GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
Device Facts
| Record ID | K060205 |
|---|---|
| Device Name | GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER |
| Applicant | Horiba Abx |
| Product Code | CJE · Clinical Chemistry |
| Decision Date | Jul 21, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1050 |
| Device Class | Class 2 |
Indications for Use
General Chemistries reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes. ABX PENTRA ALP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. ABX PENTRA Calcium CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of calcium in human serum and plasma based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). ABX PENTRA CO₂ RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of carbon dioxide in human serum and plasma based on an enzymatic test using phosphoenolpyruvate (PEP), phosphorenolpyruvate carboxylase (PEPC) and an analog of NADH. Bicarbonate/carbon measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. ABX PENTRA Creatinine CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of creatinine in human serum and plasma based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. ABX PENTRA Iron CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of iron (non-heme) in human serum and plasma based on a photometric test (Ferene method). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and hemochromatosis. ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of phosphorus in human serum and plasma based on a UV method using phosphomolybdate. Measurement of phosphorus (inorganic) is used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. ABX PENTRA Urea CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum and plasma based on an enzymatic UV test using urease and glutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of uric acid in human serum and plasma based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. The ABX PENTRA CO₂ Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CO₂ RTU method on Horiba ABX clinical chemistry analyzers as specified on the vial. The ABX PENTRA CO₂ Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CO₂ RTU method as specified in the enclosed annex.
Device Story
Reagents, controls, and calibrators for use on ABX PENTRA 400, a discrete photometric benchtop clinical chemistry analyzer. Device performs quantitative in-vitro determination of specific analytes in human serum and plasma. Operation involves photometric/enzymatic testing; analyzer processes samples and provides results to clinicians for diagnosis and treatment of various metabolic, renal, and bone-related conditions. Used in clinical laboratory settings by trained personnel.
Clinical Evidence
Bench testing only. Performance validated via precision (repeatability/reproducibility per CLSI EP-5A), linearity (CLSI EP-6A), detection limits, and analytical specificity (interference studies). Method comparison studies performed against predicate devices on Roche MIRA Plus analyzer; regression statistics (r² > 0.95) and matrix comparison (serum vs. plasma) support equivalence.
Technological Characteristics
In vitro diagnostic reagents (bi-reagent cassettes or mono-reagent vials). Methods: kinetic photometric, enzymatic UV, colorimetric (Ferene, Trinder). Analyzers: ABX PENTRA 400. Reagents contain buffers, stabilizers, enzymes (urease, GLDH, uricase, peroxidase), and chromogens. Calibration/Control materials: lyophilized or liquid human serum/aqueous matrices. Standards: CLSI EP05-A2, EP06-A, EP09-A2, EP21-A.
Indications for Use
Indicated for quantitative in vitro diagnostic determination of analytes (ALP, Calcium, CO2, Creatinine, Iron, Magnesium, Phosphorus, Urea, Uric Acid) in human serum and plasma for diagnosis and treatment of associated metabolic, renal, bone, and liver diseases. Prescription use only.
Regulatory Classification
Identification
An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Predicate Devices
- Alkaline Phosphatase (Roche) (k801242)
- Calcium (Roche) (k883453)
- CO2 Reagent (Roche) (k031879)
- Creatinine (Roche) (k941837)
- Iron (Raichem) (K864819)
- Magnesium (Roche) (k901758)
- Inorganic Phosphorus (Roche) (k891475)
- BUN (Roche) (k954000)
- Uric Acid (Roche) (K922762)
- CO2 reagent standard (Roche) (k031879)
- Lyphocheck assayed chemistry control Level 1 & Level 2 (BioRad) (k891475)
Related Devices
- K070249 — ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H · Horiba Abx · Apr 26, 2007
- K110137 — ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN · HORIBA ABX SAS · Aug 10, 2011
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k060205
B. Purpose for Submission:
Notification of intent to manufacture and market a group of reagents and their associated controls and calibrators for use on the ABX PENTRA 400
C. Measurand:
Alkaline Phosphatase, Creatinine, Calcium, CO₂, Iron, Magnesium, Phosphorus, Urea, Uric Acid
D. Type of Test:
Colorimetric and enzymatic
E. Applicant:
Horiba ABX
F. Proprietary and Established Names:
Trade/Proprietary Name: ABX PENTRA ALP CP
Common or Usual Name: ALP - Alkaline phosphatase
Trade/Proprietary Name: ABX PENTRA Calcium CP
Common or Usual Name: Calcium
Trade/Proprietary Name: ABX PENTRA CO2 RTU
Common or Usual Name: Carbon Dioxide
Trade/Proprietary Name: ABX PENTRA Creatinine CP
Common or Usual Name: Creatinine
Trade/Proprietary Name: ABX PENTRA Iron CP
Common or Usual Name: Iron
Trade/Proprietary Name: ABX PENTRA Magnesium RTU
Common or Usual Name: Magnesium
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Trade/Proprietary Name: ABX PENTRA Phosphorus CP
Common or Usual Name: Phosphorus
Trade/Proprietary Name: ABX PENTRA Urea CP
Common or Usual Name: Urea
Trade/Proprietary Name: ABX PENTRA Uric Acid CP
Common or Usual Name: Uric Acid
Trade/Proprietary Name: ABX PENTRA CO2 Control
Common or Usual Name: CO2 Control
Trade/Proprietary Name: ABX PENTRA CO2 Cal
Common or Usual Name: CO₂ Calibrator
G. Regulatory Information:
1. Regulation section:
21 CFR 862.1050: Alkaline phosphatase Test System
21 CFR 862.1145: Calcium Test System
21 CFR 862.1160: Bicarbonate/carbon dioxide Test System
21 CFR 862.1225: Creatinine Test System
21 CFR 862.1410: Iron (non-heme) Test System
21 CFR 862.1495: Magnesium Test System
21 CFR 862.1580: Phosphorus (inorganic) Test System
21 CFR 862.1770: Urea nitrogen Test System
21 CFR 862.1775: Uric acid Test System
21 CFR 862.1660: Quality control material (assayed and unassayed)
21 CFR 862.1150: Calibrator
2. Classification:
Class II - Alkaline phosphatase, Calcium, CO₂ RTU, Creatinine, Magnesium, Phosphorus, Urea, Calibrators
Class I, reserved - Iron, Uric Acid, Controls
3. Product code:
Alkaline phosphatase- CJE
Calcium - CIC
CO₂ - KHS
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Creatinine - CGX
Iron - JIY
Magnesium - JGJ
Phosphorus - CEO
Urea - CDQ
Uric Acid - KNK
CO₂ Control – JJX
CO₂ Cal - JIT
4. Panel:
75, Chemistry
H. Intended Use:
1. Intended use(s):
See indications for use below
2. Indication(s) for use:
General Chemistries reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.
ABX PENTRA ALP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
ABX PENTRA Calcium CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of calcium in human serum and plasma based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
ABX PENTRA CO₂ RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of carbon dioxide in human serum and plasma based on an enzymatic test using phosphoenolpyruvate (PEP), phosphorenolpyruvate carboxylase (PEPC) and an analog of NADH. Bicarbonate/carbon measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
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ABX PENTRA Creatinine CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of creatinine in human serum and plasma based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
ABX PENTRA Iron CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of iron (non-heme) in human serum and plasma based on a photometric test (Ferene method). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and hemochromatosis.
ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of phosphorus in human serum and plasma based on a UV method using phosphomolybdate. Measurement of phosphorus (inorganic) is used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
ABX PENTRA Urea CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum and plasma based on an enzymatic UV test using urease and glutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of uric acid in human serum and plasma based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
The ABX PENTRA $\mathrm{CO}_{2}$ Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA $\mathrm{CO}_{2}$ RTU method on Horiba ABX clinical
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chemistry analyzers as specified on the vial.
The ABX PENTRA CO₂ Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CO₂ RTU method as specified in the enclosed annex.
3. Special conditions for use statement(s):
For prescription use only
4. Special instrument requirements:
ABX PENTRA 400 Clinical Chemistry Analyzer
I. Device Description:
The ABX PENTRA ALP CP is an in vitro diagnostic assay for the quantitative determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. It is composed of a bi-reagent cassette, with 26 ml and 6.5 ml compartments.
The ABX PENTRA Calcium CP is an in vitro diagnostic assay for the quantitative determination of calcium in human serum and plasma based on a photometric test using orthocresolphtalein complexone. It is composed of a bi-reagent cassette, with 66 ml and 16.5 ml compartments.
The ABX PENTRA Creatinine CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum and plasma based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a bi-reagent cassette, with two 28 ml compartments.
The ABX PENTRA Iron CP is in vitro diagnostic assay for the quantitative determination of iron (non-heme) in human serum and plasma based on a photometric test (Ferene method). It is composed of a bi-reagent cassette containing 69 ml of reagent 1 and 20 ml of reagent 2.
The ABX PENTRA Magnesium RTU is an in vitro assay for the quantitative determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. It is composed of two identical mono-reagent vials of 25 ml.
The ABX PENTRA Phosphorus CP is an in vitro diagnostic assay for the quantitative determination of phosphorus in human serum and plasma based on a UV method using phosphomolybdate. It is composed of a mono-reagent cassette, with 29.5 ml compartment.
The ABX PENTRA Urea CP is an in vitro diagnostic assay for the quantitative determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum and plasma based on an enzymatic UV test using urease and glutamate dehydrogenase. It is composed of a bi-reagent cassette, with 60 ml and 15 ml
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compartments.
The ABX PENTRA Uric Acid CP is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum and plasma based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). It is composed of a bi-reagent cassette, with 60 ml and 15 ml compartments.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are provided in the package labeling, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.
The ABX PENTRA CO₂ RTU is an in vitro diagnostic assay for the quantitative determination of carbon dioxide in human serum and plasma based on an enzymatic test using phosphoenolpyruvate (PEP), phosphorenolpyruvate carboxylase (PEPC) and an analog of NADH. It is composed of two identical mono-reagent vials of 20 ml.
The ABX PENTRA CO₂ Cal is a liquid calibrator containing chemical components to be used for the calibration of the CO2 assay. The assigned value is given on the calibrator vial. This calibrator is provided in three vials of 3 ml.
The ABX PENTRA CO₂ Control is a liquid assayed control containing chemical components to be used for the quality control of the CO₂ assay. The assigned value is given in the package labeling. This control is provided in three vials of 3 ml.
J. Substantial Equivalence Information:
1. Predicate device name(s):
| New Device | Predicate |
| --- | --- |
| ABX PENTRA ALP CP | Alkaline Phosphatase (Roche) |
| ABX PENTRA Calcium CP | Calcium (Roche) |
| ABX PENTRA CO₂ RTU | CO₂ Reagent (Roche) |
| ABX PENTRA Creatinine CP | Creatinine (Roche) |
| ABX PENTRA Iron CP | Raichem |
| ABX PENTRA Magnesium RTU | Reagent for Magnesium (Roche) |
| ABX PENTRA Phosphorus CP | Inorganic Phosphorus (Roche) |
| ABX PENTRA Urea CP | BUN (Roche) |
| ABX PENTRA Uric Acid CP | Uric Acid Reagent (Roche) |
| ABX PENTRA CO₂ Cal | CO₂ reagent standard (Roche) |
| ABX PENTRA CO₂ Control | Lyphocheck assayed chemistry control Level 1 & Level 2 (BioRad) |
2. Predicate 510(k) number(s):
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| Predicate Device | 510k Number |
| --- | --- |
| Alkaline Phosphatase (Roche) | k801242 |
| Calcium (Roche) | k883453 |
| CO2 Reagent (Roche) | k031879 |
| Creatinine (Roche) | k941837 |
| Iron (Raichem) | K864819 |
| Magnesium (Roche) | k901758 |
| Inorganic Phosphorus (Roche) | k891475 |
| BUN (Roche) | k 954000 |
| Uric Acid (Roche) | K922762 |
| CO2 reagent standard (Roche) | k 031879 |
| Lyphocheck assayed chemistry control Level 1 & Level 2 (BioRad) | k 891475 |
3. Comparison with predicate:
ABX PENTRA ALP CP:
| | Predicate device (K801242): | Device : |
| --- | --- | --- |
| Device Name | Alkaline Phosphatase | ABX Pentra ALP CP |
| Analytes | Alkaline phosphatase | Alkaline phosphatase |
| Method : | Kinetic photometric test using nitrophenylphosphate | Identical |
| Specimen : | Serum
Plasma | Serum
Plasma |
| Component reagent matrices | Single-reagent bottles, lyophilized:
REAGENT : 2-Amino-2-methyl-1,3-propanediol (AMPD), magnesium salt, zinc sulphate, N-(2-Hydroxyethyl)ethylenediaminetriacetic acid (HEDTA), 4-Nitrophenylphosphate, buffers, stabilizers and fillers | Bi-reagent cassette, ready to use:
REAGENT 1 : 2-Amino-2-methyl-1-propanol, magnesium sulphate, zinc sulphate, sodium azide
REAGENT 2 : p-Nitrophenylphosphate, sodium azide |
ABX Pentra Calcium CP:
| | Predicate device (K883453): | Device : |
| --- | --- | --- |
| Device Name | Calcium | ABX Pentra Calcium CP |
| Analytes | Calcium | Calcium |
| Method : | Photometric test using Asenazo III | Photometric test using ortho-cresolphtalein complexone (OPC) |
| Specimen : | Serum | Serum
Plasma |
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| | Predicate device (K883453): | Device : |
| --- | --- | --- |
| Device Name | Calcium | ABX Pentra Calcium CP |
| Component reagent matrices | Single reagent bottles: REAGENT : Arsenazo III, buffers, stabilizers, fillers | Bi-reagent cassette, ready to use REAGENT 1 : Ethanolamine, Detergents REAGENT 2 : o-Cresolphtalein complexone, 8-Hydroxyquinoline, Hydrochloric acid |
| Packaging | Kit composed of single-reagent bottles REAGENT : 2 x 120 ml | Bi-reagent cassette : REAGENT 1 : 66 ml REAGENT 2 : 16.5 ml |
ABX Pentra CO₂ RTU:
| | Predicate device (K031879): | Device : |
| --- | --- | --- |
| Device Name | CO₂ Reagent | ABX Pentra CO₂ RTU |
| Analytes | Carbon dioxide | Carbon dioxide |
| Method : | Enzymatic test using phosphoenolpyruvate (PEP), phosphoenolpyruvate carboxylase (PEPC) and NADH as cofactor | Enzymatic test using phosphoenolpyruvate (PEP), phosphoenolpyruvate carboxylase (PEPC) and an analog of NADH as cofactor |
| Specimen : | Serum
Plasma | Serum
Plasma |
| Component reagent matrices | Single reagent bottle, lyophilized: CO₂ REAGENT : PEP, NAD (reduced), MDH, PEPC, buffers, stabilizers and fillers | Single reagent bottle, ready to use REAGENT : Buffer, PEP, PEPC, MDH, NADH analog, activators, stabilizers, surfactant, preservative |
ABX Pentra Creatinine CP:
| | Predicate device (K941837): | Device : |
| --- | --- | --- |
| Device Name | Creatinine | ABX Pentra Creatinine CP |
| Analytes | Creatinine | Creatinine |
| Method : | Kinetic method using alkaline picrate (modification of the Jaffé reaction) | Kinetic method using alkaline picrate (modification of the Jaffé reaction) |
| Specimen : | Serum
Plasma
Urine | Serum
Plasma |
| Component reagent matrices | Kit composed of: REAGENT 1 : Sodium | Bi-reagent cassette, ready to use |
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ABX Pentra Iron CP:
| Device Name | Predicate device (K941837): | Device : |
| --- | --- | --- |
| Device Name | Creatinine | ABX Pentra Creatinine CP |
| Analytes | borate, stabilizers
REAGENT 2 : Picric acid, Sodium borate, stabilizers | REAGENT 1 : Picric acid
REAGENT 2 : Sodium hydroxide, Disodium phosphate |
| Device Name | Predicate device (K864819): | Device : |
| --- | --- | --- |
| Device Name | Iron | ABX Pentra Iron CP |
| Analytes | Iron | Iron |
| Method : | Colorimetric measurement of iron is performed by releasing the protein bound iron from its carrier protein transferrin and complexing the released iron with a suitable chromogen. In this method the sample is added to an acidic buffered reagent containing hydroxylamine, thiourea and ferene® | Same |
| Specimen : | Serum
Plasma | Serum
Plasma |
| Component reagent matrices | acidic buffered reagent containing hydroxylamine, thiourea and ferene® | acidic buffered reagent containing hydroxylamine, thiourea and ferene® |
ABX Pentra Magnesium RTU:
| Device Name | Predicate device (K901758): | Device : |
| --- | --- | --- |
| Device Name | Reagent for Magnesium | ABX Pentra Magnesium RTU |
| Analytes | Magnesium | Magnesium |
| Method : | Photometric test using Chlorophosphonazo III | Photometric test using xylidyl blue |
| Specimen : | Serum | Serum
Plasma |
| Component reagent matrices | Kit composed of:
REAGENT 1 :
Chlorophosphonazo III, N-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid, Ethylenebis(oxyethyleninitrilo)tetra acetic acid (EGTA), surfactant, preservatives | Single-reagent bottle, ready to use
REAGENT : Ethanolamine, GEDTA, Xylidyl blue, detergents |
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| | Predicate device (K901758): | Device : |
| --- | --- | --- |
| Device Name | Reagent for Magnesium | ABX Pentra Magnesium RTU |
| | REAGENT 2 : Ethylenedaminetetraacetic acid, N-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid, surfactant, preservatives | |
ABX Pentra Phosphorus CP:
| | Predicate device (K883962): | Device : |
| --- | --- | --- |
| Device Name | Inorganic Phosphorus | ABX Pentra Phosphorus CP |
| Analytes | Phosphorus | Phosphorus |
| Method : | UV method using phosphomolybdate | Identical method : UV method using phosphomolybdate |
| Specimen : | Serum
Urine | Serum
Plasma |
| Component reagent matrices | Single reagent bottles, ready to use
REAGENT : Ammonium molybdate, surfactants, buffers, stabilizers, fillers | Mono-reagent cassette, ready to use
REAGENT : Sulfuric acid, Ammonium molybdate |
ABX Pentra Urea CP:
| | Predicate device (K954000): | Device : |
| --- | --- | --- |
| Device Name | BUN | ABX Pentra Urea CP |
| Analytes | Blood Urea Nitrogen (BUN) | Urea / Blood Urea Nitrogen (BUN) |
| Method : | Enzymatic UV test : “Urease – Glutamate Dehydrogenase” | Identical (Enzymatic UV test : “Urease – Glutamate Dehydrogenase”) |
| Specimen : | Serum
Plasma | Serum
Plasma |
| Component reagent matrices | Single-reagent bottle, ready to use:
REAGENT : Alpha-ketoglutarate, Urease, GLDH, Adenosine diphosphate, NADH, Sodium azide, buffer, preservative, stabilizers | Bi-reagent cassette, ready to use
REAGENT 1 : TRIS, 2-Oxoglutarate, ADP, Urease, GLDH (Glutamate dehydrogenase), Sodium azide
REAGENT 2 : NADH, Sodium azide |
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ABX Pentra Uric Acid CP:
| | Predicate device (K922762): | Device : |
| --- | --- | --- |
| Device Name | Uric Acid | ABX Pentra Uric Acid CP |
| Analytes | Uric Acid | Uric Acid |
| Method : | A modification of the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method) | A modification of the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method) |
| Specimen : | Serum
Plasma | Serum
Plasma |
| Component reagent matrices | Two reagent bottles R1 and R2 containing Buffers and uricase (R1) and Peroxidase with stabilizing buffers (R2) | It is composed of a bi-reagent cassette, with 60 ml and 15 ml compartments containing Buffers and uricase (R1) and Peroxidase with stabilizing buffers (R2) |
ABX Pentra CO₂ Cal:
| | Predicate device (K031879): | Device : |
| --- | --- | --- |
| Device Name | CO₂ Standard
(included in the CO2 Reagent kit from Roche) | ABX Pentra CO₂ Cal |
| Method : | Calibration of Roche bicarbonate/CO2 measurement method | Calibration of HORIBA ABX bicarbonate/CO2 measurement method |
| Component matrices | Vial (liquid)
Solution containing 30 mmol/l bicarbonate | Vial (liquid)
Solution containing 30 mmol/l bicarbonate |
ABX Pentra CO₂ Control:
| | Predicate device (K891475): | Device : |
| --- | --- | --- |
| Device Name | Lyphocheck Assayed Chemistry Control Levels 1 and 2 | ABX Pentra CO₂ Control |
| Manufactured by | Bio-Rad Laboratories | HORIBA ABX, France |
| Instrument | - | ABX PENTRA 400 |
| Method : | Multi-parameter control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet | Single-parameter control by monitoring the performances of Bicarbonate/Total CO2 determination with ABX Pentra CO₂ RTU reagent |
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| | Predicate device (K891475): | Device : |
| --- | --- | --- |
| Device Name | Lyphocheck Assayed Chemistry Control Levels 1 and 2 | ABX Pentra CO2 Control |
| Component reagent matrices | Vial (lyophilized) Human serum based with added constituents of purified biochemicals, pure chemicals, therapeutic drugs, preservatives and stabilizers | Vial (liquid) Aqueous matrix with added CO2 |
| Controlled molecules | The exact control values are given in the notice - Multiple parameters, including CO2 | The exact control values are given in the enclosed annex - CO2 |
| Performance data : Theoretical values and confidence intervals | - The mean values are derived from replicate analyses and are lot specific. The tests listed were performed by the reagent manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of control. | - The assigned values are traceable with a reference material in accordance with established protocols. - The assigned values and precise confidence interval are indicated in the annex enclosed in the kit |
# K. Standard/Guidance Document Referenced (if applicable):
- Guidance for Industry and FDA Staff: "Format for Traditional & Abbreviated 510(k)s": August 12, 2005
- "In vitro diagnostics devices : Guidance for the preparation of 510(k) submissions" Jan 1997
- "Guidance for Industry - In vitro diagnostics Bicarbonate/Carbon Dioxide Test System" July 1998
- "Guidance for Industry - In vitro diagnostics Urea Nitrogen Test System" July 1998
- "Guidance for Industry - In vitro diagnostics Creatinine Test System" July 1998
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- “Guidance for Industry and FDA Staff Bundling Multiple Devices or Multiple Indications in a Single Submission” November 2003
- CLSI (NCCLS):
- i) EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition
- ii) EP06-A - Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
- iii) EP09-A2 – Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline -Second Edition
- iv) EP21-A - Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline
L. Test Principle:
The ABX PENTRA ALP CP is a kinetic photometric test using p-Nitrophenylphosphate.
The ABX PENTRA Calcium CP is a photometric test using orthocresolphtalein complexone.
The ABX PENTRA CO₂ RTU is enzymatic test using phosphoenolpyruvate (PEP), phosphorenolpyruvate carboxylase (PEPC) and an analog of NADH.
The ABX PENTRA Creatinine CP is a kinetic method using alkaline picrate (Jaffé method).
The ABX PENTRA Iron CP is a photometric test based upon the Ferene method.
The ABX PENTRA Magnesium RTU is a photometric test using xylidyl blue.
The ABX PENTRA Phosphorus CP is UV method using phosphomolybdate.
The ABX PENTRA Urea CP is an enzymatic UV test using urease and glutamate dehydrogenase.
The ABX PENTRA Uric Acid CP is an enzymatic test of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method)
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
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# ABX PENTRA ALP CP
Repeatability (Within run precision) - 2 controls and 3 specimens of low, medium and high concentrations were tested 20 times in a single run for each sample.
| | Mean Value (U/L) | %CV |
| --- | --- | --- |
| Normal Control | 90.79 | 1.27 |
| Abnormal Control | 252.68 | 0.62 |
| Specimen 1 | 28.05 | 3.98 |
| Specimen 2 | 54.88 | 2.42 |
| Specimen 3 | 430.87 | 0.84 |
Reproducibility (Total precision) - Based upon CLSI EP-5A, two specimens of low & high levels and 2 controls were tested in duplicate for 20 days, two runs per day.
| | Mean Value (U/L) | %CV |
| --- | --- | --- |
| Normal Control | 90.79 | 3.62 |
| Abnormal Control | 254.38 | 2.39 |
| Specimen 1 | 64.11 | 4.36 |
| Specimen 2 | 190.44 | 2.66 |
# ABX PENTRA Calcium CP
Repeatability (Within run precision) - 2 controls and 3 specimens of low, medium and high concentrations were tested 20 times in a single run for each sample.
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 9.4 | 0.92 |
| Abnormal Control | 15.22 | 0.42 |
| Specimen 1 | 6.56 | 0.81 |
| Specimen 2 | 9.32 | 0.51 |
| Specimen 3 | 16.36 | 0.51 |
Reproducibility (Total precision) - Based upon CLSI EP-5A, two specimens of low & high levels and 2 controls were tested in duplicate for 20 days, two runs per day.
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 9.34 | 1.58 |
| Abnormal Control | 15.20 | 1.57 |
| Specimen 1 | 7.04 | 1.49 |
| Specimen 2 | 15.83 | 1.67 |
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# ABX PENTRA CO2 RTU
Repeatability (Within run precision) - 1 control and 3 specimens of low, medium and high concentrations were tested 20 times in a single run for each sample.
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Control | 20.44 | 1.25 |
| Specimen 1 | 10.93 | 0.78 |
| Specimen 2 | 21.30 | 0.51 |
| Specimen 3 | 32.03 | 0.66 |
Reproducibility (Total precision) - Based upon CLSI EP-5A, two specimens of low & high levels and 1 control were tested in duplicate for 20 days, two runs per day.
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Control | 20.75 | 4.77 |
| Specimen 1 | 9.53 | 7.70 |
| Specimen 2 | 31.57 | 5.93 |
# ABX PENTRA Creatinine CP
Repeatability (Within run precision) - 2 controls and 3 specimens of low, medium and high concentrations were tested 20 times in a single run for each sample.
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 1.28 | 1.58 |
| Abnormal Control | 3.38 | 0.66 |
| Specimen 1 | 0.59 | 2.09 |
| Specimen 2 | 1.55 | 0.71 |
| Specimen 3 | 7.64 | 0.39 |
Reproducibility (Total precision) - Based upon CLSI EP-5A, two specimens of low & high levels and 2 controls were tested in duplicate for 20 days, two runs per day.
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 1.27 | 3.47 |
| Abnormal Control | 3.45 | 2.56 |
| Specimen 1 | 1.29 | 3.69 |
| Specimen 2 | 6.75 | 2.04 |
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# ABX PENTRA Iron CP
Repeatability (Within run precision) - 2 controls and 3 specimens of low, medium and high concentrations were tested 20 times in a single run for each sample.
| | Mean Value (ug/dL) | %CV |
| --- | --- | --- |
| Normal Control | 115.36 | 1.89 |
| Abnormal Control | 189.92 | 1.5 |
| Specimen 1 | 50.41 | 2.56 |
| Specimen 2 | 95.91 | 2.32 |
| Specimen 3 | 680.26 | 0.32 |
Reproducibility (Total precision) - Based upon CLSI EP-5A, two specimens of low & high levels and 2 controls were tested in duplicate for 20 days, two runs per day.
| | Mean Value (ug/dL) | %CV |
| --- | --- | --- |
| Normal Control | 116.83 | 2.98 |
| Abnormal Control | 191.05 | 2.61 |
| Specimen 1 | 74.4 | 3.61 |
| Specimen 2 | 510.99 | 1.78 |
# ABX PENTRA Magnesium RTU
Repeatability (Within run precision) - 2 controls and 3 specimens of low, medium and high concentrations were tested 20 times in a single run for each sample.
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 2.44 | 2.02 |
| Abnormal Control | 4.19 | 1.28 |
| Specimen 1 | 1.58 | 2.28 |
| Specimen 2 | 2.27 | 1.92 |
| Specimen 3 | 2.86 | 1.98 |
Reproducibility (Total precision) - Based upon CLSI EP-5A, two specimens of low & high levels and 2 controls were tested in duplicate for 20 days, two runs per day.
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 2.50 | 3.19 |
| Abnormal Control | 4.27 | 2.80 |
| Specimen 1 | 2.20 | 2.63 |
| Specimen 2 | 3.19 | 2.79 |
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# ABX PENTRA Phosphorus CP
Repeatability (Within run precision) - 2 controls and 3 specimens of low, medium and high concentrations were tested 20 times in a single run for each sample.
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 4.08 | 1.26 |
| Abnormal Control | 6.34 | 0.77 |
| Specimen 1 | 2.39 | 2.48 |
| Specimen 2 | 3.48 | 1.61 |
| Specimen 3 | 9.19 | 1.38 |
Reproducibility (Total precision) - Based upon CLSI EP-5A, two specimens of low & high levels and 2 controls were tested in duplicate for 20 days, two runs per day.
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 4.01 | 2.50 |
| Abnormal Control | 6.35 | 1.82 |
| Specimen 1 | 2.50 | 3.56 |
| Specimen 2 | 11.44 | 1.38 |
# ABX PENTRA Urea CP
Repeatability (Within run precision) - 2 controls and 3 specimens of low, medium and high concentrations were tested 20 times in a single run for each sample.
Urea Nitrogen:
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 40.1 | 2.27 |
| Abnormal Control | 155.6 | 1.66 |
| Specimen 1 | 12.9 | 2.76 |
| Specimen 2 | 44.6 | 1.58 |
| Specimen 3 | 182.7 | 1.80 |
Blood Urea Nitrogen:
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 18.73 | 2.27 |
| Abnormal Control | 72.78 | 1.66 |
| Specimen 1 | 6.02 | 2.76 |
| Specimen 2 | 20.86 | 1.58 |
| Specimen 3 | 85.46 | 1.80 |
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Reproducibility (Total precision) - Based upon CLSI EP-5A, two specimens of low & high levels and 2 controls were tested in duplicate for 20 days, two runs per day.
Urea Nitrogen:
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 39.4 | 2.14 |
| Abnormal Control | 153.2 | 1.93 |
| Specimen 1 | 149.9 | 2.14 |
| Specimen 2 | 70.12 | 1.97 |
Blood Urea Nitrogen:
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 18.45 | 2.14 |
| Abnormal Control | 71.69 | 1.93 |
| Specimen 1 | 19.24 | 2.14 |
| Specimen 2 | 70.12 | 1.97 |
## ABX PENTRA Uric Acid CP
Repeatability (Within run precision) - 2 controls and 3 specimens of low, medium and high concentrations were tested 20 times in a single run for each sample.
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 4.62 | 0.45 |
| Abnormal Control | 11.63 | 0.34 |
| Specimen 1 | 2.53 | 1.24 |
| Specimen 2 | 4.58 | 0.91 |
| Normal Control | 7.19 | 1.02 |
Reproducibility (Total precision) - Based upon CLSI EP-5A, two specimens of low & high levels and 2 controls were tested in duplicate for 20 days, two runs per day.
| | Mean Value (Mg/dL) | %CV |
| --- | --- | --- |
| Normal Control | 4.64 | 2.81 |
| Abnormal Control | 11.73 | 1.39 |
| Specimen 1 | 4.67 | 2.64 |
| Specimen 2 | 6.74 | 2.51 |
## b. Linearity/assay reportable range:
Linearity studies across the measuring range of the assay were performed via protocols based upon CLSI EP6-A. The studies demonstrated linearity of the
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assays and the linear regression statistics listed below. In addition, post dilution studies were performed to validate the automated dilution function and range.
## ABX PENTRA ALP CP
The measuring range of the assay is 6 – 1500 U/L; Post dilution up to 6000 U/L.
Linear regression statistics: $y = 0.9461x + 15.89$ ; $R^2 = 0.9993$
## ABX PENTRA Calcium CP
The measuring range of the assay is $0.16 - 20\mathrm{mg / dL}$ ; Post dilution up to 40 mg/dL.
Linear regression statistics: $y = 1.0451x - 0.1221$ ; $R^2 = 0.9994$
## ABX PENTRA CO2 RTU
The measuring range of the assay is $1.8 - 60.8 \, \text{mmol/L}$ ; Post dilution up to 121 mmol/L.
Linear regression statistics: $y = 1.0201x - 0.2967$ ; $R^2 = 0.9999$
## ABX PENTRA Creatinine CP
The measuring range of the assay is $0.11 - 15.8\mathrm{mg / dL}$ ; Post dilution up to 79 mg/dL.
Linear regression statistics: $y = 0.9448x + 20.05$ ; $R^2 = 0.9997$
## ABX PENTRA Iron CP
The measuring range of the assay is $7.42 - 1004\mu \mathrm{g / dL}$ ; Post dilution up to 5020 $\mu \mathrm{g / dL}$ .
Linear regression statistics: $y = 1.0065x - 0.3502$ ; $R^2 > 0.9999$
## ABX PENTRA Magnesium RTU
The measuring range of the assay is $0.17 - 4.64\mathrm{mg / dL}$ ; Post dilution up to 13.92 mg/dL.
Linear regression statistics: $y = 0.9277x + 0.0515$ ; $R^2 = 0.998$
## ABX PENTRA Phosphorus CP
The measuring range of the assay is $0.28 - 24.18\mathrm{mg / dL}$ ; Post dilution up to 96.72 mg/dL.
Linear regression statistics: $y = 1.0146x - 0.043$ ; $R^2 = 0.9998$
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# ABX PENTRA Urea CP
The measuring range of the assay is 0.9 - 300 mg/dL (0.9 - 140.3 mg/dL for BUN); Post dilution up to 1500 mg/dL (up to 701.5 for BUN).
Linear regression statistics: y = 0.9878x + 0.1583; R² = 0.9998
# ABX PENTRA Uric Acid CP
The measuring range of the assay is 0.19 - 25 mg/dL; Post dilution up to 75 mg/dL.
Linear regression statistics: y = 1.0173x - 1.2204; R² > .9999
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Protocols and acceptance criteria for on-board and shelf life stability studies were described and found to be acceptable.
# ABX Pentra CO₂ Control traceability
The ABX Pentra CO₂ Control is gravimetrically prepared to a concentration of 20 mmol/l sodium bicarbonate. The value of the ABX Pentra CO₂ Control is assigned using a biochemistry analyzer, e.g. Hitachi 911.
# ABX Pentra CO₂ Calibrator traceability
ABX Pentra CO₂ Cal is made from a secondary reference material, traceable to NIST 723c to a concentration of 30 mmol/l sodium bicarbonate. The Master Lot is stored under the same conditions as a normal production lot, and has the same expiration date: 15 months after production at 2-8°C. The target value is determined by the median of all results yielded from the 6 devices (150 measurements/parameter).
d. Detection limit:
Method: Based upon the Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986, (44), 686-745)
Minimum Detection Limit (MDL) was calculated from 30 measurements of saline water (0.9 g/l)
Formula: MDL = mean of measurements + 4.65 SD (mean of measurement = 0 when negative)
Using the above criteria, the following minimum detection limits were determined:
ABX PENTRA ALP CP - 6 U/L
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ABX PENTRA Calcium CP - 0.16 Mg/dL
ABX PENTRA CO2 RTU - 1.8 mmol/L
ABX PENTRA Creatinine CP - 0.11 Mg/dL
ABX PENTRA Iron CP - 7.42 ug/dL
ABX PENTRA Magnesium RTU - 0.17 Mg/dL
ABX PENTRA Phosphorus CP - 0.28 Mg/dL
ABX PENTRA Urea CP - 0.9 Mg/dL
ABX PENTRA Uric Acid CP - 0.19 Mg/dL
e. Analytical specificity:
Substances were added to pooled Human serum samples at two different measurand concentrations (normal and high). The base serum with each interfering substance was then serially diluted with the same base serum containing saline instead of interfering substance to adjust for analyte concentration.
Method: Based upon the Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986, (44), 686-745)
ABX PENTRA ALP CP - Hemoglobin up to 195 μmol/l (3.36 g/l or 336 mg/dl), total bilirubin up to 470 μmol/l (27.5 mg/dl), direct bilirubin up to 250 μmol/l (14.6 mg/dl) and triglycerides (as Intralipid ®, representative of lipemia) up to 7 mmol/l (612.5 mg/dl) do not interfere with ALP determination by this test.
ABX PENTRA Calcium CP - Hemoglobin up to 195 μmol/l (3.36 g/l or 336 mg/dl), Total Bilirubin up to 101 μmol/l (5.91 mg/dl), direct bilirubin up to 1357 μmol/l (79.4 mg/dl) and triglycerides (as Intralipid ®, representative of lipemia) up to 7 mmol/l (612.5 mg/dl) do not interfere with calcium determination by this test.
ABX PENTRA CO2 RTU - Hemoglobin up to 195 μmol/l (336 mg/dl), total bilirubin up to 250 μmol/l (14.6 mg/dl), direct bilirubin up to 370 μmol/l (21.6 mg/dl) and triglycerides (as Intralipid ®, representative of lipemia) up to 7 mmol/l (612.5 mg/dl) do not interfere with bicarbonates determination by this test.
ABX PENTRA Creatinine CP - Hemoglobin up to 319 μmol/l (550 mg/dl), total bilirubin up to 176 μmol/l (10.30 mg/dl), direct bilirubin up to 92 μmol/l (5.38 mg/dl), triglycerides (as Intralipid ®, representative of lipemia) up to 7
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mmol/l (612.5 mg/dl) and glucose up to 22.5 mmol/l (405 mg/dl) do not interfere with creatinine determination by this test.
ABX PENTRA Iron CP - Hemoglobin up to 104 μmol/l (180 mg/dl), total bilirubin up to 321 μmol/l (18.78 mg/dl), direct bilirubin up to 289 μmol/l (16.91 mg/dl) and triglycerides (as Intralipid ®, representative of lipemia) up to 7 mmol/l (612.5 mg/dl) do not interfere with Iron determination by this test.
ABX PENTRA Magnesium RTU - Hemoglobin up to 195 μmol/l (336 mg/dl), total bilirubin up to 290 μmol/l (16.97 mg/dl), direct bilirubin up to 520 μmol/l (30.42 mg/dl) and triglycerides (as Intralipid ®, representative of lipemia) up to 7 mmol/l (612.5 mg/dl) do not interfere with Magnesium determination by this test.
ABX PENTRA Phosphorus CP - Hemoglobin up to 72.5 μmol/l (1.25 g/l or 125 mg/dl), total bilirubin up to 102.6 μmol/l (6 mg/dl), direct bilirubin up to 427 μmol/l (25 mg/dl) and triglycerides (as Intralipid ®, representative of lipemia) up to 3 mmol/l (262.5 mg/dl) do not interfere with Phosphorus determination by this test.
ABX PENTRA Urea CP - Hemoglobin up to 267 μmol/l (460 mg/dl), total bilirubin up to 380 μmol/l (22.23 mg/dl), direct bilirubin up to 400 μmol/l (23.40 mg/dl) and triglycerides (as Intralipid ®, representative of lipemia) up to 7 mmol/l (612.5 mg/dl) do not interfere with Urea/BUN determination by this test.
ABX PENTRA Uric Acid CP - Hemoglobin up to 290 μmol/l (500 mg/dl), total bilirubin up to 616 μmol/l (36 mg/dl), direct bilirubin up to 513 μmol (30 mg/dl) and triglycerides (as Intralipid ®, representative of lipemia) up to 7 mmol/l (612.5 mg/dl) do not interfere with uric acid determination by this test.
f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
ABX PENTRA ALP CP
A total of 105 samples were compared with the Roche Alkaline Phosphatase reagent (predicate) on the Roche MIRA Plus.
$$
y = 1.0692x - 5.1259, r^2 = 0.9981
$$
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Additional studies were performed to provide complementary data covering the Alkaline Phosphatase assay range 6 – 1500 U/L. Samples were spiked or diluted depending upon test conditions (high or low range study). Low range study: sample range 7.2 – 35.5 U/L, n=14, y=0.8789x-1.6928, r²=0.9833. High Range study: sample range 1247.8 – 1598 U/L, n=12, y=1.0634x+43.3, r²=0.932.
## ABX PENTRA Calcium CP
A total of 95 samples were compared with the Roche Calcium reagent (predicate) on the Roche MIRA Plus.
$$
y = 1.128x - 0.2145, r^2 = 0.9501
$$
Additional studies were performed to provide complementary data covering the Calcium assay range 0.6 – 20.10 mg/dl. Samples were spiked or diluted depending upon test conditions (high or low range study). Low range study: sample range 0.24 – 11.19 mg/dl, n=15, y=1.0409x + 0.1034, r²=0.9982. High Range study: sample range 16.8 – 22.46 mg/dl, n=15, y=1.2507x – 1.9012, r²=0.9626
## ABX PENTRA CO₂ RTU
A total of 97 samples were compared with the Roche CO₂ reagent on the Roche MIRA Plus.
$$
y = 0.927x - 1.615, r^2 = 0.9763
$$
Additional studies were performed to provide complementary data covering the CO₂ RTU assay range 1.8 – 60.8 mmol/l. Samples were spiked or diluted depending upon test conditions (high or low range study). Low range study: sample range 1.2 – 14.8 mmol/l, n=15, y=0.9986x + 0.2329, r²=0.9936. High Range study: sample range 23.2 – 41.9 mmol/l, n=14, y=1.0784x – 2.7369, r²=0.9217
## ABX PENTRA Creatinine CP
A total of 95 samples were compared with the Roche Creatinine reagent on the Roche MIRA Plus.
$$
y = 1.0109x - 18.735, r^2 = 0.9955
$$
Additional studies were performed to provide complementary data covering the Creatinine assay range 0.11 – 15.8 mg/dl. Samples were spiked or diluted depending upon test conditions (high or low range study). Low range study: sample range 0.08 – 1.02 mg/dl, n=16, y=1.0417x + 0.0779, r²=0.9438. High Range study: sample range 8.82 – 16.35 mg/dl, n=13, y=1.0241x – 0.7807, r²=0.9759
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# ABX PENTRA Iron CP
A total of 98 samples were compared with the Raichem Iron reagent on the Roche MIRA Plus.
$$
y = 1.1307x + 0.88, r^2 = 0.9975
$$
Additional studies were performed to provide complementary data covering the Creatinine assay range $0.11 - 15.8\ \mathrm{mg/dl}$. Samples were spiked or diluted depending upon test conditions (high or low range study). Low range study: sample range $0.08 - 1.02\ \mathrm{mg/dl}$, $n=16$, $y=1.0417x + 0.0779$, $r^2=0.9438$. High Range study: sample range $8.82 - 16.35\ \mathrm{mg/dl}$, $n=13$, $y=1.0241x - 0.7807$, $r^2=0.9759$
# ABX PENTRA Magnesium RTU
A total of 75 samples were compared with the Roche Magnesium reagent on the Roche MIRA Plus.
$$
y = 1.2532x - 0.1018, r^2 = 0.9712
$$
Additional studies were performed to provide complementary data covering the Magnesium assay range $0.17 - 4.64\ \mathrm{mg/dl}$. Samples were spiked or diluted depending upon test conditions (high or low range study). Low range study: sample range $0.19 - 1.38\ \mathrm{mg/dl}$, $n=18$, $y=1.1644x - 0.2428$, $r^2=0.8674$. High Range study: sample range $0.19 - 6.42\ \mathrm{mg/dl}$, $n=93$, $y=1.2707x - 0.3034$, $r^2=0.9849$.
# ABX PENTRA Phosphorus CP
A total of 105 samples were compared with the Roche Phosphorus reagent on the Roche MIRA Plus.
$$
y = 1.035x + 0.0858, r^2 = 0.9967
$$
Additional studies were performed to provide complementary data covering the Phosphorus assay range $0.28 - 24.18\ \mathrm{mg/dl}$. Samples were spiked or diluted depending upon test conditions (high or low range study). Low range study: sample range $0.25 - 2.23\ \mathrm{mg/dl}$, $n=14$, $y=1.1075x - 0.0029$, $r^2=0.9896$. High Range study: sample range $15.16 - 25.05\ \mathrm{mg/dl}$, $n=13$, $y=1.2156x - 2.9012$, $r^2=0.978$
# ABX PENTRA Urea CP
A total of 108 samples were compared with the Roche BUN reagent on the Roche MIRA Plus.
Urea (mmol/L)
$$
y = 1.039x + 0.116, r^2 = 0.9904
$$
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BUN (mg/dL)
y=1.039x+0.697, r² = 0.9905
Additional studies were performed to provide complementary data covering the BUN assay range 0.9 – 140.3 mg/dl. Samples were tested based upon recommendations in NCCLS (CLSI) EP-9A2 guidance. Samples were spiked or diluted depending upon test conditions (high or low range study). Low range study: sample range 0.79 – 5.25 mg/dl, n=15, y=0.8334x + 0.1903, r²=0.9484. High Range study: sample range 95.79 – 138.89 mg/dl, n=13, y=0.8862x + 14.677, r²=0.993.
## ABX PENTRA Uric CP
A total of 98 samples were compared with the Roche Uric Acid reagent on the Roche MIRA Plus.
y=0.0936x+14.14.13, r² = 0.9579
Additional studies were performed to provide complementary data covering the Uric Acid assay range 0.19 – 25 mg/dl. Samples were spiked or diluted depending upon test conditions (high or low range study). Low range study: sample range 0.15 – 2.42 mg/dl, n=15, y=0.899x -0.001, r²=0.9927. High Range study: sample range 7.74 – 23.96 mg/dl, n=19, y=0.942x - 0.122, r²=0.9936.
## b. Matrix comparison:
Method: To demonstrate equivalence of analyte results in serum and Plasma Heparin-Lithium samples, comparison study was performed on samples that were evaluated on Pentra 400 analyzer using ABX Pentra reagents. Comparisons were made serum vs plasma for corresponding samples.
## ABX PENTRA ALP CP
Slope: y = 0.9486x + 0.2488, r² = 0.992, N = 45 on serum versus Lithium-Heparin Plasma
## ABX PENTRA Calcium CP
Slope: y = 0.6903x + 0.7822, r² = 0.649, N = 43 on serum versus Lithium-Heparin Plasma
Because of 3 outliers at the higher end of the range, the sponsor also performed Passing-Bablock analysis:
Variable X : Serum
Variable Y : Plasma
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In mmol/l:
y = 0.9714x + 0.0943
Intercept 95% CI: -0.2190 to 0.4271
Slope 95% CI: 0.8387 to 1.1000
## ABX PENTRA CO₂ RTU
Slope: y = 0.9200x - 0.1700, r² = 0.7569, N=33 on serum versus Lithium-Heparin Plasma
## ABX PENTRA Creatinine CP
Slope: y = 1.0227x-4.1072, N=34 on serum versus Lithium-Heparin Plasma
## ABX PENTRA Iron CP
Slope: y = 0.9885x+0.348, r² = 0.7569, N=40 on serum versus Lithium-Heparin Plasma
## ABX PENTRA Magnesium RTU
Slope: y = 0.971x - 0.0185, r² = 0.9883, N=41 on serum versus Lithium-Heparin Plasma
## ABX PENTRA Phosphorus CP
Slope: y = 0.9858x + 0.0255, r² = 0.9981, N=42 on serum versus Lithium-Heparin Plasma
## ABX PENTRA Urea CP
Urea (mmol/L)
Slope: y = 0.9986x + 0.0211, r² = 0.994, N=43 on serum versus Lithium-Heparin Plasma
BUN (mg/dL)
Slope: y = 0.9986x + 0.0593, r² = 0.994, N=43 on serum versus Lithium-Heparin Plasma
## ABX PENTRA Uric Acid CP
Slope y=1.0224x-2.3035, r² = 0.9952, N=36 on serum versus Lithium-Heparin Plasma
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The results support equivalency of serum specimens and Heparin-Lithium Plasma for the above assays.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
ABX PENTRA ALP CP
Adults (37°C) : (1)
Women 20 - 50 [U/I] 42 - 98
years
Men 20 - 50 years [U/I] 53 - 128
Women > 60 years [U/I] 53 - 141
Men > 60 years [U/I] 56 - 119
Children (37°C) : (2) Female Male
1 - 30 days [U/I] 48 - 406 75 - 319
1 month - 1 year [U/I] 124 - 341 82 - 383
1 - 3 year(s) [U/I] 108 - 317 104 - 345
4 - 6 years [U/I] 96 - 297 93 - 309
7 - 9 years [U/I] 69 - 325 86 - 315
10 - 12 years [U/I] 51 - 332 42 - 362
13 - 15 years [U/I] 50 - 162 74 - 390
16 - 18 years [U/I] 47 - 119 52 - 171
References:
1. Burtis CA, Ashwood ER. Eds. Tietz textbook of clinical chemistry. 3rd ed.
Philadelphia: W. B. Saunders Company, 1999. p. 1829.
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2. Soldin JS, Hicks JM. Pediatric reference ranges. Washington: AACC Press, 1996. p. 5.
## ABX PENTRA Calcium CP
Serum / Plasma: 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l)
Reference:
Endres D.B., Rude R.K. Mineral and bone metabolism. In: Burtis C.A., Ashwood E.R., editors. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B. Saunders Company; 1999. p. 1395-1457.
## ABX PENTRA CO2 RTU
Adults: 22 - 29 mmol/l.
Reference:
Müller-Plathe O. Acid base balance and blood gases. In: Thomas L., editor. Clinical laboratory diagnostics. 1st ed. Frankfurt: T.H. BooksVerlagsgesellschaft; 1998. p.318-329.
## ABX PENTRA Creatinine CP
| Men | | Women | | |
| --- | --- | --- | --- | --- |
| 8 | 13 | 6 | 12 | mg/L |
| 0.8 | 1.3 | 0.6 | 1.2 | mg/dL |
| 71 | 115 | 53 | 106 | μmol/L |
Reference:
Tietz, N.W. Clinical guide to laboratory tests, 3ème Ed, (W.B. Saunders eds. Philadelphia USA), (1995), 186.
## ABX PENTRA Iron CP
| | ug/dl | umol/l |
| --- | --- | --- |
| Children | | |
| 2 weeks | 63-201 | 11-36 |
| 6 months | 28-135 | 5-24 |
| 12 months | 35-155 | 6-28 |
| 2 – 12 years | 22-135 | 4-24 |
{28}
| | ug/dl | umol/l |
| --- | --- | --- |
| Women | | |
| 25 years | 37-165 | 6.6-29.5 |
| 40 years | 23-134 | 4.1-24.0 |
| 60 years | 39-149 | 7.0-26.7 |
| Pregnant Women | | |
| 12thgestational week | 42-177 | 7.6-31.6 |
| At term | 25-137 | 4.5-24.5 |
| 6 weeks postpartum | 16-150 | 2.9-26.9 |
| Men | | |
| 25 years | 40-155 | 7.2-27.7 |
| 40 years | 35-168 | 6.3-30.1 |
| 60 Years | 40-120 | 7.2-21.5 |
Reference: Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 273-5.
# ABX PENTRA Magnesium RTU
Neonates: 1.2 - 2.6 mg/dl (0.48 - 1.05 mmol/l)
Children: 1.5 - 2.3 mg/dl (0.60 - 0.95 mmol/l)
Women: 1.9 - 2.5 mg/dl (0.77 - 1.03 mmol/l)
Men: 1.8 - 2.6 mg/dl (0.73 - 1.06 mmol/l)
References :
- Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 231-241.
- Sitzmann FC. Normalwerte. München: Hans Marseille Verlag GmbH: 1986. p. 166.
# ABX PENTRA Phosphorus CP
Serum/Plasma: 27 - 45 mg/L
2.7-4.5 mg/dL
0.87-1.45 mmol/L
Reference :
Endres, D.B., Rude, R.K., Mineral and bone metabolism. Tietz Fundamentals of Clinical Chemistry, Burtis, C.A. et Ash-wood, E.R. (W.B. Saunders eds. Philadelphia USA), (2001), 795.
{29}
30
ABX PENTRA Urea CP
| In Serum / Plasma | Urea | | BUN
[mg/dl] |
| --- | --- | --- | --- |
| | [mg/dl] | [mmol/l] | |
| Adults: | | | |
| Global | 17-43 | 2.8-7.2 | 7.9-20.2 |
| Women <50 years | 15-40 | 2.6-6.7 | 7.3-18.8 |
| Women >50 years | 21-43 | 3.5-7.2 | 9.8-20.2 |
| Men <50 years | 19-44 | 3.2-7.3 | 9.0-20.5 |
| Men >50 years | 18-55 | 3.0-9.2 | 8.4-25.8 |
| Children: | | | |
| 1-3 years | 11-36 | 1.8-6.0 | 5.1-16.8 |
| 4-13 years | 15-36 | 2.5-6.0 | 7.0-16.8 |
| 14-19 years | 18-45 | 2.9-7.5 | 8.1-21.1 |
Reference:
Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books
Verlagsgesellschaft; 1998. p. 374-377.
ABX PENTRA Uric Acid CP
Serum, plasma:
Women: 26 - 60 mg/L
2.6 - 6 mg/dL
155 - 357 μmol/l
Men: 35 - 72 mg/L
3,5 - 7,2 mg/dL
208 - 428 μmol/L
Reference: Tietz, N.W., Clinical guide to laboratory tests. 3ème Ed., (W.B. Saunders eds. Philadelphia USA), (1995), 268.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
