510(k) · Cleared
ClearedPiccolo Lactate Dephydrogenase Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abaxis, Inc. · CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Cleared on Jul 8, 2005 as substantially equivalent to K011213 (Beckman Coulter, Inc., 2001) after a 67-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jul 8, 2005
- Review
- 67 days
- Class
- Class II
- Product code
- CFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011213 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011213 Modification to Synchron LX 20 Clinical Chemistry SystemBeckman Coulter, Inc. · 2001 · Recalled
- This deviceK051108 Piccolo Lactate Dephydrogenase Test SystemAbaxis, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011213 | Modification to Synchron LX 20 Clinical Chemistry System | Beckman Coulter, Inc. | 2001 | 11 |
| 0 (this device) | K051108 | Piccolo Lactate Dephydrogenase Test System | Abaxis, Inc. | 2005 | — |
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 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? (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 |
|---|---|---|---|
| * | K011213 | Modification to Synchron LX 20 Clinical Chemistry SystemSummary page 1…ermination Lactate Dehydrogenase 5/16/01 Reagents on the Beckman Coulter, K011213 Synchron LX20 Inc. (Brea, CA) Chemistry System 4. Description of the Device:… | 2001 |
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 a recall.
- 4 other devices also cite its predicate K011213.
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?
The Piccolo Lactate Dehydrogenase Test System (presently contained on the Piccolo Basic Metabolic Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate dehydrogenase activity in heparinized plasma or serum in a clinical laboratory setting or point-of-care location.
Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis and cirrhosis; cardiac diseases such as myocardial infarction; and tissue alterations of the heart, kidney, liver, and muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051108 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051108: Piccolo Lactate Dephydrogenase Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051108
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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