DEVICE: Piccolo MetLyte 8 Panel (EABA40000231)
Device Identifier (DI) Information
Piccolo MetLyte 8 Panel
400-0023
In Commercial Distribution
400-0023
ABAXIS, INC.
400-0023
In Commercial Distribution
400-0023
ABAXIS, INC.
The Piccolo® MetLyte 8 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 chloride, creatine kinase, creatinine, glucose, 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
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
| 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.
|
Active | false |
| 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.
|
Obsolete | false |
| 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.
|
Active | false |
| 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.
|
Active | false |
| 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.
|
Active | false |
| 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.
|
Active | false |
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride |
| JGS | Electrode, Ion Specific, Sodium |
| KHS | Enzymatic, Carbon-Dioxide |
| CEM | Electrode, Ion Specific, Potassium |
| JLB | Atp And Creatine Kinase (Enzymatic), Creatine |
| CDN | Urease, Photometric, Urea Nitrogen |
| CGX | Alkaline Picrate, Colorimetry, Creatinine |
| CGA | Glucose Oxidase, Glucose |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K010670 | 000 |
| K934592 | 000 |
| K942782 | 000 |
| K992140 | 000 |
| K993211 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit |
| Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
11474676-58e3-4809-ad65-a3f4dabbffc5
December 20, 2022
5
September 23, 2016
December 20, 2022
5
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
EABA40000230
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-822-2947
Piccolo@abaxis.com +496155780210
abaxis@abaxis.de +1 (510) 675 6500
abaxis@abaxis.com
Piccolo@abaxis.com +496155780210
abaxis@abaxis.de +1 (510) 675 6500
abaxis@abaxis.com