510(k) · Cleared
ClearedSpife LD Vis Isoenzyme Kit, Models 3450, 3451, and 3452
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helena Laboratories · CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
Cleared on Mar 29, 2002 after a 45-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 29, 2002
- Review
- 45 days
- Class
- Class II
- Product code
- CFE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFE? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All CFE devicesCFE Electrophoretic, Lactate Dehydrogenase Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFE
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · CFE
Too few CFE 510(k)s in any year since 2007 to give a median.
Recalls per year · CFE
No recall names CFE since 2007.
Adverse event reports per year · CFE
No MAUDE report names CFE since 2007.
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 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 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 SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause.
The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion.
Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020467: Spife LD Vis Isoenzyme Kit, Models 3450, 3451, and 3452.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020467
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026