CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV

K192730 · Biosystems S.A. · CHW · Sep 9, 2020 · Clinical Chemistry

Device Facts

• Record ID: K192730
• Device Name: CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
• Applicant: Biosystems S.A.
• Product Code: CHW · Clinical Chemistry
• Decision Date: Sep 9, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Indications for Use

CALCIUM-CRESOLPHTHALEIN: Reagent for the measurement of calcium concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. GLUCOSE: Reagent for the measurement of glucose concentration in human serum and plasma. The obtained values are useful as an aid in the diagnosis and treatment of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. UREA/BUN - UV: Reagent for the measurement of urea concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of certain renal and metabolic diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

Device Story

Quantitative photometric assays for calcium, glucose, and urea/BUN; reagents provided ready-to-use for BioSystems BA400 analyzers. Calcium measured via o-cresolphthalein complexone reaction; glucose via glucose oxidase/peroxidase reaction; urea via urease/glutamate dehydrogenase reaction. Analyzers perform spectrophotometric measurement of colored complexes. Used in clinical laboratories by trained personnel. Output provides analyte concentration values; assists clinicians in diagnosing/monitoring metabolic, renal, and endocrine conditions. No wireless or external data transmission capabilities.

Clinical Evidence

Bench testing only. Precision studies (n=80 per level) showed CVs ranging from 0.2% to 5.0%. Linearity (r² ≥ 0.999) and detection limits (LoB, LoD, LoQ) were established per CLSI guidelines. Method comparison against predicate devices (n=77-153 samples) showed high correlation (R ≥ 0.992). Interference testing confirmed performance within 10% threshold for common endogenous and exogenous substances.

Technological Characteristics

Photometric assays; reagents include enzymes (glucose oxidase, peroxidase, urease, glutamate dehydrogenase) and chemical complexes (o-cresolphthalein). Dimensions/form factor: ready-to-use liquid reagents. Energy source: spectrophotometric light source in BA400 analyzer. Connectivity: standalone, no wireless/network transmission. Sterilization: not applicable (reagents).

Indications for Use

Indicated for measurement of calcium, glucose, and urea/BUN in human serum, plasma, or urine to aid in diagnosis/treatment of parathyroid, bone, renal, metabolic diseases, tetany, and diabetes mellitus. For professional in vitro clinical laboratory use only.

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).

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K192730

B Applicant

BioSystems S.A.

C Proprietary and Established Names

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CHW | Class II | 21 CFR 862.1145 - Calcium Test System | CH - Clinical Chemistry |
| CGA | Class II | 21 CFR 862.1345 - Glucose test system | CH - Clinical Chemistry |
| CDQ | Class II | 21 CFR 862.1770 - Urea nitrogen test system | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:

New device

B Measurand:

Calcium, Glucose and Urea/BUN (blood urea nitrogen)

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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C Type of Test:

Calcium, Glucose and Urea/BUN are quantitative photometric assays.

III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

CALCIUM-CRESOLPHTHALEIN: Reagent for the measurement of calcium concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

GLUCOSE: Reagent for the measurement of glucose concentration in human serum and plasma. The obtained values are useful as an aid in the diagnosis and treatment of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

UREA/BUN - UV: Reagent for the measurement of urea concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of certain renal and metabolic diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

D Special Instrument Requirements:

BioSystems BA400

IV Device/System Characteristics:

A Device Description:

Reagents are provided ready to use.

CALCIUM-CRESOLPHTHALEIN: Reagent for the measurement of calcium concentration in human serum, plasma or urine. The CALCIUM-CRESOLPHTHALEIN assay consists of the following reagents:

- Ethanolamine 900 mmol/L.

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- Reagent: O-Cresolphthalein Complexone 0.3 mmol/L, 8 hydroxyquinoline 28 mmol/L, hydrochloric acid 100 mmol/L.

The GLUCOSE assay consists of the following reagents:
Phosphate 100 mmol/L, phenol 5 mmol/L, glucose oxidase > 10 U/mL, peroxidase >1 U/mL, 4-aminoantipyrine 0.4 mmol/L, pH 7.5

The UREA/BUN - UV assay consists of the following reagents:
- Tris 100 mmol/L, 2-oxoglutarate 5.6 mmol/L, urease > 140 U/mL, glutamate dehydrogenase > 140 U/mL, ethyleneglicol 220 g/L, sodium azide 0.95, pH 8.0.
- NADH 1.5 mmol/L, sodium azide 9.5 g/L.

## B Principle of Operation:

The CALCIUM-CRESOLPHTHALEIN reagent is a photometric assay in which Calcium in the sample reacts with o-cresolphthalein complexone (o-CPC) forming a colored complex that can be measured by spectrophotometry.

The GLUCOSE reagent is a photometric assay in which glucose is oxidized by glucose-oxidase to gluconate and hydrogen peroxide. The hydrogen peroxide is then oxidized by peroxidase in the presence of 4-aminoantipyrine and phenol to form a colored complex that can be measured by spectrophotometry.

The UREA-BUN/UV reagent is a photometric assay in which BUN-Urea is hydrolyzed by urease to produce ammonia and carbon dioxide. The ammonia reacts with 2-oxoglutarate in the presence of NADH to yield glutamate and NAD+.

| Modes of Operation | Yes | No |
| --- | --- | --- |
| Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? | ☐ | ☑ |
| Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? | ☐ | ☑ |
| Software | | |
| FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types. | ☐ | ☑ |

## V Substantial Equivalence Information:

A Predicate Device Name(s):
CALCIUM GEN. 2
GLUCOSE HK GEN. 3
Urea/BUN

B Predicate 510(k) Number(s):
K100853

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Comparison with Predicate(s):

| Device & Predicate Device(s): | K192730 | K100853 |
| --- | --- | --- |
| Device Trade Name | CALCIUM-CRESOLPHTHALEIN | CALCIUM GEN. 2 |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Reagent for the measurement of calcium concentration | Same |
| Measurand | Calcium | Same |
| Sample type | Serum, Lithium Heparin plasma or urine. | Same |
| General Device Characteristic Differences | | |
| Method | O-CRESOLPHTHALEIN COMPLEXONE | NM-BAPTA |
| Measuring range | Serum/plasma: 0.80 - 20 mg/dL
Urine: 3.97-30 mg/dL | Serum/plasma: 0.80 - 20.1 mg/dL
Urine: 0-140 mg/dL |
| Device & Predicate Device(s): | K192730 | K100853 |
| --- | --- | --- |
| Device Trade Name | GLUCOSE | GLUCOSE HK GEN. 3 |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Reagent for the measurement of glucose concentration | Same |
| Measurand | Glucose | Same |
| General Device Characteristic Differences | | |
| Method | Oxidase | Hexokinase |
| Sample type | Serum or Lithium Heparin plasma | Serum, plasma, urine or cerebrospinal fluid |

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| Device & Predicate Device(s): | K192730 | K100853 |
| --- | --- | --- |
| Measuring range | Serum/plasma: 2.0 - 500 mg/dL | Serum/plasma: 2.0 - 750 mg/dL |
| Device & Predicate Device(s): | K192730 | K100853 |
| --- | --- | --- |
| Device Trade Name | UREA-BUN/UV | Urea/BUN |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Reagent for the measurement of urea concentration | Same |
| Measurand | Urea | Same |
| Sample type | Serum, Lithium Heparin plasma or urine. | Same |
| Method | Urease/Glutamate Dehydrogenase | Same |
| General Device Characteristic Differences | | |
| Measuring range | Serum/plasma: 10 mg/dL–240 mg/dL
Urine: 635-12000 mg/dL | Serum/plasma: 3.0-240 mg/dL
Urine: 6-12000 mg/dL |

VI Standards/Guidance Documents Referenced:

CLSI - EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Third Edition.

CLSI - EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.

CLSI - EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Internal precision studies were performed according to the CLSI EP5-A3 guideline. For CALCIUM-CRESOLPHTHALEIN, GLUCOSE and UREA/BUN - UV, three levels of commercial biochemistry control serum (human serum matrix) Level I, II and III or Urine,

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Level I, II and III were tested on two runs per day, two measurements per run, for twenty days with a total of 80 observations using the BioSystems BA400 analyzer. The results of the precision studies are summarized in the tables below:

CALCIUM-CRESOLPHTHALEIN:

| Matrix | Samples | n | Mean (mg/dL) | Repeatability | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | CV% | SD | CV% |
| Serum | Level 1 | 80 | 5.10 | 0.1 | 1.6 | 0.1 | 2.9 |
| | Level 2 | 80 | 10.0 | 0.2 | 2.2 | 0.3 | 2.7 |
| | Level 3 | 80 | 14.0 | 0.1 | 1.0 | 0.3 | 1.9 |
| Urine | Level 1 | 80 | 7.95 | 0.2 | 1.9 | 0.3 | 3.3 |
| | Level 2 | 80 | 15.5 | 0.2 | 1.2 | 0.4 | 2.3 |
| | Level 3 | 80 | 26.6 | 0.3 | 1.0 | 0.9 | 3.5 |

GLUCOSE:

| Matrix | Samples | n | Mean (mg/dL) | Repeatability | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | CV% | SD | CV% |
| Serum | Level 1 | 80 | 48.6 | 0.3 | 0.7 | 0.4 | 0.9 |
| | Level 2 | 80 | 211 | 0.9 | 0.4 | 2.2 | 1.0 |
| | Level 3 | 80 | 389 | 0.9 | 0.2 | 2.4 | 0.6 |

UREA/BUN - UV:

| Matrix | Samples | n | Mean (mg/dL) | Repeatability | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | CV% | SD | CV% |
| Serum | Level 1 | 80 | 26.8 | 1.0 | 3.6 | 1.3 | 5.0 |
| | Level 2 | 80 | 137 | 1.5 | 1.1 | 2.3 | 1.7 |
| | Level 3 | 80 | 172 | 2.2 | 1.3 | 3.4 | 2.0 |
| Urine | Level 1 | 80 | 1003 | 39.5 | 3.9 | 45.5 | 4.5 |
| | Level 2 | 80 | 1918 | 44.6 | 2.3 | 59.5 | 3.1 |
| | Level 3 | 80 | 7293 | 87.3 | 1.2 | 180 | 2.5 |

2. Linearity:

Linearity studies were conducted according to the CLSI EP06-A guideline. Eleven levels of dilutions were prepared by mixing different proportions of samples with high and low concentration of each analyte. Samples were analyzed on one BA400 instrument in duplicate. The results of the regression analysis are shown below:

| Analyte | Matrix | Slope | Intercept | r2 | Range Conc. Tested (mg/dL) | Claimed range (mg/dL) |
| --- | --- | --- | --- | --- | --- | --- |
| CALCIUM-CRESOLPH-THALEIN | Serum | 1.004 | -0.42 | 0.999 | 0.0 – 20.0 | 0.80 - 20.0 |
| | Urine | 1.010 | -0.119 | 1.000 | 0.0 – 30.0 | 3.97 – 30.0 |

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| Analyte | Matrix | Slope | Intercept | r² | Range Conc. Tested (mg/dL) | Claimed range (mg/dL) |
| --- | --- | --- | --- | --- | --- | --- |
| GLUCOSE | Serum | 1.002 | 2.61 | 1.000 | 0.0 - 500 | 2.0 - 500 |
| UREA/BUN - UV | Serum | 1.004 | -0.42 | 0.999 | 0.0 - 240 | 10.0 - 240 |
| | Urine | 0.996 | 0.19 | 0.999 | 0.0 - 12000 | 635 - 12000 |

The linearity studies support the sponsor’s claimed measuring ranges as described in the table above.

## 3. Analytical Specificity/Interference:

Interference studies were performed for CALCIUM-CRESOLPHTHALEIN, GLUCOSE and UREA/BUN – UV. Specimens consisted of human serum and urine representing low and high concentrations of the analyte, with and without the substance tested for interference. Serum samples for the CALCIUM-CRESOLPHTHALEIN assay were tested at concentrations of approximately 9.7 and 13.8 mg/dL, and urine samples were tested at concentrations of 5.7 and 14.9 mg/dL. Serum samples for the GLUCOSE assay were tested at concentrations of approximately 87 and 219 mg/dL. Serum samples for the UREA/BUN - UV assay were tested at concentrations of approximately 21.9 and 117 mg/dL, and urine samples were tested at concentrations of 866 and 1638 mg/dL. Samples were spiked with increasing concentrations of the potential interferents and analyzed in duplicate using the BioSystems BA400 analyzer. Interference was calculated as: (b-a)/a, where a and b are the concentration of measurand found in samples without (a) and with (b) interferent. The sponsor stated that interference was considered to be non-significant if the difference between the samples with and without interferent was within 10%.

The results of the interference studies are summarized in the table below.

| Analyte | Interferent | Highest concentration tested that did not show significant interference |
| --- | --- | --- |
| CALCIUM-CRESOLPHTHALEIN | Bilirubin | 30 mg/dL |
| | Hemoglobin | 500 mg/dL |
| | Triglycerides | 1300 mg/dL |
| GLUCOSE | Bilirubin | 12 mg/dL |
| | Hemoglobin | 604 mg/dL |
| | Triglycerides | 222 mg/dL |
| UREA/BUN-UV | Bilirubin | 30 mg/dL |
| | Hemoglobin | 500 mg/dL |
| | Triglycerides | 1625 mg/dL |

The following limitation is stated in the GLUCOSE device labeling:

This device has significant positive interference with triglycerides at levels above 222 mg/dL. Do not use lipemic samples with this assay.

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Exogenous interferences:

| Analyte | Matrix | Interferent | Highest concentration tested that did not show significant interference |
| --- | --- | --- | --- |
| CALCIUM-CRESOLPHTHALEIN | Serum | Acetaminophen | 20 mg/dL |
| | | Ascorbic Acid | 30 mg/dL |
| | | Acetylsalicylic Acid | 70 mg/dL |
| | Urine | Ascorbic Acid | 30 mg/dL |
| GLUCOSE | Serum | Acetaminophen | 20 mg/dL |
| | | Uric Acid | 20 mg/dL |
| | | Ascorbic Acid | 6 mg/dL |
| UREA/BUN-UV | Serum | Acetaminophen | 20 mg/dL |
| | | Ascorbic Acid | 30 mg/dL |
| | | Acetylsalicylic Acid | 70 mg/dL |
| | Urine | Ascorbic Acid | 30 mg/dL |

4. Assay Reportable Range:

| Analyte | Matrix | Claimed range (mg/dL) |
| --- | --- | --- |
| CALCIUM-CRESOLPHTHALEIN | Serum | 0.80 - 20.0 |
| | Urine | 3.97 – 30.0 |
| GLUCOSE | Serum | 2.0 - 500 |
| UREA/BUN-UV | Serum | 10.0 - 240 |
| | Urine | 635 - 12000 |

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Traceability:

The sponsor provided the following information on the traceability of the assays:

| Assay | Traceability |
| --- | --- |
| CALCIUM-CRESOLPHTHALEIN | SRM 956 (NIST) Standard Reference Materials. |
| GLUCOSE | SRM 965 (NIST) Standard Reference Materials. |
| UREA/BUN-UV | SRM 909 (NIST) Standard Reference Materials |

6. Detection Limit:

Detection capabilities studies for each analyte were evaluated based upon the CLSI EP17-A2 guideline.

Limit of blank (LoB) studies were performed by testing 5 blank samples in replicates of 4 over 3 days, on two lots for a total of 120 observations. LoB was defined as the highest result that can reasonably be expected from a blank sample for a given error probability with $\alpha = 0.05$.

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Limit of detection (LoD) studies were performed by testing 5 pools of human serum or urine with analyte concentrations close to expected detection limit for each analyte. Samples were tested in replicates of 4 over 3 days, on two lots for a total of 120 observations. The LoD was estimated based on a probability of error of 5% (β=0.05).

Limit of quantitation (LoQ) studies were performed using 4 to 5 pools of human serum or urine with analytes concentrations closed to the expected LoQ of the corresponding assay. Samples were tested in replicates of 4 over 3 days, on two lots for a total of 120 observations. The sponsor defines LoQ as the lowest concentration of a measurand with a CV ≤10%.

The results of the detection limit studies are presented in the table below:

| Assays | Matrix | LoB | LoD | LoQ | Claimed Range |
| --- | --- | --- | --- | --- | --- |
| CALCIUM-CRESOLPHTHALEIN | Serum | 0.22 | 0.46 | 0.80 | 0.80 - 20.0 mg/dL |
| | Urine | 0.19 | 0.47 | 3.97 | 3.97 - 20.0 mg/dL |
| GLUCOSE | Serum | 0.39 | 1.09 | 2.00 | 2.0 - 500 mg/dL |
| Urea/BUN-UV | Serum | 1.67 | 3.78 | 10.0 | 10.0-240 mg/dL |
| | Urine | 169 | 356 | 635 | 635-12000 mg/dL |

7. Assay Cut-Off:

Not applicable.

B Comparison Studies:

1. Method Comparison with Predicate Device:

Method comparison studies were conducted by testing native human serum, Lithium Heparin plasma and urine samples (as applicable) on CALCIUM-CRESOLPHTHALEIN, GLUCOSE and UREA/BUN-UV candidate assays on the BA400 analyzer and the predicate devices. To supplement testing across the reportable range of the assays, some samples were altered (spiked or diluted) and used to cover the full measuring range of each analyte.

The results of the regression analysis are summarized below:

| Analyte | Specimen Type | N | Slope | Intercept | R | Test range mg/dL | Claimed Measuring Range mg/dL |
| --- | --- | --- | --- | --- | --- | --- | --- |
| CALCIUM-CRESOLPH-THALEIN | Serum | 153 | 1.056 | -0.57 | 0.992 | 0.88 -17.9 | 0.80 - 20.0 |
| | Li Heparin Plasma | 146 | 1.033 | -0.336 | 0.996 | 1.20 - 19.8 | |
| | Urine | 77 | 0.97 | 0.0034 | 0.995 | 4.32 - 29.4 | 3.97 - 30.0 |
| GLUCOSE | Serum | 146 | 1.004 | 2.10 | 0.999 | 8.43 - 485 | 2.0 - 500 |

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| Analyte | Specimen Type | N | Slope | Intercept | R | Test range mg/dL | Claimed Measuring Range mg/dL |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Li Heparin Plasma | 127 | 0.997 | 0.28 | 0.996 | 5.58 - 432 | |
| UREA/BUN - UV | Serum | 111 | 0.99 | 2.34 | 0.997 | 10.8 - 232 | 10.0 - 240 |
| | Li Heparin Plasma | 112 | 1.00 | 3.02 | 0.998 | 12.4 -238 | |
| | Urine | 97 | 1.057 | -22.0 | 0.998 | 650-11462 | 635-12000 |

2. Matrix Comparison:

Not applicable. Different sample types were assessed in other analytical studies described above.

C Clinical Studies:

1. Clinical Sensitivity:

Not applicable.

2. Clinical Specificity:

Not applicable.

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

Not applicable.

D Clinical Cut-Off:

Not applicable.

E Expected Values/Reference Range:

The following reference ranges are cited from literature:

CALCIUM-CRESOLPHTHALEIN$^{(1)}$

8.6-10.0 mg/dL (2.15-2.50 mmol/L)

Urine: 100-300 mg/24-h (2.5-7.5 mmol/24-h)

GLUCOSE

Serum and plasma (Adult): 74 -100 mg/dL (4.10-5.60 mmol/L)$^{(2)}$

According to American Diabetes Association)$^{(3)}$, elevation of fasting plasma glucose values over

126 mg/dL (7.0 mmol/L) on more than one occasion is diagnostic of diabetes mellitus.

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UREA/BUN-UV$^{(2)}$

Serum and plasma: 14.4 – 48 mg/dL urea, 6 - 20 mg/dL BUN (5.14 – 17.14 mmol/L urea).

Urine: 26-43 g/24-h urea, 12-20 g/24 h BUN (428-714 mmol/24-h urea)

$^{(1)}$Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 3rd ed. Burtis C.A., Ashwood E.R., Bruns D.E., (WB Saunders Co, 1987).

$^{(2)}$Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 5th ed. Burtis C.A., Ashwood E.R., Bruns D.E., (WB Saunders Co, 2012).

$^{(3)}$American Diabetes Association. Classification and Diagnosis of Diabetes: Standards of Medical care in Diabetes. Diabetes Care 2020 Jan; 43(Supplement 1): S14-S31.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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