510(k) · Cleared
ClearedPiccolo Triglycerides Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abaxis, Inc. · JGY Colorimetric Method, Triglycerides
Cleared on Jan 24, 2003 as substantially equivalent to K854152 (Technicon Instruments Corp., 1985) after an 86-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Jan 24, 2003
- Review
- 86 days
- Class
- Class I
- Product code
- JGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854152 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK854152 Technicon RA Systems for Triglycerides Analysis inTechnicon Instruments Corp. · 1985
- This deviceK023639 Piccolo Triglycerides Test SystemAbaxis, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK251091 LipidsTruvian Health · 2025
- Descendant · cites it directly · 0 of its ownK120664 Piccolo Trglycerides-Capillary Test SystemAbaxis, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854152 | Technicon RA Systems for Triglycerides Analysis in | Technicon Instruments Corp. | 1985 | — |
| 0 (this device) | K023639 | Piccolo Triglycerides Test System | Abaxis, Inc. | 2003 | — |
| +1 | K251091 | Lipids | Truvian Health | 2025 | — |
| +1 | K120664 | Piccolo Trglycerides-Capillary Test System | Abaxis, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2025 | 1 | 0 |
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 JGY? 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 |
|---|---|---|---|
| * | K854152 | Technicon RA Systems for Triglycerides Analysis inSummary page 1…e following table identifies the legally marketed device to which Abaxis claims equivalence: T r i g l ycerides-RA Bayer Diagnostics K854152* 1 1/5/85 Assay Run on a Hitachi 917 Clinical (Technicon… | 1985 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K251091 (Truvian Health, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JGY devicesJGY Colorimetric Method, Triglycerides: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JGY
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JGY
Too few JGY 510(k)s in any year since 2007 to give a median.
Recalls per year · JGY
No recall names JGY since 2007.
Adverse event reports per year · JGY
1in 2021
MAUDE reports naming product code JGY, 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 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 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 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023639 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023639: Piccolo Triglycerides 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/K023639
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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