510(k) · Cleared
ClearedPiccolo HDL-Capillary Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abaxis, Inc. · JHM Colorimetric Method, Lipoproteins
Cleared on Apr 24, 2012 as substantially equivalent to K023640 (Abaxis, Inc., 2003) and 1 other predicate after a 50-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Apr 24, 2012
- Review
- 50 days
- Class
- Class I
- Product code
- JHM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902935 (1990). 4 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 | K902935 | Roche Cobas Ready HDL Cholesterol Reagent | Roche Diagnostic Systems, Inc. | 1990 | — |
| −1 | K023640 | Piccolo HDL Test System | Abaxis, Inc. | 2003 | — |
| 0 (this device) | K120662 | Piccolo HDL-Capillary Test System | Abaxis, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 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 JHM? 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 |
|---|---|---|---|
| * | K023640 | Piccolo HDL Test SystemSummary page 1…Predicate, Device Manufacturer 510(k) Number Date of SE Determination Piccolo® HDL Test Abaxis K023640 1/24/2003 System Cobas® HDL- Roche Diagnostics K033610… | 2003 |
| * | K033610 | HDL-Cholesterol Plus 2ND GenerationSummary page 1…HDL Test Abaxis K023640 1/24/2003 System Cobas® HDL- Roche Diagnostics K033610 12/05/2003 Cholesterol Plus 3 rd Indianapolis, IN Generation Abaxis Con… | 2003 |
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 22 years and passes through 2 companies; a new generation was cleared every 12.3 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All JHM devicesJHM Colorimetric Method, Lipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JHM
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JHM
Too few JHM 510(k)s in any year since 2007 to give a median.
Recalls per year · JHM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHM
No MAUDE report names JHM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 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 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Piccolo HDL - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.
Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120662 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120662: Piccolo HDL-Capillary 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/K120662
Report an extraction error
Are you the manufacturer?
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