Piccolo AmLyte 13

Basic Information

• Brand Name: Piccolo AmLyte 13
• Primary DI: EABA40000411
• Version / Model: 400-0041
• Catalog Number: 400-0041
• 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: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 357ce95c-2cbf-4212-8a02-9b7122561618

Device Description

The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement.

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
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	862.1100	2
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	862.1110	2
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	862.1035	2
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	862.1225	2
CDN	Urease, Photometric, Urea Nitrogen	Clinical Chemistry	862.1770	2
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	862.1030	1
CIJ	Saccharogenic, Amylase	Clinical Chemistry	862.1070	2
CJY	Azo Dye, Calcium	Clinical Chemistry	862.1145	2
JLB	Atp And Creatine Kinase (Enzymatic), Creatine	Clinical Chemistry	862.1210	1
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	862.1600	2
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	862.1665	2
DCN	System, Test, C-Reactive Protein	Immunology	866.5270	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52955	Total aspartate aminotransferase (AST) 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 total aspartate aminotransferase (AST) 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
53231	Total bilirubin 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 total bilirubin in a clinical specimen.	No	Active
53599	Albumin 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 albumin 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
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
52925	Alanine aminotransferase (ALT) 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 alanine aminotransferase (ALT) in a clinical specimen.	No	Active
52941	Total amylase 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 total amylase in a clinical specimen.	No	Active
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
53006	Total creatine kinase (CK) 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 total creatine kinase (CK) 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
53707	C-reactive protein (CRP) 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 C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EABA40000411	HIBCC
Unit of Use	EABA40000410	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091052	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