510(k) · Cleared
ClearedPiccolo Trglycerides-Capillary 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 Apr 24, 2012 as substantially equivalent to K023639 (Abaxis, Inc., 2003) and 1 other predicate after a 50-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Apr 24, 2012
- Review
- 50 days
- Class
- Class I
- Product code
- JGY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K854152 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854152 | Technicon RA Systems for Triglycerides Analysis in | Technicon Instruments Corp. | 1985 | — |
| −1 | K023639 | Piccolo Triglycerides Test System | Abaxis, Inc. | 2003 | — |
| 0 (this device) | K120664 | Piccolo Trglycerides-Capillary Test System | Abaxis, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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? (2)
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 |
|---|---|---|---|
| * | K023639 | Piccolo Triglycerides Test SystemSummary page 1…________________ Number Determination Piccolo® Triglycerides Abaxis K023639 1/24/2003 Test System Union City, CA Cobas® Triglycerides R… | 2003 |
| * | K893973 | Roche Reagent for TriglyceridesSummary page 1…K023639 1/24/2003 Test System Union City, CA Cobas® Triglycerides Roche Diagnostics K893973 08/11/1989 Test Indianapolis, IN Abaxis Confidential… | 1989 |
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?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 17.2 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K023639.
How does its category compare?
All JGY devicesJGY Colorimetric Method, Triglycerides: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
The Piccolo Triglycerides - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.
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/K120664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120664: Piccolo Trglycerides-Capillary Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120664
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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