FDA.reportPublic FDA data

Piccolo Renal Function Panel

Primary DI
EABA40000271
Brand
Piccolo Renal Function Panel
Company
ABAXIS, INC.
Model
400-0027
Catalog number
400-0027
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.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDNUrease, Photometric, Urea Nitrogen
CEMElectrode, Ion Specific, Potassium
CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
CGAGlucose Oxidase, Glucose
CGXAlkaline Picrate, Colorimetry, Creatinine
CHJMercuric Thiocyanate, Colorimetry, Chloride
CJWBromcresol Purple Dye-Binding, Albumin
CJYAzo Dye, Calcium
JGSElectrode, Ion Specific, Sodium
KHSEnzymatic, Carbon-Dioxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDNUrease, Photometric, Urea NitrogenClinical Chemistry2
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CEOPhosphomolybdate (Colorimetric), Inorganic PhosphorusClinical Chemistry1
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGXAlkaline Picrate, Colorimetry, CreatinineClinical Chemistry2
CHJMercuric Thiocyanate, Colorimetry, ChlorideClinical Chemistry2
CJWBromcresol Purple Dye-Binding, AlbuminClinical Chemistry2
CJYAzo Dye, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
KHSEnzymatic, Carbon-DioxideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010670000
K022312000
K934592000
K942782000
K950164000
K992140000
K993211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010670000PICCOLO CHLORIDE TEST SYSTEMAbaxis, Inc.2001-04-26CHJ
K022312000PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.2002-09-05CEO
K934592000EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.1994-04-06JJG
K942782000PICCOLO(TM)Abaxis, Inc.1995-03-13JJG
K950164000PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTORAbaxis, Inc.1995-04-13CHH
K992140000PICCOLO METLYTE 7 REAGENT DISCAbaxis, Inc.1999-08-26JLB
K993211000PICCOLO SODIUM TEST SYSTEMAbaxis, Inc.1999-10-25JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EABA40000271PrimaryHIBCC0
EABA40000270Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Inorganic phosphate (PO43-) IVD, reagentA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit46 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-822-2947Piccolo@abaxis.com
+1 (510) 675 6500abaxis@abaxis.com
+496155780210abaxis@abaxis.de

Regulatory Flags#

DUNS number
555503770
Device count
10
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EABA40000031Piccolo Liver Panel Plus400-0003400-00032016-09-23
EABA40000261Piccolo Hepatic Function Panel400-0026400-00262016-09-23
EABA40000281Piccolo Comprehensive Metabolic Panel400-0028400-00282016-09-23
EABA40000291Piccolo General Chemistry 13400-0029400-00292016-09-23
EABA40000351Piccolo BioChemistry Panel Plus400-0035400-00352016-09-23
EABA40000371Piccolo MetLac 12 Panel400-0037400-00372016-09-23
EABA40000411Piccolo AmLyte 13400-0041400-00412016-09-23
EABA110000001Piccolo Xpress1100-00001100-00002016-09-23
EABA11001511Piccolo Xpress Military Deployment Kit1100-15111100-15112017-06-30
EABA40000061Piccolo General Chemistry 6400-0006400-00062016-09-23
EABA40000231Piccolo MetLyte 8 Panel400-0023400-00232016-09-23
EABA40000241Piccolo Basic Metabolic Panel400-0024400-00242016-09-23
EABA40000311Piccolo Basic Metabolic Panel Plus400-0031400-00312016-09-23
EABA40000331Piccolo Kidney Check400-0033400-00332016-09-23
EABA40000341Piccolo MetLyte Plus CRP400-0034400-00342016-09-23
EABA40000221Piccolo Electrolyte Panel400-0022400-00222016-09-23
EABA40000251Piccolo Lipid Panel400-0025400-00252016-09-23
EABA40000301Piccolo Lipid Panel Plus400-0030400-00302016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486014037Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-240TECO DIAGNOSTICSCGX2026-04-30
10673486014044Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-480TECO DIAGNOSTICSCGX2026-04-30
MHC1101665142EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
MHC18073002EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
00311917064635WalgreensWALGREEN CO.CGA2025-06-20
00353885013000OneTouch UltraLifeScan U.S. LLCCGA2025-06-20
00194346219254ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00194346219261ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00054749005710i-STAT G CartridgeABBOTT POINT OF CARE INC.CGA2024-04-30
MHC19902833042Members MarkWAL-MART STORES, INC.CGA2023-05-10
MHC19902833062Members MarkWAL-MART STORES, INC.CGA2023-04-18
MHC19902833072Members MarkWAL-MART STORES, INC.CGA2023-04-18
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
00353885012652OneTouch Ultra Blue Test StripsLifeScan U.S. LLCCGA2022-07-28
MHC18490502BluLinkMHC MEDICAL PRODUCTS, LLCCGA2021-05-12
10888277409187MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-11
10888277409170MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-10
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11
10054749005519i-STATABBOTT POINT OF CARE INC.JGS2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CGA2020-05-01
00024291121831On Call Express Blood Glucose Monitoring SystemNAVAJO MANUFACTURING COMPANYCGA2020-03-30
00024291121848On Call Express Blood Glucose Test StripsNAVAJO MANUFACTURING COMPANYCGA2020-03-30
00015482502300Assure® PlatinumARKRAY USA, INC.CGA2019-11-25
10758750031795VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CJY2019-11-13