ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
Device Facts
| Record ID | K123171 |
|---|---|
| Device Name | ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT |
| Applicant | HORIBA ABX SAS |
| Product Code | CJY · Clinical Chemistry |
| Decision Date | Jul 3, 2013 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 862.1145 |
| Device Class | Class 2 |
Indications for Use
ABX Pentra Calcium AS CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on a colourimetric method, using the ABX Pentra 400 Clinical Chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical clinical chemistry analyzers. The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers. The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
Device Story
ABX Pentra Calcium AS CP is an in vitro diagnostic reagent for quantitative calcium measurement in human serum, plasma, and urine. Used on the ABX PENTRA 400 clinical chemistry analyzer, the device employs a colorimetric method where calcium ions react with Arsenazo III to form a purple complex. Absorbance is measured bichromatically at 660/700 nm; the increase in absorbance is directly proportional to calcium concentration. The system includes a mono-reagent cassette, lyophilized human serum calibrator (Multical), and quality controls (N Control, P Control, and Urine Control L/H). The device is operated by laboratory personnel in a clinical setting. Output is a quantitative calcium concentration value, which healthcare providers use to diagnose and monitor parathyroid, bone, and renal diseases, as well as tetany. The system provides automated post-dilution for samples exceeding the measuring range.
Clinical Evidence
No clinical studies were performed. Analytical performance was established via bench testing. Precision studies (n=80 per level) showed total CVs between 1.44% and 1.57%. Linearity was confirmed for serum (3.39-21.0 mg/dL) and urine (0.33-18.9 mg/dL). Method comparison against the predicate (n=145 serum, n=143 urine) yielded r² values of 0.9902 and 0.9930, respectively. Interference testing confirmed non-significant bias for common endogenous and exogenous substances.
Technological Characteristics
Colorimetric assay using Arsenazo III. Reagent is a chemical solution in a mono-reagent cassette. Calibrators and controls are lyophilized human serum or liquid human urine with chemical/biological additives. Operates on the ABX PENTRA 400 discrete photometric benchtop clinical chemistry analyzer. Calibration is lot-specific. Reagent stability: 24 months closed, 60 days on-board.
Indications for Use
Indicated for quantitative in vitro determination of calcium in human serum, plasma, and urine to aid in the diagnosis and treatment of parathyroid disease, bone diseases, chronic renal disease, and tetany. For prescription use on the ABX Pentra 400 Clinical Chemistry analyzer.
Regulatory Classification
Identification
A calcium test system is a device intended to measure the total calcium level in serum. 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).
Predicate Devices
- Olympus Calcium Arsenazo reagent (K061575)
- ABX Pentra Multical (K052007)
- ABX Pentra N Control (K052007)
- ABX Pentra P Control (K052007)
- ABX Pentra Urine Control L/H (K070249)
Related Devices
- K981794 — HICHEM CALCIUM REAGENT KIT · Hichem Diagnostics · Jul 29, 1998
- K021334 — WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 · Wiener Laboratories Saic · Sep 10, 2002
- K182042 — Randox Calcium (Ca) · Randox Laboratories, Ltd. · Oct 23, 2018
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k123171
B. Purpose for Submission:
New device
C. Measurand:
Calcium
D. Type of Test:
Quantitative, colorimetric method
E. Applicant:
HORIBA ABX S.A.S
F. Proprietary and Established Names:
1. ABX Pentra Calcium AS CP
2. ABX Pentra Multical
3. ABX Pentra N Control
4. ABX Pentra P Control
5. ABX Pentra Urine Control L/H
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CJY | II | §862.1145 calcium test system | 75-Chemistry |
| JIX | II | §862.1150 calibrator | 75-Chemistry |
| JJY | I, reserved | §862.1660 quality control material (assayed) | 75-Chemistry |
H. Intended Use:
1. Intended use(s):
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See Indications for use in (2) below.
2. **Indication(s) for use:**
ABX Pentra Calcium AS CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on a colourimetric method, using the ABX Pentra 400 Clinical Chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
3. **Special conditions for use statement(s):**
The device is for prescription use.
4. **Special instrument requirements:**
For use with ABX Pentra 400 Clinical Chemistry Analyzer
I. **Device Description:**
The ABX Pentra Calcium AS CP is an in vitro diagnostic assay for the quantitative in vitro determination of calcium in human serum, plasma and urine based on colorimetric method. It is composed of a mono-reagent cassette (79 mL). The reagent is a chemical solution with additives, including 100 mmol/L of MES pH 6.50, and 200 μmol/L of Arsenazo III.
The ABX Pentra Multical is a single level, lyophilized human serum calibrator with chemical additives and materials of biological origin (extracts from human or animal derived tissue). The assigned values of the calibrator components are given in the
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product labeling, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX Pentra 400 analyzer. This calibrator is provided in ten vials of lyophilized material sufficient to produce 3 ml when re-suspended in distilled or deionized water.
The ABX Pentra N Control and ABX Pentra P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin (extracts from human or animal derived tissue) added as required to obtain given component levels. The assigned values of the control components are given in the product labeling, and reflect normal (N Control) and pathological (P control) calcium levels, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX Pentra 400 analyzer. Each control is provided in ten vials of lyophilized material sufficient to produce 5 ml when re-suspended in distilled or deionized water.
The ABX Pentra Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin (human and animal origin) added as required to obtain given component levels, including preservatives and stabilizers. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX Pentra 400 analyzer. Each control level is provided in one vial of 10 ml, liquid, ready to use.
The sponsor stated in the labeling that each donor unit used in the preparation of the calibrator and controls were tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HbsAg), antibodies to Hepatitis C (HCV) and antibodies to HIV-I/HIV-2.
J. Substantial Equivalence Information:
1. Predicate device name(s) and 510(k) numbers:
Beckman Olympus Calcium Arsenazo reagent: k061575
Horiba ABX Pentra MULTICAL: k052007
Horiba ABX Pentra N and P Controls: k052007
Horiba ABX Pentra Urine Controls L/H: k070249
2. Device comparison with predicate:
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| 1. Similarities and Differences for ABX Pentra Calcium AS CP | | |
| --- | --- | --- |
| Item | Candidate Device: ABX Pentra Calcium AS CP (Candidate Device) | Predicate Device: Olympus Calcium Arsenazo Reagent (k061575) |
| Intended Use/Indications for Use | Same | Reagent for the quantitative determination of calcium in human serum, plasma and urine on automated clinical chemistry analyzers.
Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). |
| Specimen Type | Same | Serum, Plasma, and Urine |
| Instrument | ABX Pentra 400 | Beckman Coulter Clinical Chemistry Analyzers |
| Method | Same | Colorimetric, quantitative |
| Expected values | Serum/Plasma: 8.6 -10.3 mg/dL
Urine-Male: <300 mg/24 hr
Urine-Female: <250 mg/24 hr | Serum/Plasma (Adults): 8.8 -10.6 mg/dL
Serum (Children 0 – 10 day): 7.6 – 10.4 mg/dL
Serum (Children 2 – 12 year): 8.8 – 10.8 mg/dL
Urine-Male: <300 mg/24 hr
Urine-Female: <250 mg/24 hr |
| Measuring range | Serum/Plasma: 4 – 18 mg/dL
Urine: 0.64 – 18 mg/dL | Serum/Plasma: 4 - 18 mg/dL
Urine: 0.1 - 40 mg/dL |
| Reagent Configuration | Same | Single part liquid |
| Reagent Stability | Unopened: 2-8°C until expiration date
On board stability: 60 days | Unopened: 2-8°C until expiration date
On board stability: 90 days |
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| 2. Similarities and Differences for ABX Pentra Multical | | |
| --- | --- | --- |
| Item | ABX Pentra Multical (Candidate Device) | ABX Pentra Multical (k052007) |
| Intended Use | Same | The ABX Pentra Multical is a calibrator for use in the calibration of specified quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers. |
| Constituents | Same, with addition of Calcium | Multi-analyte calibrator |
| Matrix | Same | Lyophilized human serum with chemical additives |
| 3. Similarities and Differences for ABX Pentra N and P Controls | | |
| --- | --- | --- |
| Item | ABX Pentra N and P Controls (Candidate Device) | ABX Pentra N and P Controls (k052007) |
| Intended Use | Same | For use in quality control by monitoring accuracy and precision. |
| Constituents | Same, with addition of Calcium | Multi-analyte control material |
| Matrix | Same | Lyophilized human serum with chemical additives |
4. Comparison of new device (ABX Pentra Urine Controls L/H) with the predicate device (ABX Pentra Urine Controls L/H previously cleared in k070249):
| Similarities and Differences for ABX Pentra L/H Urine Controls | | |
| --- | --- | --- |
| Item | ABX Pentra L/H Urine Controls (Candidate Device) | ABX Pentra L/H Urine Controls (k070249) |
| Intended Use | Same | For use in quality control by monitoring accuracy and precision. |
| Constituents | Same, with addition of Calcium | Multi-analyte control material |
| Matrix | Same | Human urine with chemical additives |
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K. Standard/Guidance Document Referenced (if applicable):
CLSI, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline –Second Edition (EP05-A2)
CLSI, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition (Interim Revision) (EP09-A2-IR)
CLSI, Protocols for Determination of Limits of Detection and Limits of Quantitation (EP17-A)
CLSI, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (EP6-A)
L. Test Principle:
Calcium ions (Ca²⁺) react with Arsenazo III (2,2’-[1,8-Dihydroxy-3,6-disulphonaphthylene-2,7-bisazo]-bisbenzenearsonic acid) to form an intense purple colored complex. The absorbance of the Ca-Arsenazo III complex is measured bichromatically at 660/700 nm. The resulting increase in absorbance of the reaction mixture is directly proportional to the calcium concentration in the sample.
M. Performance Characteristics:
1. Analytical performance:
a. Precision/Reproducibility:
Precision studies for serum samples were conducted on the ABX Pentra 400 following CLSI guidance document EP05-A2. Two levels of control serum and 3 serum-based samples were run 2 times per run, 2 runs per day, for a total of 20 days (n = 80 measurements/sample level). Results are summarized below for within-run and total precision.
| | | Within Run | | Total | |
| --- | --- | --- | --- | --- | --- |
| | Mean (mg/dL) | Std Dev | %CV | Std Dev | %CV |
| N Control | 8.72 | 0.04 | 0.44 | 0.13 | 1.44 |
| P Control | 13.0 | 0.06 | 0.46 | 0.19 | 1.49 |
| Sample 1 | 7.03 | 0.03 | 0.38 | 0.11 | 1.56 |
| Sample 2 | 9.47 | 0.03 | 0.31 | 0.15 | 1.54 |
| Sample 3 | 12.9 | 0.04 | 0.30 | 0.20 | 1.54 |
Precision studies for urine samples were conducted on the ABX Pentra 400 following CLSI guidance document EP05-A2. Two levels of urine controls
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(Level L and Level H) and 3 urine samples were run 2 times per run, 2 runs per day, for a total of 20 days ( $n = 80$ measurements/sample level). Results are summarized below for within-run and total precision.
| | | Within Run | | Total | |
| --- | --- | --- | --- | --- | --- |
| | Mean (mg/dL) | Std Dev | %CV | Std Dev | %CV |
| Level L | 7.28 | 0.07 | 0.93 | 0.11 | 1.45 |
| Level H | 10.7 | 0.07 | 0.64 | 0.16 | 1.50 |
| Sample 1 | 7.70 | 0.03 | 0.40 | 0.12 | 1.57 |
| Sample 2 | 10.3 | 0.04 | 0.43 | 0.16 | 1.57 |
| Sample 3 | 14.2 | 0.05 | 0.35 | 0.22 | 1.56 |
# b. Linearity/assay reportable range:
A serum sample linearity study was performed according to CLSI guidance document EP6-A recommendations. A series of 10 samples was prepared by combining various volumetric proportions of a high concentration calcium human serum pool with a low concentration calcium sample to produce samples with calcium values ranging from 3.39 to $21.0\mathrm{mg / dL}$ . Each level was measured in quadruplicate using 1 instrument and 1 lot of reagent. Linear regression analysis of a plot of expected values and experimentally determined values produced a curve fit with the following equation: $\mathrm{y} = 1.01\mathrm{x} - 0.24$ , $\mathrm{R}^2 = 0.9994$ .
A urine sample linearity study was performed according to CLSI guidance document EP6-A recommendations. A series of 12 samples was prepared by combining various volumetric proportions of a high concentration urine pool with saline to produce samples with calcium values ranging from 0.33 to $18.9\mathrm{mg / dL}$ . Each level was measured in quadruplicate using 1 instrument and 1 lot of reagent. Linear regression analysis of a plot of expected values and experimentally determined values produced a curve fit with the following equation: $\mathrm{y} = 0.933\mathrm{x} - 0.345$ , $\mathrm{R}^2 = 0.9996$ .
The linearity studies provided by the sponsor support reportable range claims for the ABX Pentra Calcium AS CP device of 4 - 18.05 mg/dL calcium for serum samples, and 0.64 - 18.05 mg/dL calcium for urine samples.
# Automatic Dilution
The Pentra 400 performs automatic dilutions (1:3) on calcium samples if the value is $>18.05\mathrm{mg / dL}$ . A study was performed comparing manual dilutions to the Pentra 400 automated dilutions of 7 pooled serum samples and 7 pooled urine samples spiked with calcium. Samples ranged from $18.4\mathrm{mg / dL}$ to 54.15 $\mathrm{mg / dL}$ , and were measured in duplicate. Manual and automated dilution
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factors were the same and each sample was run in duplicate. All results are within +/- 10% recovery. These studies support the sponsor's claim that urine and serum/plasma samples with calcium concentrations up to 54.15 mg/dL can be run on the Pentra 400 system.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
**Traceability:**
The calibrators and controls used in this submission are previously cleared in k052007 for ABX Pentra Multical, ABX Pentra N Control and ABX Pentra P Control and in k070249 for ABX Pentra Urine Control L/H. The calcium material introduced into the calibrators and its corresponding value is traceable to NIST reference material SRM909b. In this submission, calcium values for this assay are being added to the existing calibrator and control materials.
**Stability:**
Real-time testing was conducted. The stability study protocol and the acceptance criteria have been reviewed and found to be acceptable. The study results support the following stability claims in the labeling:
| Item | Storage Conditions | | Claimed Stability |
| --- | --- | --- | --- |
| Calibrators | Close-Vial | 2-8°C | 24 months |
| | Open-Vial | -25 °C to -15°C | 2 weeks |
| | | 2-8°C | 2 days |
| | | 15°C to 25°C | 8 hours |
| Serum controls | Close-Vial | 2-8°C | 30 months |
| | Open-Vial | -25 °C to -15°C | 1 month |
| | | 2-8°C | 5 days |
| | | 15°C to 25°C | 12 hours |
| Urine controls | Close-Vial | 2-8°C | 2 years |
| | Open-Vial | 2-8°C | 30 days |
**Value assignment:**
Controls: The target value is determined by the median of 150 results from 6 ABX Pentra 400 analyzers. The lot specific control range is calculated as the target value ± 3 SD. The following is an example of the nominal calcium values which are expected for the ABX Pentra 400 analyzer:
N Control: 8.50 mg/dL
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P Control: 13.4 mg/dL
Urine control L: 71.4 mg/dL
Urine control H: 99.4 mg/dL
Calibrator: The target value is determined by the median of 150 results from 6 ABX PENTRA 400 analyzers. The nominal calcium value expected for the ABX Pentra 400 analyzer is 10.55 mg/dL.
## Calibration Interval:
ABX Pentra Calcium AS CP assay calibration stability was assessed, and the sponsor claims that calibration is stable for 10 days. The protocol and acceptance criteria have been provided and found to be adequate to support the sponsor's claims. The sponsor also recommends using quality control samples at least once a day, after each calibration.
## d. Detection limit:
The sponsor performed a detection limit study for the ABX Pentra Calcium AS CP assay on the ABX Pentra 400 instrument system, following CLSI guidance document EP17-A.
Limit of Blank (LoB) was determined by assaying 30 replicate measurements of a blank sample, performed on each of 3 ABX Pentra 400 instruments over 2 days (N = 180). The LoB was calculated as 0.20 mg/dL.
Limit of Detection (LoD) was determined in serum and urine by assaying 20 replicate measurements of 4 serum and 4 urine samples, respectively, with concentrations ranging between LoB and LoB x 4. The LoDs for serum and urine were calculated as 0.28 mg/dL and 0.23 mg/dL, respectively.
Limit of Quantitation (LoQ) was determined by assaying 10 replicate measurements of 10 low calcium concentration samples for both serum and urine, over 3 days. The LoQ was based on inter-assay precision less than 10% CV. The LoQ in serum and urine were determined as 1.54 mg/dL and 0.64 mg/dL, respectively.
The ABX Pentra Calcium assay has a measuring range of 4 - 18.05 mg/dL for serum sample, and 0.64 - 18.05 mg/dL for urine sample.
## e. Analytical specificity:
Interference studies were performed to determine the effects from potential interferents on the ABX PENTRA Calcium AS CP assay. Various concentrations of interferents were spiked into pooled human serum or pooled human urine containing calcium at low (~8.5 mg/dL) and elevated (~15
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mg/dL) concentrations. All samples were tested in quadruplicate. Non-significant interference was defined by the sponsor as the highest interferent level tested with bias ≤5% of the control for serum samples or ≤10% of the control for urine samples. Below is a summary table of the highest concentration of interferent tested and found not to interfere based on the stated acceptance criteria.
| Test Interferent | Concentration | |
| --- | --- | --- |
| | Serum | Urine |
| Magnesium | 10.7 mg/dL | 13.0 mg/dL |
| Ascorbic Acid (L) | 60.0 mg/dL | 60.0 mg/dL |
| Total Bilirubin | 46.1 mg/dL | N/A |
| Direct Bilirubin | 26.0 mg/dL | 25.3 mg/dL |
| Intralipid (Turbidity) | 500 mg/dL | 613 mg/dL |
| Hemoglobin | 500 mg/dL | 500 mg/dL |
| Ibuprofen | 50.1 mg/dL | N/A |
| Acetaminophen | 20.0 mg/dL | N/A |
| Acetylsalicylic acid | 65.2 mg/dL | N/A |
In addition, the effect of acidification or alkalinization of urine samples on calcium concentration was evaluated. Two urine samples with different calcium concentrations were either acidified (to pH 1.7) or alkalinized (to pH 11.5), and were run in triplicate. In comparison to untreated urine samples no interference was observed for acidification, while significant interference was observed for urine samples with pH greater than pH 7.0.
Since alkaline pH affects the urine calcium results, the sponsor includes the following limitation in their labeling:
"24 hours urine specimens have to be collected with HCl 6N. Non acidified urines which have been refrigerated should be acidified and/or heated at 56°C for 15 minutes to re-dissolve any precipitate."
f. Assay cut-off:
Not Applicable
2. Comparison studies:
a. Method comparison with predicate device:
Serum:
A method comparison study was performed to assess the performance of the ABX Pentra Calcium AS CP assay with the Olympus Calcium Arsenazo Reagent (predicate device) following CLSI guidance document EP9-A2. 145
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human serum samples, 16 of which were altered, were assayed using the subject and predicate methods. Samples were measured in singlicate and ranged in calcium concentration from 4.17 to 15.9 mg/dL. Linear regression analysis, resulting from a plot of calcium concentrations obtained on the subject (Y-axis) and predicate (X-axis) devices, resulted in the following line fit equation: y = 1.007x + 0.028, r² = 0.9902.
**Urine:**
A method comparison study was performed to assess the performance of the ABX Pentra Calcium AS CP assay with the Olympus calcium arsenazo reagent (predicate device), following CLSI guidance document EP9-A2. 143 human urine samples using the subject and predicate methods were analyzed. Samples were measured in singlicate and ranged in calcium concentration from 0.64 to 17.8 mg/dL. Linear regression analysis, resulting from a plot of calcium concentrations obtained on the subject (Y-axis) and predicate (X-axis) devices, resulted in the following line fit equation: y = 0.977x + 0.097, r² = 0.9930.
**b. Matrix comparison:**
The sponsor performed a matrix comparison study to compare the performance between serum and lithium-heparin plasma samples. The study included 32 paired serum and plasma samples (Lithium-Heparin Plasma) ranging in calcium concentration from 4.0 mg/dL to 17.5 mg/dL; 3 samples were altered. Each sample was tested in singlicate using the ABX Pentra Calcium AS CP assay reagent. Linear regression analysis of the plot of serum (x-axis) and plasma (y-axis) samples showed the following relationships between the matrix types:
$$
y = 1.006x - 0.0022, r^2 = 0.996
$$
The sponsor concluded that Li-Heparin plasma is an acceptable anti-coagulant to be used with the ABX Pentra Calcium AS CP assay.
**3. Clinical studies:**
**a. Clinical Sensitivity:**
Not Applicable
**b. Clinical specificity:**
Not Applicable
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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:
Reference ranges are provided in the labeling from published literature as follows (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):
Serum plasma: 8.6 – 10.3 mg/dL
Urine-male: <250 mg/24 h
Urine-Female: <300 mg/24 h
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.
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