Chiron Diagnostics IMMULITE® Myoglobin is a clinical device for use with the IMMULITE® Automated Immunoassay An… | 1997 |
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.
- 2 other devices also cite its predicate K974325.
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® 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. It is intended strictly for in vifro 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/K983970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983970: Immulite Myoglobin, Model LKMY1 and LKMY5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983970
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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