ABX PENTRA 400: LIPOPROTEINS
Device Facts
| Record ID | K060854 |
|---|---|
| Device Name | ABX PENTRA 400: LIPOPROTEINS |
| Applicant | Horiba Abx |
| Product Code | JIT · Clinical Chemistry |
| Decision Date | Aug 24, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
Indications for Use
All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of their respective analytes : Cholesterol, HDL-C. LDL-C and Triglycerides using human serum and plasma. The controls, calibrators and additional reagents are intended for use in association with the above reagents.
Device Story
System comprises reagents, calibrators, and controls for use on ABX PENTRA 400 clinical chemistry analyzer; performs quantitative in vitro diagnostic assays for cholesterol, HDL-C, LDL-C, and triglycerides. Input: human serum or plasma samples. Operation: enzymatic photometric/colorimetric assays (Trinder's reaction, accelerator selective detergent methodology, lipase hydrolysis/glycerol kinase). Output: quantitative analyte concentration values. Used in clinical laboratory settings by trained personnel. Healthcare providers use results to diagnose/monitor lipid metabolism disorders, diabetes, and endocrine conditions; aids in clinical decision-making regarding patient lipid management.
Clinical Evidence
Bench testing only. Performance evaluated via precision (CLSI EP05-A2), linearity (CLSI EP06-A), and method comparison (CLSI EP09-A2) against predicate reagents. Precision studies (N=80) showed CVs ranging from 0.53% to 6.39%. Method comparison (N=121-135 samples per analyte) yielded correlation coefficients (r²) between 0.9768 and 0.9994. Accuracy for cholesterol was validated via CRMLN certification.
Technological Characteristics
In vitro diagnostic reagents, lyophilized human serum calibrators/controls, and chemical cleaning solutions. Sensing principle: enzymatic photometric/colorimetric assays. Form factor: reagent cassettes for ABX PENTRA 400 benchtop analyzer. Connectivity: standalone analyzer integration. Sterilization: N/A (chemical reagents).
Indications for Use
Indicated for quantitative in vitro diagnostic determination of cholesterol, HDL-C, LDL-C, and triglycerides in human serum and plasma. Used in the diagnosis and treatment of lipid metabolism disorders, diabetes mellitus, nephrosis, liver obstruction, and endocrine disorders.
Regulatory Classification
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
- Roche Cholesterol Reagent (k941573)
- Ultra N-Geneous HDL Cholesterol Reagent (k021316)
- N-Geneous LDL Cholesterol Reagent (k971573)
- Roche Reagent for Triglycerides (k893973)
- Roche Apolipoprotein Standard (k021316)
- Ultra N-Geneous HDL Cholesterol Reagent Calibrator (k971573)
- N-Geneous LDL Cholesterol Reagent Calibrator (k971573)
- Liquichek Lipids Control (k971573)
Related Devices
- K122757 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT · Alfa Wassermann Diagnostic Technologies, Inc. · Oct 5, 2012
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k060854
B. Purpose for Submission:
New Device
C. Measurand:
Cholesterol
HDL Cholesterol
LDL Cholesterol
Triglycerides
HDL Cholesterol Calibrator
LDL Cholesterol Calibrator
D. Type of Test:
Quantitative immunoturbidimetric and enzymatic photometric assays
E. Applicant:
HORIBA ABX
F. Proprietary and Established Names:
ABX PENTRA 400: Lipoproteins
G. Regulatory Information:
1. Regulation section:
21CFR Sec. 862.1150 - Calibrator.
21CFR Sec. 862.1660 - Quality control material (assayed and unassayed).
21CFR Sec. 862.1705 - Triglyceride test system.
21CFR Sec. 862.1175 - Cholesterol (total) test system.
21CFR Sec. 862.1475 - Lipoprotein test system.
2. Classification:
Class II, Class I reserved, and Class I meets the limitations to exemptions 21 CFR §862.9 (c) (4)
3. Product code:
JIT - Calibrator, Secondary
JJY - Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
CDT - Lipase Hydrolysis/Glycerol Kinase Enzyme
CHH - Enzymatic Esterase--Oxidase, Cholesterol
LBR - LDL & VLDL Precipitation, HDL
MRR - Low Density Lipoprotein
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4. Panel: Chemistry (75)
H. Intended Use:
1. Intended use(s): See indications for use below.
2. Indication(s) for use:
ABX PENTRA Cholesterol CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction).
ABX PENTRA HDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of High Density Lipoprotein Cholesterol (HDL-C) in human serum and plasma based on an enzymatic assay with accelerator selective detergent methodology.
ABX PENTRA LDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and plasma based on an enzymatic colorimetric assay.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
ABX PENTRA Triglycerides CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of triglycerides in human serum and plasma based on an enzymatic colorimetric assay.
Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
The ABX PENTRA HDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HDL Direct CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA LDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA LDL Direct CP method on Horiba ABX clinical chemistry analyzers.
3. Special conditions for use statement(s): Prescription Use
4. Special instrument requirements: ABX PENTRA 400 (k052007)
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I. Device Description:
ABX Pentra Cholesterol CP is ready-to-use.
Reagent
Good’s buffer pH 6.7 50 mmol/L
Phenol 5 mmol/L
4-Aminoantipyrine 0.3 mmol/L
Cholesterol esterase (CHE) ≥ 200 U/L
Cholesterol oxidase (CHO) ≥ 50 U/L
Peroxidase (POD) ≥ 3 kU/L
Sodium azide 0.95 g/L
ABX Pentra HDL Direct CP is ready-to-use.
Reagent 1
Good’s Buffer
Cholesterol oxidase < 1000 U/L
Peroxidase < 1300 ppm U/L
N,N-bis(4-sulphobutyl)- m-toluidine- disodium (DSBmT) < 1 mM
Accelerator < 1 mM
Preservative < 0.06 %
Reagent 2
Good’s Buffer
Cholesterol esterase 4- < 1500 U/L <
Aminoantipyrine (4-AAP) 1mM
Detergent < 2 %
Restrainer < 0.15%
Preservative < 0.06 %
Ascorbic acid oxidase < 3000 U/L
ABX Pentra LDL Direct CP is ready-to-use.
Reagent 1
MES Buffer (pH 6.3)
Detergent 1 < 1.0 %
Cholesterol Esterase < 1500 U/L
Cholesterol Oxidase < 1500 U/L
Peroxidase < 1300 ppm U/L
4-aminoantipyrine < 0.1 %
Ascorbic Acid Oxidase < 3000 U/L
Preservative
Reagent 2
MES Buffer (pH 6.3)
Detergent 2 < 1.0 %
N,N-bis(4-sulfobutyl)-toluidine, disodium (DsBmT) < 1.0 mM
Preservative
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ABX Pentra Triglycerides CP is ready-to-use.
| Reagent | Pipes free acid | 50 mmol/L |
| --- | --- | --- |
| | Sodium hydroxide | 3.36 g/L |
| | Triton X-100 | 1 ml/L |
| | Magnesium salt | 14.8 mmol/L |
| | p-chlorophenol | 2.7 mmol/L |
| | ATP | 3.15 mmol/L |
| | Sodium azide | 7.99 mmol/L |
| | Potassium ferrocyanide | 10 μmol/L |
| | 4-aminoantipyrine | 0.31 mmol/L |
| | Lipoprotein lipase | ≥2000 U/L |
| | Glycerokinase | ≥500 U/L |
| | Glycerol phosphate Oxidase | ≥4000 U/L |
| | Peroxidase | ≥500 U/L |
ABX Pentra HDL Cal is a lyophilized calibrator. It is a preparation of lyophilized human serum containing lipoproteins from the various lipoprotein classes including high-density lipoproteins.
ABX Pentra LDL Cal is a lyophilized calibrator. It is a preparation of lyophilized human serum containing lipoproteins from the various lipoprotein classes including low-density lipoproteins. • The kit is composed of 2 vials of calibrator (lyophilized for 1 mL)
J. Substantial Equivalence Information:
1. Predicate device name(s):
Roche Cholesterol Reagent
Ultra N-Geneous HDL Cholesterol Reagent
N-Geneous LDL Cholesterol Reagent
Roche Reagent for Triglycerides
Roche Apolipoprotein Standard
Ultra N-Geneous HDL Cholesterol Reagent Calibrator
N-Geneous LDL Cholesterol Reagent Calibrator
Liquichek Lipids Control
2. Predicate 510(k) number(s):
k941573, k021316, k971573, k893973, k021316, k971573, respectively
3. Comparison with predicate:
| | Predicate device (k941573): | Device : |
| --- | --- | --- |
| Device Name | Cholesterol | ABX Pentra Cholesterol CP |
| Manufactured by | Roche, USA | HORIBA ABX, France |
| Instrument | COBAS MIRA chemistry system | ABX PENTRA 400 |
| Analytes | Cholesterol | Cholesterol |
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| | Predicate device (k941573): | Device : |
| --- | --- | --- |
| Device Name | Cholesterol | ABX Pentra Cholesterol CP |
| Method : | Enzymatic photometric test | Enzymatic photometric test |
| Specimen : | Serum
Plasma | Serum
Plasma |
| Certification : | Traceability to the National Reference System for Cholesterol | Traceability to the National Reference System for Cholesterol |
| Component reagent matrices | Single-reagent bottle, ready to use:
REAGENT : 4-Aminoantipyrine, Cholesterol Esterase, Cholesterol Oxidase, Peroxidase, Phenol, buffers, stabilizers, fillers | Mono-reagent cassette, ready to use:
REAGENT : Good’s buffer, Phenol, 4-Aminoantipyrine, Cholesterol Esterase, Cholesterol Oxidase, Peroxidase, Sodium azide |
| Format | Liquid | Liquid |
| Labels | - | Horiba ABX specific label |
| Packaging | Single-reagent bottles
REAGENT : 15 x 12 ml or 4 x 12 mL | Mono-reagent cassette : REAGENT : 99 mL |
| Controls | Commercially available quality control (not included): 2 levels of serum-based controls with known cholesterol values | Recommended quality control material (not included):
ABX Pentra N Control (Normal control)
ABX Pentra P Control (Pathologic control) |
| Calibrators | Commercially available calibrator (not included) | Recommended calibration material (not included): ABX Pentra Multical |
| Performance data : | | |
| Number of tests | - | 380 tests |
| Sample volume | 3 μL/test | 3 μL/test |
| Detection limit | 2 mg/dL | 4 mg/dL |
| Accuracy and Precision | CV Total < 2.4% | CV Total < 3.01% |
| Measuring range | 2 mg/dL – 525 mg/dL | 2.55 mg/dL – 583.26 mg/dL |
| Upper linearity limit | 525 mg/dL (with automatic post-dilution : 1050 mg/dL) | 580 mg/dL |
| Calibration stability | Calibration required monthly | 8 days |
| Closed reagent stability | Until the expiration date when stored at 2-8°C | 24 months at 2-8°C |
| | 30 days at 2-8°C | on-board stability (refrigerated area): 48 days |
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| | Predicate device (k941573): | Device : |
| --- | --- | --- |
| Device Name | Cholesterol | ABX Pentra Cholesterol CP |
| Open Reagent stability | | |
| | Predicate device (k021316): | Device : |
| Device Name | Ultra N-geneous® HDL Cholesterol Reagent | ABX Pentra HDL Direct CP |
| Manufactured by | Genzyme, USA | HORIBA ABX, France |
| Instrument | Automated clinical chemistry analyzer | ABX PENTRA 400 |
| Analytes | High Density Lipoprotein Cholesterol (HDL-C) | High Density Lipoprotein Cholesterol (HDL-C) |
| Method : | Accelerator Selective detergent Methodology | Accelerator Selective detergent Methodology |
| Specimen : | Serum Plasma | Serum Plasma |
| Component reagent matrices | Single reagent bottles, ready to use: REAGENT 1 : Buffer, Cholesterol oxidase, Peroxidase, N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT), Accelerator, Preservative, Ascorbic oxidase REAGENT 2 : Buffer, Cholesterol esterase, 4-Aminoantipyrine (4-AAP), Detergent, Preservative | Bi-reagent cassette, ready to use REAGENT 1 : Good’s buffer, Cholesterol oxidase, Peroxidase, N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT), Accelerator, Preservative REAGENT 2 : Good’s buffer, Cholesterol esterase, 4-Aminoantipyrine (4-AAP), Detergent, Restrainer, Preservative, Ascorbic acid oxidase |
| Format | Liquid | Liquid |
| Labels | - | Horiba ABX specific label |
| Packaging | Single-reagent bottles REAGENT 1 : 1 x 250 mL REAGENT 2 : 1 x 80 mL | Bi-reagent cassette : REAGENT 1 : 62 mL REAGENT 2 : 21 mL |
| Controls | Recommended quality control material (not included): Normal and near the concentrations for decision-making controls | Recommended quality control material (not included): ABX Pentra N Control (Normal control) ABX Pentra P Control (Pathologic control) |
| Calibrators | Recommended calibration material (not included): Ultra N_geneous® HDL Cholesterol Calibrator | Recommended calibration material (not included): ABX Pentra HDL Cal |
| Performance data : | | |
| Number of tests | - | 240 tests |
| Sample volume | 3 μL/test | 3 μL/test |
| Detection limit | - | 1.16 mg/dL |
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| | Predicate device (k941573): | Device : |
| --- | --- | --- |
| Device Name | Cholesterol | ABX Pentra Cholesterol CP |
| Accuracy and Precision | CV Total < 1.5% | CV Total < 3.52% |
| Measuring range | 33.6 mg/dL – 133 mg/dL | 5.4 mg/dL – 151.9 mg/dL |
| Upper linearity limit | 200 mg/dL | 154.8 mg/dL |
| Calibration stability | - | 14 days |
| Closed reagent stability | Until the expiration date when stored at 2-8°C | 22 months at 2-8°C |
| Open Reagent stability | 4 weeks at 2-8°C | on-board stability (refrigerated area): 31 days |
| | Predicate device (k971573): | Device : |
| --- | --- | --- |
| Device Name | N-geneous® LDL Cholesterol Reagent | ABX Pentra LDL Direct CP |
| Manufactured by | Genzyme, USA | HORIBA ABX, France |
| Instrument | Automated clinical chemistry analyzer | ABX PENTRA 400 |
| Analytes | Low Density Lipoprotein Cholesterol (LDL-C) | Low Density Lipoprotein Cholesterol (LDL-C) |
| Method : | Enzymatic colorimetric assay | Enzymatic colorimetric assay |
| Specimen : | SerumPlasma | SerumPlasma |
| Component reagent matrices | Single reagent bottles, ready to use:REAGENT 1 : MES buffer,Detergent 1, CholesterolEsterase, Cholesterol Oxidase,Peroxidase, 4-Aminoantipyrine,Ascorbic Acid Oxidase,PreservativeREAGENT 2 : MES buffer,Detergent 2, N,N-bis(4-sulfobutyl)-m-toluidine-disodium (DSBmT),Preservative | Bi-reagent cassette, ready to useREAGENT 1 : MES buffer,Detergent 1, CholesterolEsterase, Cholesterol Oxidase,Peroxidase, 4-Aminoantipyrine,Ascorbic Acid Oxidase,PreservativeREAGENT 2 : MES buffer,Detergent 2, N,N-bis(4-sulfobutyl)-toluidine-disodium(DSBmT), Preservative, |
| Format | Liquid | Liquid |
| Labels | - | Horiba ABX specific label |
| Packaging | Single-reagent bottles:REAGENT 1 : 1 x 30 mLREAGENT 2 : 1 x 10 mL | Bi-reagent cassette:REAGENT 1 : 28 mLREAGENT 2 : 10 mL |
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| | Predicate device (k971573): | Device : |
| --- | --- | --- |
| Device Name | N-geneous® LDL Cholesterol Reagent | ABX Pentra LDL Direct CP |
| | | |
| Controls | Commercially available quality control material (not included) | Recommended quality control material (not included):
ABX Pentra N Control (Normal control)
ABX Pentra P Control (Pathologic control) |
| Calibrators | Recommended calibration material (not included):
N_geneous® LDL Cholesterol Calibrator | Recommended calibration material (not included):
ABX Pentra LDL Cal |
| Performance data : | | |
| Number of tests | - | 100 tests |
| Sample volume | 3 μL/test | 2.4 μL/test |
| Detection limit | - | 1.55 mg/dL |
| Analytical sensitivity | 0.278 mg/dL | - |
| Accuracy and Precision | CV Total < 2.27% | CV Total < 6.39% |
| Measuring range | 6.6 mg/dL – 992 mg/dL | 1.35 mg/dL – 369.39 mg/dL |
| Upper linearity limit | 992 mg/dL | 387 mg/dL |
| Calibration stability | - | 12 days |
| Closed reagent stability | Until the expiration date when stored at 2-8°C | 18 months at 2-8°C |
| Open Reagent stability | 4 weeks at 2-8°C | on-board stability (refrigerated area): 97 days |
| | Predicate device (k893973): | Device : |
| --- | --- | --- |
| Device Name | Triglycerides | ABX Pentra Triglycerides CP |
| Manufactured by | Roche, USA | HORIBA ABX, France |
| Instrument | COBAS chemistry system | ABX PENTRA 400 |
| Analytes | Triglycerides | Triglycerides |
| Method : | Enzymatic colorimetric assay | Enzymatic colorimetric assay |
| Specimen : | Serum
Plasma | Serum
Plasma |
| Component reagent matrices | Single reagent bottles, the combined reagents contain the | Mono-reagent cassette, ready to use |
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| | Predicate device (k893973): | Device : |
| --- | --- | --- |
| Device Name | Triglycerides | ABX Pentra Triglycerides CP |
| | following components: ATP, 4-Aminoantipyrine, Glycerol kinase, Glycerol phosphate oxidase, Lipases, Peroxidase, Sodium N-Ethyl-N-(3-Sulfopropyl)-m-anisidine (ESPAS), buffers, stabilizers, fillers | REAGENT : Pipes free acid, Sodium hydroxide, Triton X-100, Magnesium salt, p-chlorophenol, ATP, Sodium azide, Potassium ferrocyanide, 4-Aminoantipyrine, Lipoprotein lipase, Glycerokinase, Glycerol phosphate Oxidase, Peroxidase |
| Format | Liquid | Liquid |
| Labels | - | Horiba ABX specific label |
| Packaging | Kit composed of single-reagent bottles REAGENT 1 : 2 x 80 mL REAGENT 2 : 2 x 40 ml | Mono-reagent cassette : REAGENT : 99 mL |
| Controls | Commercially available quality control (not included): 2 levels | Recommended quality control material (not included): ABX Pentra N Control (Normal control) ABX Pentra P Control (Pathologic control) |
| Calibrators | Commercially available calibrator (not included) | Recommended calibration material (not included): ABX Pentra Multical |
| Additional Reagents | - | Cleaning solution (not included): ABX Pentra Clean-Chem CP / ABX Pentra Clean-Chem 99 CP |
| Performance data : | | |
| Number of tests | - | 327 tests |
| Sample volume | 4 μL/test | 3 μL/test |
| Detection limit | - | 7 mg/dL |
| Accuracy and Precision | CV Total < 3.6% | CV Total < 2.83% |
| Measuring range | 10 mg/dL - 662 mg/dL | 3.1 mg/dL - 1434 mg/dL |
| Upper linearity limit | 900 mg/dL (with automatic post-dilution : 1800 mg/dL) | 1470 mg/dL, with an automatique post-dilution : 5580 mg/dL |
| Calibration stability | - | 14 days |
| Closed reagent stability | Until the expiration date when stored at 2-8°C | 16 months at 2-8°C |
| Open Reagent | Combined reagent is stable: 1 year at 2-8°C 60 days at room temperature | on-board stability (refrigerated area): 48 days |
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| | Predicate device (k893973): | Device : |
| --- | --- | --- |
| Device Name | Triglycerides | ABX Pentra Triglycerides CP |
| stability | (15-25°C) | |
| | Predicate device (k021316): | Device : |
| --- | --- | --- |
| Device Name | Ultra N-geneous® HDL Cholesterol Calibrator | ABX Pentra HDL Cal |
| Manufactured by | Genzyme, USA | HORIBA ABX, France |
| Instrument | Chemistry systems | ABX PENTRA 400 |
| Method : | Calibration of Genzyme Ultra N- geneous HDL Cholesterol assay | Calibration of HORIBA ABX HDL Cholesterol measurement method |
| Component matrices | Vials (lyophilized) | Vials (lyophilized) |
| | Human serum based | Human serum based, with preservative |
| Calibrated molecules | HDL Cholesterol | HDL Cholesterol |
| Format | Lyophilized | Lyophilized |
| Labels | - | Horiba ABX specific label |
| Packaging | Kit composed of : 1 x 1 mL vial | Kit composed of : 2 x 1 mL vial |
| Performance data : | | |
| Calibration value | - Assigned by procedures traceable to the National Reference System for Cholesterol (NRS/CHOL) | - Assigned by procedures traceable to the National Reference System for Cholesterol (NRS/CHOL) |
| | - | - The concentration of component is lot specific |
| | - The concentration of component is given on the vial label | - The concentration is given in the enclosed annex |
| Closed stability | Up to the expiration date at 2-8°C | 24 months at 2-8°C |
| Open stability | 14 days at 2-8°C | 14 days at 2-8°C |
| | 4 weeks at -70°C | 4 weeks at -70°C |
| | Predicate device (k971573): | Device : |
| --- | --- | --- |
| Device Name | N-geneous™ LDL Cholesterol Calibrator | ABX Pentra LDL Cal |
| Manufactured by | Genzyme, USA | HORIBA ABX, France |
| Instrument | Chemistry systems | ABX PENTRA 400 |
| Method : | Calibration of Genzyme N- | Calibration of HORIBA ABX |
| | geneous HDL Cholesterol assay | |
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| | Predicate device (k971573): | Device : |
| --- | --- | --- |
| Device Name | N-geneous™ LDL Cholesterol Calibrator | ABX Pentra LDL Cal |
| | geneous LDL Cholesterol assay | LDL Cholesterol measurement method |
| Component matrices | Vials (lyophilized) | Vials (lyophilized) |
| | Human serum based | Human serum based, with preservative |
| Calibrated molecules | LDL Cholesterol | LDL Cholesterol |
| Format | Lyophilized | Lyophilized |
| Labels | - | Horiba ABX specific label |
| Packaging | Kit composed of : 1 x 1 mL vial | Kit composed of : 2 x 1 mL vial |
| Performance data : | | |
| Calibration value | - Assigned by procedures traceable to the National Reference System for Cholesterol (NRS/CHOL) | - Assigned by procedures traceable to the National Reference System for Cholesterol (NRS/CHOL) |
| | - | - The concentration of component is lot specific |
| | - The concentration of component is given on the vial label | - The concentration is given in the enclosed annex |
| Closed stability | Up to the expiration date at 2-8°C | 24 months at 2-8°C |
| Open stability | 2 weeks at 2-8°C | 2 weeks at 2-8°C |
K. Standard/Guidance Document Referenced (if applicable):
CLSI - Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline-Second Edition - EP05-A2
CLSI - Evaluation of the Linearity of Quantitative Analytical Methods; Approved Guideline - EP06-A
CLSI - Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition - EP09-A2
L. Test Principle:
ABX PENTRA Cholesterol CP
"CHOD-PAP": enzymatic photometric test.
Determination of cholesterol after enzymatic hydrolysis and oxidation (3,4). The colorimetric indicator is quinoneimine which is generated from 4-aminoantipyrine and phenol by hydrogen peroxide under the catalytic action of peroxidase (Trinder's reaction)
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# ABX PENTRA HDL Direct CP
The assay is a homogeneous method for directly measuring HDL-C levels in serum or plasma without the need for any off-line pretreatment or centrifugation steps.
The method is in a two reagent format and depends on the properties of a unique detergent, as illustrated. This method is based on accelerating the reaction of cholesterol oxidase (CO) with non-HDL unesterified cholesterol and dissolving HDL selectively using a specific detergent.
In the first reagent, non-HDL unesterified cholesterol is subject to an enzyme reaction and the peroxide generated is consumed by a peroxidase reaction with DSBmT yielding a colorless product.
The second reagent consists of a detergent capable of solubilizing HDL specifically, cholesterol esterase (CE) and chromagenic coupler to develop color for the quantitative determination of HDL-C.
# ABX PENTRA LDL Direct CP
The assay is an homogeneous method for directly measuring LDL-C levels in serum or plasma, without the need for any off-line pretreatment or centrifugation steps.
The method is in a two reagent format and depends on the properties of a unique detergent. This detergent (Reagent 1) solubilizes only the non LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non color forming reaction. A second detergent (Reagent 2) solubilizes the remaining LDL particles and a chromogenic coupler allows for color formation. The enzyme reaction with LDL-C in the presence of the coupler produces color that is proportional to the amount of LDL cholesterol present in the sample.
# ABX PENTRA Triglycerides CP
Enzymatic determination of triglycerides according to the following reactions:
Triglycerides + H₂O Lipoprotein lipase → Glycerol + fatty acids
Glycerol + ATP Glycerol-3-phosphate + ADP → Glycerol-3-phosphate Oxidase
Glycerol-3-Phosphate + O₂ → H₂O₂ + DHAP
Peroxidase
2H₂O₂ + 4-AAP + p-Chlorophenol Quinoneimine + 4H₂O
(DHAP = Dihydroxyacetone phosphate, 4-AAP = 4-aminoantipyrine)
# M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
ABX PENTRA Cholesterol CP
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Two control materials and three specimens were tested 20times in a single run. The results are presented in the table below.
| | Mean value mg/dL | CV % |
| --- | --- | --- |
| Normal control | 113 | 0.82 |
| Pathological control | 186 | 0.74 |
| Specimen 1 | 117 | 1.21 |
| Specimen 2 | 191 | 0.53 |
| Specimen 3 | 389 | 0.62 |
In accordance with CLSI guideline EP-5A, two control materials and two specimens were tested in duplicate for 20 days, two times a day $(N = 80)$ . The results are presented in the table below.
| | Mean value mg/dL | CV % |
| --- | --- | --- |
| Normal control | 109 | 2.96 |
| Pathological control | 183 | 2.34 |
| Specimen 1 | 170 | 2.80 |
| Specimen 2 | 250 | 3.01 |
# ABX PENTRA HDL Direct CP
Two control materials and three specimens were tested 20times in a single run. The results are presented in the table below.
| | Mean value mg/dL | CV % |
| --- | --- | --- |
| Normal control | 35.82 | 1.29 |
| Pathological control | 81.72 | 0.79 |
| Specimen 1 | 27.94 | 1.32 |
| Specimen 2 | 48.59 | 1.91 |
| Specimen 3 | 97.39 | 0.62 |
In accordance with CLSI guideline EP-5A, two control materials and two specimens were tested in duplicate for 20 days, two times a day $(N = 80)$ . The results are presented in the table below.
| | Mean value mg/dL | CV % |
| --- | --- | --- |
| Normal control | 35.83 | 2.88 |
| Pathological control | 80.35 | 3.06 |
| Specimen 1 | 47.07 | 3.52 |
| Specimen 2 | 80.16 | 2.69 |
# ABX PENTRA LDL Direct CP
Two control materials and three specimens were tested 20times in a single run. The results are presented in the table below.
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| | Mean value mg/dL | CV % |
| --- | --- | --- |
| Normal control | 61.26 | 1.01 |
| Pathological control | 75.08 | 2.82 |
| Specimen 1 | 111.26 | 0.91 |
| Specimen 2 | 141.45 | 1.00 |
| Specimen 3 | 191.16 | 0.63 |
In accordance with CLSI guideline EP-5A, two control materials and two specimens were tested in duplicate for 20 days, two times a day (N=80). The results are presented in the table below.
| | Mean value mg/dl | CV % |
| --- | --- | --- |
| Normal control | 60.64 | 5.59 |
| Pathological control | 74.27 | 6.39 |
| Specimen 1 | 156.58 | 3.94 |
| Specimen 2 | 191.62 | 4.04 |
## ABX PENTRA Triglycerides CP
Two control materials and three specimens were tested 20 times in a single run. The results are presented in the table below.
| | Mean value mg/dL | CV % |
| --- | --- | --- |
| Normal control | 126 | 2.52 |
| Pathological control | 214 | 0.82 |
| Specimen 1 | 60 | 2.83 |
| Specimen 2 | 108 | 1.84 |
| Specimen 3 | 232 | 1.00 |
In accordance with CLSI guideline EP-5A, two control materials and two specimens were tested in duplicate for 20 days, two times a day (N=80). The results are presented in the table below.
| | Mean value mg/dL | CV % |
| --- | --- | --- |
| Normal control | 128 | 1.91 |
| Pathological control | 216 | 1.70 |
| Specimen 1 | 132 | 1.57 |
| Specimen 2 | 243 | 1.37 |
## b. Linearity/assay reportable range:
The reagent linearity is determined according to the recommendations found in the CLSI (NCCLS), EP6-A protocol. As a result of the testing, the following represent the linear range for each assay.
## ABX PENTRA Cholesterol CP
Low linearity: 4 mg/dL
High linearity: 580 mg/dL
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# ABX PENTRA HDL Direct CP
Low linearity: 1.16 mg/dL
High linearity: 154.8 mg/dL.
# ABX PENTRA LDL Direct CP
Low linearity: 1.55 mg/dL
High linearity: 387 mg/dL
# ABX PENTRA Triglycerides CP
Low linearity: 7 mg/dL
High linearity: 1470 mg/dL, with automatic post-dilution: 5880 mg/dL
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Calibrators for Cholesterol and Triglyceride, and controls for Cholesterol, HDL, LDL and Triglyceride see k052007.
# ABX PENTRA and HDL, LDL Calibrators and L/H Controls
Real time stability at 2-8°C was investigated for Calibrator, High Controls and Low Controls.
Real time stability study on reconstituted material was performed at regular intervals over a period providing data to support claims at 2-8°C (All) and –20°C (Lipoproteins), and –70°C (HDL).
Traceability
# ABX PENTRA Cholesterol CP
## Certification
Traceability to the National Reference System for Cholesterol was established by performing a direct comparison with the cholesterol reference method using human specimens that cover the National Cholesterol Education Program (NCEP) medical decision points. The ability to meet the NCEP’s performance criteria for accuracy was demonstrated through testing and certification by the Cholesterol Reference Method Laboratory Network (CRMLN).
The results of the direct comparison and precision studies are as follows:
Among-run %CV: 1.5%
Average %Bias: -2.5%
Total Error: 5.6%
d. Detection limit:
# ABX PENTRA Cholesterol CP:
Minimum Detection Limit (MDL) is calculated from 30 measurements of saline. Formula: MDL = mean of measurements + 4.65 SD (mean of measurement = 0 when negative)
From the MDL value, the minimum detection limit assigned for this method is 4 mg/dL.
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ABX PENTRA HDL Direct CP
From the MDL value, the test range low assigned for this method is 1.16 mg/dL.
ABX PENTRA LDL Direct CP
From the MDL value, the test range low assigned for this method is 1.55 mg/dL.
ABX PENTRA Triglycerides CP
From the MDL value, the test range low assigned for this method is 7 mg/dL.
e. Analytical specificity:
ABX PENTRA Cholesterol CP
Hemoglobin: No significant influence is observed up to 336 mg/dL
Triglycerides: No significant influence is observed up to 612.5 mg/dL
(as Intralipid®, representative of lipemia)
Total Bilirubin: No significant influence is observed up to 20.5 mg/dL
Direct Bilirubin: No significant influence is observed up to 6.8 mg/dL
Other limitations are given by way of literature reference known to affect this methodology.
ABX PENTRA HDL Direct CP
Hemoglobin: No significant influence is observed up to 479 mg/dL.
Triglycerides: No significant influence is observed up to 612.5 mg/dL.
(as Intralipid®, representative of lipemia)
Total Bilirubin: No significant influence is observed up to 11.7 mg/dL.
Direct Bilirubin: No significant influence is observed up to 28.1 mg/dL
ABX PENTRA LDL Direct CP
Hemoglobin: No significant influence is observed up to 336 mg/dL.
Triglycerides: No significant influence is observed up to 612.5 mg/dL.
(as Intralipid®, representative of lipemia)
Total Bilirubin: No significant influence is observed up to 29.2 mg/dL.
Direct Bilirubin: No significant influence is observed up to 10.8 mg/dL
ABX PENTRA Triglycerides CP
Hemoglobin: No significant influence is observed up to 500 mg/dL
Total Bilirubin: No significant influence is observed up to 22.5 mg/dL
Direct Bilirubin: No significant influence is observed up to 22.5 mg/dL
f. Assay cut-off:
Not Applicable
2. Comparison studies:
a. Method comparison with predicate device:
ABX PENTRA Cholesterol CP
135 patient samples (serum) are correlated with a commercial reagent taken as reference according to the recommendations found in the
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CLSI (NCCLS), EP9-A2 protocol. Values ranged from 2.55 to 583.26 mg/dL.
The equation for the regression line obtained is:
$$Y = 0.95x + 1.90$$
with a correlation coefficient $$r^2 = 0.9943$$.
## ABX PENTRA HDL Direct CP
121 patient samples are correlated with a commercial reagent taken as reference according to the recommendations found in the CLSI (NCCLS), EP9-A2 protocol. Values ranged from 3.5 to 155.3 mg/dL
The equation for the regression line obtained is:
$$Y = 0.91x + 1.98$$
with a correlation coefficient $$r^2 = 0.9768$$
## ABX PENTRA LDL Direct CP
122 patient samples are correlated with a commercial reagent taken as reference according to the recommendations found in the CLSI (NCCLS), EP9-A2 protocol. Values ranged from 0.3 to 385.6 mg/dL
The equation for the regression line obtained is:
$$Y = 0.96x - 0.21$$, with a correlation coefficient $$r^2 = 0.9963$$
## ABX PENTRA Triglycerides CP
135 patient samples are correlated with a commercial reagent taken as reference according to the recommendations found in the CLSI (NCCLS), EP9-A2 protocol. Values ranged from 8.2 to 274.2 mg/dL
The equation for the regression line obtained is:
$$Y = 0.99x + 0.20$$, with a correlation coefficient $$r^2 = 0.9994$$
## b. Matrix comparison:
### ABX PENTRA Cholesterol CP
To demonstrate equivalence of Cholesterol results in serum and Plasma Heparin-Lithium samples, comparison study was performed. 40 samples (103-373 mg/dL) were evaluated on Pentra 400 analyzer using ABX Pentra Cholesterol CP reagent.
The equation for the regression line obtained is:
$$Y = 0.9903x + 1.8467$$
with a correlation coefficient $$r = 0.996$$
### ABX PENTRA HDL Direct CP
To demonstrate equivalence of HDL Cholesterol results in serum and Plasma Heparin-Lithium samples, comparison study was performed. 43 samples (35-118 mg/dL) were evaluated on Pentra 400 analyzer using ABX Pentra HDL Direct CP reagent.
The equation for the regression line obtained is:
$$Y = 0.9467x + 1.5252$$
with a correlation coefficient $$r = 0.996$$
### ABX PENTRA LDL Direct CP
To demonstrate equivalence of LDL Cholesterol results in serum and Plasma Heparin-Lithium samples, comparison study was performed. 41 samples (53-362 mg/dL) were evaluated on Pentra 400 analyzer using ABX Pentra LDL Direct CP reagent.
The equation for the regression line obtained is:
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$$
Y = 0.9681 x + 0.2352 \text{ with a correlation coefficient } r = 0.999
$$
## ABX PENTRA Triglycerides CP
To demonstrate equivalence of Triglycerides results in serum and Plasma Heparin-Lithium samples, comparison study was performed. 41 samples (47-728 mg/dL) were evaluated on Pentra 400 analyzer using ABX Pentra Triglycerides CP reagent.
The equation for the regression line obtained is:
$$
Y = 0.9694 x - 1.7717 \text{ with a correlation coefficient } r = 0.999
$$
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 Cholesterol CP
Desirable: < 200 mg/dL
Borderline high risk: 200 - 239 mg/dL
High risk: > 240 mg/dL
Cholesterol Education Program (NCEP) medical decision points
## ABX PENTRA HDL Direct CP
Men: 30 - 70 mg/dL
Women: 30 - 85 mg/dL (literature)
According to the NCEP, HDL values greater than or equal to 40 mg/dL are considered desirable, and values greater than or equal to 60 mg/dL are considered to offer some protection against coronary heart disease. Values below 40 mg/dL are considered to be a significant independent risk factor for coronary heart disease.
## ABX PENTRA LDL Direct CP
The following NCEP cut-points for patient classification are used for the prevention and management of coronary heart disease.
| LDL Cholesterol | Classification |
| --- | --- |
| < 130 mg/dL | Desirable |
| 130-159 mg/dL | Borderline High Risk |
| 160 mg/dL | High Risk |
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# ABX PENTRA Triglycerides CP
The following NCEP cut- points been classified according to the risk of developing cardiovascular diseases:
Normal: < 150 mg/dL
Low risk: 150 - 200 mg/dL
High: 200 - 500 mg/dL
Extremely high: > 500 mg/dL
## 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.
