ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
Device Facts
| Record ID | K052007 |
|---|---|
| Device Name | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) |
| Applicant | Horiba Abx |
| Product Code | CFR · Clinical Chemistry |
| Decision Date | Dec 16, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The ABX PENTRA Glucose HK CP is a ready-to-use reagent for use on the ABX Pentra 400 system for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose hexokinase method by colorimetry. The ABX PENTRA Glucose PAP CP is a ready-to-use reagent for use on the ABX Pentra 400 system for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose oxidase method by colorimetry. The ABX PENTRA Sodium – E is an electrode for use on the I.S.E. module of the ABX Pentra 400 system for quantitative in vitro diagnostic determination of Sodium in human serum, plasma and urine. The ABX PENTRA Potassium – E is an electrode for use on the I.S.E. module of the ABX Pentra 400 system for quantitative in vitro diagnostic determination of Potassium in human serum, plasma and urine. The ABX PENTRA Chloride – E is an electrode for use on the I.S.E. module of the ABX Pentra 400 system for quantitative in vitro diagnostic determination of Chloride in human serum, plasma and urine. The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes. The option of an I.S.E. (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Chloride, and Potassium by potentiometry using ion selective electrode. The ABX PENTRA Multical is a calibrator for use in the calibration of specified quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers. The ABX PENTRA Standard 1, Standard 2 and Reference reagents are for use in the calibration of quantitative determination of sodium, potassium and chloride on ABX PENTRA 400 ISE module. The ABX PENTRA N Control and P Control are for use in quality control by monitoring accuracy and precision for specified quantitative methods.
Device Story
Benchtop clinical chemistry analyzer; performs automated pipetting, mixing, heating, and measurement. Inputs: primary tubes or sample cups containing serum, plasma, or urine. Principles: spectrophotometry (colorimetry/turbidimetry) for glucose; potentiometry (ion-selective electrodes) for electrolytes. Features: random access, bar-code sample/reagent identification, refrigerated reagent storage, and fibrin detection. Output: quantitative analyte concentrations displayed to healthcare providers for clinical decision-making. Operated by laboratory personnel in clinical environments. Benefits: replaces manual analytical procedures with high-throughput, automated, standardized testing.
Clinical Evidence
Bench testing only. Precision/reproducibility evaluated per NCCLS EP5-A2; linearity per NCCLS EP6-A; method comparison against commercial reference reagents per NCCLS EP9-A2 (N=103-152 samples). Correlation coefficients (r²) ranged from 0.9651 to 0.9991. Analytical specificity tested against hemoglobin, triglycerides, and bilirubin; no significant interference observed within specified limits.
Technological Characteristics
Benchtop discrete photometric analyzer. Measuring principles: absorbance photometry and potentiometry (ISE). Throughput: 150-300 tests/hour. Connectivity: Barcode reader for reagent/sample identification. Safety standards: EN 61010-1, EN 61326 (EMC), UL 3101-1, CSA C22.2 No. 1010-1.
Indications for Use
Indicated for quantitative in vitro diagnostic determination of glucose (serum/plasma) and sodium, potassium, and chloride (serum/plasma/urine) in clinical settings using the ABX Pentra 400 analyzer.
Regulatory Classification
Identification
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Special Controls
*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, 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 Cobas Mira Plus/Option I.S.E module (K920402/K963627)
- Cobas Reagent for Glucose Rapid (K801297)
- Roche Calibrator for Automated Systems (C.f.a.s.) (K041227)
- Roche Precinorm Universal (K041227)
Related Devices
- K101741 — DIATRON PICTUS 400 · Diatron Group · Jan 25, 2011
- K103788 — PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT · HORIBA ABX SAS · Nov 8, 2011
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
K052007
B. Purpose for Submission:
The submission is for clearance of the ABX Pentra 400 Clinical Chemistry Analyzer and ABX Pentra Glucose reagents and Optional I.S.E. module for Sodium, Potassium and Chloride with associated calibrators (manufactured by Roche) and controls (manufactured by Roche).
C. Measurand:
Glucose, Sodium, Potassium and Chloride
D. Type of Test:
Quantitative
E. Applicant:
HORIBA ABX
F. Proprietary and Established Names:
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
G. Regulatory Information:
1. Regulation section:
21 CFR §862.1345-Glucose test system.
21 CFR §862.1665-Sodium test system.
21 CFR §862.1600-Potassium test system.
21 CFR §862.1170-Chloride test system.
21 CFR §862.1150-Calibrator.
21 CFR §862.1660-Quality control material (assayed and unassayed).
21 CFR §862.2160-Discrete Photometric Chemistry Analyzer for Clinical Use
2. Classification:
2,2,2,2,2,1 reserved, and 1 respectively
3. Product code:
CFR-HEXOKINASE, GLUCOSE
JGS-ELECTRODE, ION SPECIFIC, SODIUM
CEM-ELECTRODE, ION SPECIFIC, POTASSIUM
CGZ-ELECTRODE, ION-SPECIFIC, CHLORIDE
JIX-CALIBRATOR, MULTI-ANALYTE MIXTURE
JJY-MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED AND UNASSAYED)
JJE-ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
4. Panel:
Chemistry (75)
H. Intended Use:
1. Intended use(s):
See indications for use below
2. Indication(s) for use:
The ABX PENTRA Glucose HK CP is a ready-to-use reagent for use on the
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ABX Pentra 400 system for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose hexokinase method by colorimetry.
The ABX PENTRA Glucose PAP CP is a ready-to-use reagent for use on the ABX Pentra 400 system for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose oxidase method by colorimetry.
The ABX PENTRA Sodium – E is an electrode for use on the I.S.E. module of the ABX Pentra 400 system for quantitative in vitro diagnostic determination of Sodium in human serum, plasma and urine.
The ABX PENTRA Potassium – E is an electrode for use on the I.S.E. module of the ABX Pentra 400 system for quantitative in vitro diagnostic determination of Potassium in human serum, plasma and urine.
The ABX PENTRA Chloride – E is an electrode for use on the I.S.E. module of the ABX Pentra 400 system for quantitative in vitro diagnostic determination of Chloride in human serum, plasma and urine.
The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use.
The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity.
The device is intended for use in conjunction with certain materials to measure a variety of analytes.
The option of an I.S.E. (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Chloride, and Potassium by potentiometry using ion selective electrode.
The ABX PENTRA Multical is a calibrator for use in the calibration of specified quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA Standard 1, Standard 2 and Reference reagents are for use in the calibration of quantitative determination of sodium, potassium and chloride on ABX PENTRA 400 ISE module.
The ABX PENTRA N Control and P Control are for use in quality control by monitoring accuracy and precision for specified quantitative methods.
3. Special conditions for use statement(s):
For prescription use
4. Special instrument requirements:
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
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I. Device Description:
The ABX PENTRA 400 is a benchtop clinical chemistry analyzer using two measuring principles absorbance and ion selective electrodes.
The instrument may be summarized as follows:
- Multi-parametric (up to 52 simultaneous tests + 3 ISE tests)
- Patient per patient
- On routine or Stat
- 150 to 300 tests / hour (in single or bi-reaction mode) (analytical cycle of 12 seconds)
- random access working on primary tubes or sample cups
- ABX PENTRA reagent cassettes are compact and ready-to-use.
- on board bar-code readers are used to identify newly loaded reagent cassettes and samples for patient identification
The ABX PENTRA 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).
ABX Pentra Glucose HK CP - Bi-reagent cassette, ready to use REAGENT 1: NAD, ATP, Buffer, Sodium azide REAGENT 2: hexokinase, G-6-PDH, Magnesium sulphate, Sodium azide.
ABX Pentra Glucose PAP CP - Single-reagent cassette, ready to use REAGENT: Phenol, 4-aminoantipyrine, glucose oxidase, peroxidase, Sodium azide, Buffer.
ABX PENTRA 400 I.S.E. MODULE -
- Sodium Electrode ABX Pentra Sodium-E: glass membrane selective to Na+ ions
- Potassium Electrode ABX Pentra Potassium-E: plastic membrane selective to K+ ions
- Chloride Electrode ABX Pentra Chloride-E: plastic membrane selective to Cl- ions
J. Substantial Equivalence Information:
1. Predicate device name(s):
Roche Cobas Mira Plus/Option I.S.E module, Cobas Reagent for Glucose Rapid, Roche Calibrator for Automated Systems (C.f.a.s.) and Roche Precinorm Universal
2. Predicate 510(k) number(s):
K920402/ K963627, K801297 and K041227 respectively
3. Comparison with predicate:
| | Predicate device : | Device : |
| --- | --- | --- |
| Device Name | Cobas MIRA Plus | ABX PENTRA 400 |
| Instrument Type | Tabletop analyzer | Benchtop |
| Separate Work Station | No | Integrated |
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| | Predicate device : | Device : |
| --- | --- | --- |
| Device Name | Cobas MIRA Plus | ABX PENTRA 400 |
| Open/Closed reagent system | Open | Open/Closed system |
| Touch Screen Interface | No | Yes |
| I.S.E. Optional/Not optional | Optional | Optional |
| ISE parameters | Na, K, Cl | Na, K, Cl |
| Potentiometry | Direct & indirect | Direct & indirect |
| Sample volume in μl | Direct: 85/ Indirect: 20 | 60 for 3 parameters |
| Sodium Electrode | Glass membrane selective to Na+ ions | Glass membrane selective to Na+ ions |
| Potassium Electrode | PVC valinomycin membrane selective to K+ ions | Plastic membrane selective to K+ ions |
| Chloride Electrode | Liquid membrane selective to Cl- ions | Plastic membrane selective to Cl- ions |
| Type of samples | Serum | Serum |
| | Plasma | Plasma |
| | Urine | Urine |
| Throughput | | |
| Without I.S.E. | 132 | 300 |
| With I.S.E. | 200 | up to 420 |
| Parameters on board | 30 | 52 (Mono, Bi-reagents cassettes) |
| Refrigerated | 20 | 44 |
| Non refrigerated | 10 | 8 |
| Sample treatment | | |
| Sample capacity | 16 tubes or 30 cups/rack | 60 (6 racks of 10 samples) |
| Real patient sample ID | Yes | Yes |
| Bar-Code reader | Integrated | Integrated |
| Primary tube types | 1, 3, 5, 7, 10 mL | 1, 3, 5, 7, 10 mL |
| Sample volume | 2 to 95 μl | 2 to 95μl |
| Dilution of patient sample | Yes | Yes |
| Fibrin detecting device | No | Yes |
| Disposable tips | Washable needles | Washable needles |
| Automatic standard curve dilution | No | Yes |
| Reagents | | |
| Type of reagents | Liquid | Liquid |
| Disposable/Washable cuvettes | Disposable cuvettes | Disposable cuvettes |
| Total reaction volume | Mini: 100 μl, Maxi: 250 μl | Mini: 150 μl, Maxi: 600 μl |
| Maximum number of reagents per test | 4 | 3 reagents + 5 buffers |
| Principles of Measurement | Spectrophotometry : Monochromatic measurement of light absorbance (Xenon (flash) lamp) Potentiometry : Direct (Serum or Plasma) and Indirect (Urine) | Spectrophotometry : Colorimetry and Turbidimetry : parallel bi-chromatic measurement of light absorbance (Tungsten halogen lamp) Potentiometry : Direct (Serum or Plasma) and Indirect (Urine) |
| Measurement | | |
| Photometer type : light source | Xenon (flash) | Halogen |
| Type of measurement | Mono | Mono, Bi chromatic |
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| | Predicate device : | Device : |
| --- | --- | --- |
| Device Name | Cobas MIRA Plus | ABX PENTRA 400 |
| Dimensions (HxWxD) | 73 x 58 x 54 cm | 100 x 65 x 57 cm |
| Weight | 87 kg | 120 kg |
| Calibrators | Same | Same - Horiba labeling specific |
| Controls | Same | Same - Horiba labeling specific |
| | Predicate device : | Device : |
| --- | --- | --- |
| Device Name | Cobas Reagent for Glucose Rapid | ABX Pentra Glucose HK CP |
| Instrument | MIRA Plus | ABX PENTRA 400 |
| Analytes | Glucose | Glucose |
| Method : | Enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase | Identical |
| Specimen : | Serum Plasma | Serum Plasma |
| Component reagent matrices | Single-reagent bottle, ready to use REAGENT : ATP, NAD, Magnesium, Hexokinase, G-6-PD, Sodium azide, Buffers, preservatives, stabilizers | Bi-reagent cassette, ready to use REAGENT 1 : NAD, ATP, Buffer, Sodium azide REAGENT 2 : hexokinase, G-6-PDH, Magnesium sulphate, Sodium azide |
| Format | Liquid | Liquid |
| Labels | - | Horiba ABX specific label |
| Notice | - | Horiba ABX specific notice |
| Packaging | Single-reagent bottle REAGENT : 2 x 100 mL | Bi-reagent cassette : REAGENT 1 : 46 mL REAGENT 2 : 12 mL |
| Calibrators | Same | Same - Horiba labeling specific |
| Controls | Same | Same - Horiba labeling specific |
| | Predicate device : | Device : |
| --- | --- | --- |
| Device Name | Cobas Reagent for Glucose Rapid | ABX Pentra Glucose PAP CP |
| Instrument | MIRA Plus | ABX PENTRA 400 |
| Analytes | Glucose | Glucose |
| Method : | Enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase | Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method) |
| Specimen : | Serum Plasma | Serum Plasma |
| Component reagent matrices | Single-reagent bottle, ready to use | Single-reagent cassette, ready to use |
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| | Predicate device : | Device : |
| --- | --- | --- |
| Device Name | Cobas Reagent for Glucose Rapid | ABX Pentra Glucose PAP CP |
| | REAGENT : ATP, NAD, Magnesium, Hexokinase, G-6-PD, Sodium azide, Buffers, preservatives, stabilizers | REAGENT : Phenol, 4-aminoantipyrine, glucose oxidase, peroxidase, Sodium azide, Buffer |
| Format | Liquid | Liquid |
| Labels | - | Horiba ABX specific label |
| Notice | - | Horiba ABX specific notice |
| Packaging | Single-reagent bottle REAGENT : 2 x 100 mL | Single-reagent cassette : REAGENT : 99 mL |
| Calibrators | Same | Same - Horiba labeling specific |
| Controls | Same | Same - Horiba labeling specific |
# K. Standard/Guidance Document Referenced (if applicable):
- IEC 61010-1: safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
- EN 61326: standard for Electrical equipment for measurement, control and laboratory use - EMC requirements
- UL 3101 - 1 / CSA - C22.2 No. 1010-1: Safety Requirements for Electrical Equipment for measurement, control, and laboratory use, Part 1: General Requirements
- Guidance for Industry - Content of Premarket submissions for Software Contained in Medical Devices
- Guidance for Industry - In Vitro Diagnostics Glucose Test System
- Guidance for Industry - In Vitro Diagnostics Chloride Test System
- Guidance for Industry - In Vitro Diagnostics Sodium Test System
- Guidance for Industry - In Vitro Diagnostics Potassium Test System
- Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators
- Guidance for Industry - Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material
- CLSI/NCCLS - EP05-A2 - Evaluation of Precision Performance of Clinical Chemistry Devices
- CLSI/NCCLS - EP06-A - Evaluation of the Linearity of Quantitative Analytical Methods
- CLSI/NCCLS - EP09-A - Method Comparison and Bias Estimation Using Patient Samples
# L. Test Principle:
ABX Pentra Glucose HK CP - Enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase.
ABX Pentra Glucose PAP CP - Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method).
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ABX PENTRA 400 I.S.E. MODULE for Sodium Potassium and Chloride - Electrical potential measured between the reference electrode flowed by a reference solution and the specific selective electrode flowed by the sample. Slopes of the electrodes are determined with two standard solutions of known concentrations and stored by the instrument.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
ABX PENTRA Glucose HK CP
**Repeatability (within-run precision)**
3 specimens of low, medium and high concentration and 2 controls are tested 20 times
| | Mean value mg/dL | CV % |
| --- | --- | --- |
| Normal control | 96.90 | 0.66 |
| Pathological control | 251.90 | 0.81 |
| Specimen 1 | 31.15 | 1.18 |
| Specimen 2 | 94.35 | 0.52 |
| Specimen 3 | 253.45 | 0.74 |
**Reproducibility (total precision)**
2 specimens of low and high levels and 2 controls are tested in duplicate for 20 days (2 series per day) according to the recommendations found in the NCCLS, EP5-A protocol.
| | Mean value mg/dL | CV % |
| --- | --- | --- |
| Normal control | 98.18 | 2.00 |
| Pathological control | 252.88 | 1.19 |
| Specimen 1 | 99.86 | 2.03 |
| Specimen 2 | 273.38 | 1.48 |
**ABX PENTRA Glucose PAP CP**
**Repeatability (within-run precision)**
| | Mean value mg/dL | CV % |
| --- | --- | --- |
| Normal control | 89.36 | 0.41 |
| Pathological control | 230.53 | 0.40 |
| Specimen 1 | 42.76 | 0.62 |
| Specimen 2 | 111.47 | 0.30 |
| Specimen 3 | 296.22 | 0.49 |
**Reproducibility (total precision)**
| | Mean value mg/dL | CV % |
| --- | --- | --- |
| Normal control | 90.20 | 1.23 |
| Pathological control | 235.44 | 1.12 |
| Specimen 1 | 107.18 | 1.44 |
| Specimen 2 | 298.97 | 1.05 |
**ABX PENTRA Sodium - E**
**Repeatability (within-run precision)**
Two control levels were tested in 2 runs, 20 times per run
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Normal control | 136.04 | 0.17 |
| | 137.74 | 0.24 |
| Pathological control | 159.81 | 0.44 |
| | 159.81 | 0.27 |
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2 serum specimens are tested 10 times
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Serum specimen 1 | 146.45 | 0.12 |
| Serum specimen 2 | 151.21 | 0.09 |
2 plasma specimens are tested 10 times
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Plasma specimen 1 | 144.36 | 0.26 |
| Plasma specimen 2 | 143.95 | 0.23 |
2 urine specimens are tested 10 times
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Urine specimen 1 | 95.61 | 1.09 |
| Urine specimen 2 | 163.17 | 0.79 |
## Reproducibility (total precision)
2 controls are tested in duplicate for 20 days (2 series per day) according to the recommendations found in the NCCLS, EP5-A protocol.
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Normal control | 138.60 | 0.69 |
| Pathological control | 157.58 | 0.92 |
## ABX PENTRA Potassium - E
## Repeatability (within-run precision)
Two control levels were tested in 2 runs, 20 times per run
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Normal control | 3.75 | 0.29 |
| | 3.81 | 0.64 |
| Pathological control | 6.81 | 0.65 |
| | 6.86 | 0.49 |
2 serum specimens are tested 10 times
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Serum specimen 1 | 4.14 | 0.47 |
| Serum specimen 2 | 4.99 | 0.42 |
2 plasma specimens are tested 10 times
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Plasma specimen 1 | 4.35 | 0.46 |
| Plasma specimen 2 | 4.26 | 0.40 |
2 urine specimens are tested 10 times
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Urine specimen 1 | 45.40 | 1.67 |
| Urine specimen 2 | 67.32 | 1.51 |
## Reproducibility (total precision)
2 controls are tested in duplicate for 20 days (2 series per day) according to the recommendations found in the NCCLS, EP5-A protocol
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Normal control | 3.82 | 1.28 |
| Pathological control | 6.76 | 1.56 |
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# ABX PENTRA Chloride – E
## Repeatability (within-run precision)
Two control levels were tested in 2 runs, 20 times per run
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Normal control | 89.25 | 0.26 |
| | 91.04 | 0.32 |
| Pathological control | 119.81 | 0.40 |
| | 117.56 | 0.51 |
2 serum specimens are tested 10 times
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Serum specimen 1 | 108.94 | 0.30 |
| Serum specimen 2 | 116.70 | 0.23 |
2 plasma specimens are tested 10 times
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Plasma specimen 1 | 111.71 | 0.38 |
| Plasma specimen 2 | 110.43 | 0.36 |
2 urine specimens are tested 10 times
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Urine specimen 1 | 104.66 | 2.12 |
| Urine specimen 2 | 154.34 | 2.08 |
## Reproducibility (total precision)
2 controls are tested in duplicate for 20 days (2 series per day) according to the recommendations found in the NCCLS, EP5-A protocol.
| | Mean value mmol/l | CV % |
| --- | --- | --- |
| Normal control | 89.98 | 1.21 |
| Pathological control | 121.99 | 1.12 |
## b. Linearity/assay reportable range:
The reagent linearity is determined according to the recommendations found in the NCCLS, EP6-A protocol.
### ABX PENTRA Glucose HK CP
Low linearity: 1.98 mg/dL
High linearity: 900 mg/dL, with automatic post-dilution: 2700 mg/dL.
### ABX PENTRA Glucose PAP CP
Low linearity: 1.80 mg/dL
High linearity: 432 mg/dL, with automatic post-dilution: 1296 mg/dL.
### ABX PENTRA Sodium – E
| Serum / Plasma: | Low linearity: | 110 mmol/l |
| --- | --- | --- |
| | High linearity: | 200 mmol/l |
| Urine: | Low linearity: | 80 mmol/l |
| | High linearity: | 300 mmol/l |
### ABX PENTRA Potassium – E
| Serum / Plasma: | Low linearity: | 1.4 mmol/l |
| --- | --- | --- |
| | High linearity: | 10 mmol/l |
| Urine: | Low linearity: | 2 mmol/l |
| | High linearity: | 150 mmol/l |
### ABX PENTRA Chloride – E
| Serum / Plasma: | Low linearity: | 85 mmol/l |
| --- | --- | --- |
| | High linearity: | 200 mmol/l |
| Urine: | Low linearity: | 70 mmol/l |
| | High linearity: | 300 mmol/l |
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c. Traceability, Stability, Expected values (controls, calibrators, or methods): Subject of K801297 and K041227 for the ABX PENTRA Multical and ABX PENTRA N & P Controls.
ABX PENTRA Standard 1, Standard 2 and Reference solutions are made from weighed raw materials, so that electrolyte concentrations remain the same from lot to lot:
ABX Pentra Standard 1 and Standard 2 component concentrations:
| | ABX Pentra Standard 1 | ABX Pentra Standard 2 |
| --- | --- | --- |
| Na+ | 120 mmol/l | 200 mmol/l |
| K+ | 4 mmol/l | 7 mmol/l |
| Cl- | 100 mmol/l | 150 mmol/l |
ABX Pentra Reference component concentration:
| | ABX Pentra Reference |
| --- | --- |
| KCl | 1.5 mol/l |
Pentra 400 ISE module calibration stabilities and control values have been tested during the ABX Pentra 400 Standard 1, Standard 2 and Reference reagent life time. Its closed stability is validated on 18 months, its on board stability is validated on 1 month.
d. Detection limit:
ABX PENTRA Glucose HK CP
1.98 mg/dL
ABX PENTRA Glucose PAP CP
1.80 mg/dL
ABX PENTRA ISE
Not Applicable
e. Analytical specificity:
ABX PENTRA Glucose HK CP
Haemoglobin: No significant influence is observed up to 500 mg/dL
Triglycerides: No significant influence is observed up to 613 mg/dL (as Intralipid®, representative of lipemia)
Total Bilirubin: No significant influence is observed up to 36 mg/dL
Direct Bilirubin: No significant influence is observed up to 36 mg/dL
ABX PENTRA Glucose PAP CP
Haemoglobin: No significant influence is observed up to 460 mg/dL
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Triglycerides: No significant influence is observed up to 613 mg/dL (as Intralipid®, representative of lipemia)
Total Bilirubin: No significant influence is observed up to 8.19 mg/dL
Direct Bilirubin: No significant influence is observed up to 5.63 mg/dL
ABX PENTRA Sodium – E
Haemoglobin: No significant influence is observed up to 10 g/l
Triglycerides: No significant influence
Total Bilirubin: No significant influence
Direct Bilirubin: No significant influence
ABX PENTRA Potassium - E
Haemoglobin: No significant influence is observed up to 1 g/l
Triglycerides: No significant influence
Total Bilirubin: No significant influence
Direct Bilirubin: No significant influence
ABX PENTRA Chloride – E
Haemoglobin: No significant influence is observed up to 10 g/l
Triglycerides: No significant influence
Total Bilirubin: No significant influence
Direct Bilirubin: No significant influence
Drugs: Acetylsalicylic acid and probenecid acid falsely increase chloride concentrations. 2.6 mmol/l acetylsalicylic acid concentration falsely increases the chloride concentration of around 10%.
f. Assay cut-off:
Not Applicable
2. Comparison studies:
a. Method comparison with predicate device:
ABX PENTRA Glucose HK CP
103 patient samples are correlated with a commercial reagent taken as reference according to the recommendations found in the NCCLS, EP9-A2 protocol.
The equation for the allometric line obtained is (in mg/dL):
$$Y = 0.93x + 2.70$$ with a correlation coefficient $$r^2 = 0.9958$$.
ABX PENTRA Glucose PAP CP
103 patient samples are correlated with a commercial reagent taken as reference according to the recommendations found in the NCCLS, EP9-A2 protocol.
The equation for the allometric line obtained is:
$$Y = 0.98x + 0.72$$ with a correlation coefficient $$r^2 = 0.9974$$.
ABX PENTRA Sodium – E
The equation for the allometric line obtained on serum (N=100) is:
$$Y = 0.98x + 2.64$$ with a correlation coefficient $$r^2 = 0.9991$$.
The equation for the allometric line obtained on plasma (N=100) is:
$$Y = 0.97x + 4.77$$ with a correlation coefficient $$r^2 = 0.9960$$.
The equation for the allometric line obtained on urine (N=103) is:
$$Y = 1.00x + 1.00$$ with a correlation coefficient $$r^2 = 0.9851$$.
ABX PENTRA Potassium - E
The equation for the allometric line obtained on serum (N=100) is:
$$Y = 1.00x + 0.00$$ with a correlation coefficient $$r^2 = 0.9988$$.
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The equation for the allometric line obtained on plasma (N=100) is:
$$
Y = 1.00 x + 0.00 \text{ with a correlation coefficient } r2 = 0.9977.
$$
The equation for the allometric line obtained on urine (N=103) is:
$$
Y = 1.03 x - 0.72 \text{ with a correlation coefficient } r2 = 0.9753.
$$
ABX PENTRA Chloride – E
The equation for the allometric line obtained on serum and plasma (N=152) is:
$$
Y = 1.09 x - 10.60 \text{ with a correlation coefficient } r2 = 0.9651.
$$
The equation for the allometric line obtained on urine (N=103) is:
$$
Y = 0.99 x + 2.64 \text{ with a correlation coefficient } r2 = 0.9730.
$$
b. Matrix comparison:
ABX PENTRA Glucose HK CP
Slope = 1.02 intercept = -2.55 r2 = 0.988, N=42 on serum verses plasma Heparin-Lithium
ABX PENTRA Glucose PAP CP
Slope = 1.01 intercept = -2.11 r2 = 0.990, N=43 on serum verses plasma Heparin-Lithium
See method comparison for I.S.E.
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:
Literature reference
N. Instrument Name:
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
O. System Descriptions:
1. Modes of Operation:
Routine or Stat random access
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐
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3. Specimen Identification:
Real patient sample bar-code ID
4. Specimen Sampling and Handling:
Primary tubes or sample cups
5. Calibration:
Calibration modes: Factor, Slope average, Linear regression, Linear interpolation, LOGIT/LOG4, LOGIT/LOG5, EXPONENT5
6. Quality Control:
The Quality Control allows the user to check the quality of measurements performed by the instrument. Statistical analyses of the control results are performed. These statistical analyses consist in calculating the average, the standard deviation and the coefficient of variation of the measurement over a defined period. They can be carried out over the following periods:
- the current Worklist
- a specific month
- a specific year.
The Quality Control is done by reviewing either the results and statistical analyses of a selected control for each test controlled with this control or the results and statistical analyses of all controls used for a selected test.
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
None
Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
