FDA.reportPublic FDA data

Piccolo Hepatic Function Panel

Primary DI
EABA40000261
Brand
Piccolo Hepatic Function Panel
Company
ABAXIS, INC.
Model
400-0026
Catalog number
400-0026
Device description
The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitroquantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, directbilirubin, total bilirubin, and total protein in heparinized whole blood, heparinized plasma, or serum in a clinical laboratorysetting or point-of-care location.
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
CEKBiuret (Colorimetric), Total Protein
CIGDiazo Colorimetry, Bilirubin
CITNadh Oxidation/Nad Reduction, Ast/Sgot
CJWBromcresol Purple Dye-Binding, Albumin
CKANadh Oxidation/Nad Reduction, Alt/Sgpt
CKFPhenylphosphate, Alkaline Phosphatase Or Isoenzymes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEKBiuret (Colorimetric), Total ProteinClinical Chemistry2
CIGDiazo Colorimetry, BilirubinClinical Chemistry2
CITNadh Oxidation/Nad Reduction, Ast/SgotClinical Chemistry2
CJWBromcresol Purple Dye-Binding, AlbuminClinical Chemistry2
CKANadh Oxidation/Nad Reduction, Alt/SgptClinical Chemistry1
CKFPhenylphosphate, Alkaline Phosphatase Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934592000
K942782000
K950164000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EABA40000261PrimaryHIBCC0
EABA40000260Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Total alkaline phosphatase (ALP) 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 total alkaline phosphatase (ALP) 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
+49 6155780210abaxis@abaxis.de

Regulatory Flags#

DUNS number
555503770
Device count
10
Lot or batch
true
Serial number
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EABA40000031Piccolo Liver Panel Plus400-0003400-00032016-09-23
EABA40000271Piccolo Renal Function Panel400-0027400-00272016-09-23
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
00630414654003Atellica CH AlbPSiemens Healthcare Diagnostics Inc.CJW2026-03-18
00630414654010Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2026-03-18
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
07613336235508Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-02-04
07613336235515Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-01-31
07613336235522Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-01-31
00630414614755Atellica CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414614922Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414313429Atellica CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414313436Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00380740155285AlinityABBOTT IRELANDCJW2024-08-15
00380740155292AlinityABBOTT IRELANDCJW2024-08-15
00380740155483ARCHITECTABBOTT IRELANDCJW2024-08-15
00380740155490ARCHITECTABBOTT IRELANDCJW2024-08-15
00380740167561ARCHITECTABBOTT IRELANDCIG2024-08-15
00380740167578ARCHITECTABBOTT IRELANDCIG2024-08-15
00380740167585AlinityABBOTT IRELANDCIG2024-08-15
07613336130513Alanine Aminotransferase acc. to IFCC IIRoche Diagnostics GmbHCKA2024-01-26
00850053916144IDG/SanzayIDG/SANZAY CorporationCEK2024-01-12
07613336130537Aspartate Aminotransferase acc. to IFCC IIRoche Diagnostics GmbHCIT2024-01-12
00850053916045IDG/SanzayIDG/SANZAY CorporationCIG2024-01-08
00850053916038IDG/SanzayIDG/SANZAY CorporationCIT2024-01-05
00850053916021IDG/SANZAYIDG/SANZAY CorporationCKA2024-01-03
00630414611082Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2023-12-13
00630414306025Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2023-12-13
10673486002171Teco Diagnostics CSF/Urine Protein Reagent SetTECO DIAGNOSTICSCEK2023-11-14
10673486002201Teco Diagnostics Total Protein Reagent SetTECO DIAGNOSTICSCEK2023-11-14