510(k) · Cleared
Recalled · 2010Piccolo (TM) Primary Health Panel Reagent Rotor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abaxis, Inc. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Apr 13, 1995 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Apr 13, 1995
- Review
- 86 days
- Class
- Class I
- Product code
- CHH
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK950164 Piccolo (TM) Primary Health Panel Reagent RotorAbaxis, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK171971 Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer…Lite-On Technology Corp. H.S.P.B. · 2018
- Descendant · cites it directly · 0 of its ownK251157 Core MetabolicTruvian Health · 2026
- Descendant · 2 generations on · 0 of its ownK251074 Tru Liver Health Test PanelTruvian Health · 2025
- Descendant · 2 generations on · 0 of its ownK251058 Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025
Most influential descendants
Showing 4 of 4 · See all- K171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical…Lite-On Technology Corp. H.S.P.B. · 2018 · cites it directly2descendants
- K251157Core MetabolicTruvian Health · 2026 · cites it directly0descendants
- K251074Tru Liver Health Test PanelTruvian Health · 2025 · 2 generations on0descendants
- K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950164 | Piccolo (TM) Primary Health Panel Reagent Rotor | Abaxis, Inc. | 1995 | — |
| +1 | K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare… | Lite-On Technology Corp. H.S.P.B. | 2018 | — |
| +1 | K251157 | Core Metabolic | Truvian Health | 2026 | — |
| +2 | K251074 | Tru Liver Health Test Panel | Truvian Health | 2025 | — |
| +2 | K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
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 CHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2010 | Not classified | Z-1066-2011 | Other | Abaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of Alanine Aminotransferase (ALT) when used in the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K171971 (Lite-On Technology Corp. H.S.P.B., 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K950164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950164: Piccolo (TM) Primary Health Panel Reagent Rotor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950164
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026