510(k) · Cleared
ClearedLactane Dehydrogenase-SL Assay, Catalogue Number 327-10, 327-30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Chemicals, Ltd. · CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Cleared on Jan 22, 1998 after a 24-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 22, 1998
- Review
- 24 days
- Class
- Class II
- Product code
- CFJ
- 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 CFJ? 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 CFJ devicesCFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFJ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · CFJ
Too few CFJ 510(k)s in any year since 2007 to give a median.
Recalls per year · CFJ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFJ
12in 2025
MAUDE reports naming product code CFJ, 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 1 | 10 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the quantitative determination of Lactate Dehydrogenase in serum. For IN VITRO diagnostic use. Elevated levels of lactate dehydrogenase are clinically significant and can be found in disease states which result in cell damage. Myocardial infarcts, liver disease, megaloblastic anemias, renal disease, progressive muscular dystrophy and some malignancies all produce elevated lactate dehydrogenase values in serum (1). Wacker et.al. (2) published a method…
Read the full statement (170 words)
For the quantitative determination of Lactate Dehydrogenase in serum. For IN VITRO diagnostic use. Elevated levels of lactate dehydrogenase are clinically significant and can be found in disease states which result in cell damage. Myocardial infarcts, liver disease, megaloblastic anemias, renal disease, progressive muscular dystrophy and some malignancies all produce elevated lactate dehydrogenase values in serum (1).
Wacker et.al. (2) published a method for the measurement of lactate dehydrognase (LDH) utilizing lactate as the substrate and nicotinamide adenine dinucleotide (NAD) as the indicator coenzyme. The use of the reverse reaction, pyruvate to lactate (LDH-P), has been described by Wroblewski and LaDue (3). Amador et.al. (4) claim the lactate to pyruvate (LDH-L) method is the method of choice because of the greater linearity of the reaction and improved stability of the reagents involved. The LDH-L reaction has been further studied by Gay et.al. (5) and the optimum reaction conditions outlined. This procedure uses the LDH-L method of Wacker in accordance with the recomendations of the International Federation of Clinical Chemists (6).
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/K974859 · printed Nov 3, 2026
Cite this page
510(k) Report. “K974859: Lactane Dehydrogenase-SL Assay, Catalogue Number 327-10, 327-30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K974859
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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