Piccolo Xpress Military Deployment Kit

Basic Information

• Brand Name: Piccolo Xpress Military Deployment Kit
• Primary DI: EABA11001511
• Version / Model: 1100-1511
• Catalog Number: 1100-1511
• Company Name: ABAXIS, INC.
• Labeler DUNS: 555503770
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c917a221-5f1b-43a0-ab1b-3890b1ab7487

Device Description

The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood, heparinized plasma, or serum. This kit contains additional accessories for supporting US military requirements. The Piccolo Xpress is a portable clinical chemistry system designed for accurate, on-site patient testing. It allows healthcare practitioners to perform routine multi-chemistry panels using 0.1cc of whole blood, serum or plasma. The system uses patented single-use reagent discs which contain up to 14 chemistry tests. Simply pipette the sample into the disc, insert the disc into the analyzer and results are printed or transferred to an LIS/EMR in about 12 minutes. No operator intervention is required. The Piccolo Xpress employs on-board continuous intelligent Quality Control (iQC®) to monitor the analyzer, reagent reactions and sample to ensure the highest quality and accuracy in results.

Device Characteristics

• Single Use: No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJG	Analyzer, Chemistry, Centrifugal, For Clinical Use	Clinical Chemistry	862.2140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35744	Centrifugal clinical chemistry analyser	A mains electricity (AC-powered) automatic or semi-automated instrument that uses centrifugal force to transfer and mix liquids. It also monitors the resulting reactions in the centrifuge with, e.g., a photometer. A separate unit is required for dispensing samples and reagents.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EABA11001511	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K934592	000

Device Sizes

Type	Value	Unit	Text
Height	32.5	Centimeter
Width	14.9	Centimeter
Depth	21.0	Centimeter
Weight	5.3	Kilogram

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 32 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 59 – 90 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 8 – 80 Percent (%) Relative Humidity