Piccolo Renal Function Panel

Basic Information

• Brand Name: Piccolo Renal Function Panel
• Primary DI: EABA40000271
• Version / Model: 400-0027
• Catalog Number: 400-0027
• Company Name: ABAXIS, INC.
• Labeler DUNS: 555503770
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2025-08-18
• Public Version Status: Update
• Public Device Record Key: 612ebccb-5540-4e14-a700-abd99e6fb716

Device Description

The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	862.1580	1
CHJ	Mercuric Thiocyanate, Colorimetry, Chloride	Clinical Chemistry	862.1170	2
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	862.1665	2
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	862.1160	2
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	862.1600	2
CJY	Azo Dye, Calcium	Clinical Chemistry	862.1145	2
CDN	Urease, Photometric, Urea Nitrogen	Clinical Chemistry	862.1770	2
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	862.1225	2
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	862.1035	2
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52873	Bicarbonate (HCO3-) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of bicarbonate (HCO3-) in a clinical specimen.	No	Obsolete
52875	Calcium (Ca2+) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of calcium (Ca2+) in a clinical specimen.	No	Active
52879	Chloride (Cl-) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of chloride (Cl-) in a clinical specimen.	No	Active
52891	Inorganic phosphate (PO43-) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen.	No	Active
52895	Potassium (K+) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of potassium (K+) in a clinical specimen.	No	Active
52898	Sodium (Na+) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of sodium (Na+) in a clinical specimen.	No	Active
53252	Creatinine IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.	No	Active
53307	Glucose IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.	No	Active
53590	Urea IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.	No	Active
53599	Albumin IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of albumin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EABA40000271	HIBCC
Unit of Use	EABA40000270	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K010670	000
K022312	000
K934592	000
K942782	000
K950164	000
K992140	000
K993211	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 46 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius