# K950164: Piccolo (TM) Primary Health Panel Reagent Rotor

- Pathway: 510(k) (Traditional)
- Applicant: Abaxis, Inc.
- Decided: Apr 13, 1995 after 86 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K171971: Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (2018), 2 descendants of its own
- K251157: Core Metabolic (2026), 0 descendants of its own
- K251074: Tru Liver Health Test Panel (2025), 0 descendants of its own
- K251058: Tru Kidney Health Test Panel; Tru Analyzer (2025), 0 descendants of its own

## Recalls of this device
- Nov 19, 2010 · Not classified · Z-1066-2011: 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 xpr

Source page: https://510kreport.com/device/K950164
Methodology: https://510kreport.com/methodology