510(k) · Cleared
Recalled · Class II · 2020Lactate Dehydrogenase (LD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Cleared on May 7, 1997 after a 72-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 2 times.
- Decided
- May 7, 1997
- Review
- 72 days
- Class
- Class II
- Product code
- CFJ
- Recalls
- 2
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2020 | Class II | Z-2963-2020 | Under Investigation by firm | An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the… |
| Aug 11, 2020 | Class II | Z-2962-2020 | Under Investigation by firm | An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the… |
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 | — |
https://510kreport.com/device/K970684 · printed Nov 3, 2026
Cite this page
510(k) Report. “K970684: Lactate Dehydrogenase (LD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K970684
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026