ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT

K123171 · HORIBA ABX SAS · CJY · Jul 3, 2013 · Clinical Chemistry

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

Intended 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)

Submission Summary (Full Text)

{0}------------------------------------------------

# Premarket Notification [510(k)] Summary

# JUL 0 3 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is : k123171

Company: Horiba ABX SAS Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 18 43 + (33) 4 67 14 15 17 Fax:

Contact Person: Caroline Ferrer ([e-mail])

Date Prepared: 02nd July, 2013

## A. Device Names:

The following reagent, controls & calibrators are for use in conjunction with the ABX PENTRA 400 instrument, cleared to market under K052007.

### REAGENTS :

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

## ABX PENTRA CALCIUM AS CP Calcium Arsenazo

Class II §862.1145 : Calcium test system CJY: Azo Dye, Calcium

### CALIBRATORS:

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

CONTROLS :

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

# ABX PENTRA Multical (Already cleared to market under K052007) Multical · Class II

§862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture

# ABX PENTRA N Control (Already cleared to market under K052007) N Control Class I

§862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)

{1}------------------------------------------------

| Trade/Proprietary Name: | ABX PENTRA P Control (Already cleared to market under K052007) |
|-------------------------|----------------------------------------------------------------|
| Common or Usual Name: | P Control |
| Device Class | Class I |
| Classification Name: | §862.1660 : Quality control material (assayed) |
| Product Code: | JJY ; Multi-Analyte Controls, All Kinds (assayed) |
| Trade/Proprietary Name: | ABX PENTRA Urine Control L/H (Already cleared to market) |
| under K070249) | |
| Common or Usual Name: | Urine control |

Urine Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)

# B. Substantial Equivalence:

Device Class

Product Code:

Classification Name:

The data and information supplied in this submission demonstrates substantial equivalence to their respective predicate devices:

| Submission device | Substantially equivalent<br>Predicate device |
|------------------------------|----------------------------------------------|
| ABX Pentra Calcium AS CP | K061575 |
| ABX Pentra Multical | K052007 |
| ABX Pentra N Control | K052007 |
| ABX Pentra P Control | K052007 |
| ABX Pentra Urine Control L/H | K070249 |

Comparison of new device (ABX Pentra Calcium AS CP ) with the predicate device l . ، (Olympus Calcium Arsenazo reagent):

- Similarities : -

| | Predicate device (K061575): | New Device : |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Device Name | Olympus Calcium Arsenazo<br>reagent | ABX Pentra Calcium AS CP |
| Indications for use | Olympus Calcium Arsenazo<br>reagent is a diagnostic reagent for<br>quantitative in vitro determination<br>of calcium in human serum, plasma<br>and urine by colorimetry.<br>Measurement of calcium is used in<br>the diagnosis and treatment of<br>parathyroid disease, a variety of<br>bone diseases, chronic renal disease<br>and tetany (intermittent muscular<br>contractions or spasms). | Identical |

{2}------------------------------------------------

| Analytes | Calcium | Identical |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Method | Calcium ions (Ca2+) react with<br>Arsenazo III (2,2'-[1,8-Dihydroxy-<br>3,6-disulphonaphthylene-2,7-<br>bisazo]- bisbenzenearsonic acid) to<br>form an intense purple coloured<br>complex. The absorbance of the<br>Ca-Arsenazo III complex is<br>measured bichromatically at<br>660/700 nm. The resulting increase<br>in absorbance of the reaction<br>mixture is directly proportional to<br>the calcium concentration in the<br>sample. | Identical |
| Specimen | Serum, plasma and urine | Identical |
| Closed reagent<br>stability | Until the expiration date printed on<br>the label when stored at 2-8°C | Identical |
| Format | Liquid | Identical |

#### Differences : -

.

| | Predicate device (K061575): | Device : |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Olympus Calcium Arsenazo<br>reagent | ABX Pentra Calcium AS CP |
| Manufactured by | Olympus Corp /Beckman Coulter | HORIBA ABX SAS, France |
| Instrument | Clinical chemistry analyzer | ABX PENTRA 400 |
| Component reagent<br>matrices | Mono reagent bottle, ready to use.<br>Final reactive ingredient: Arsenazo III | Mono reagent cassette, ready<br>to use.<br>Final reactive ingredient:<br>Identical |
| Label | - | Horiba Medical specific label |
| Notice | Beckman Coulter specific notice | Horiba Medical specific notice |
| Packaging | Mono reagent bottle<br>REAGENT: 4 x15 ml | Mono-reagent cassette :<br>REAGENT : 1x79 ml |
| Controls | Commercially available quality<br>control material (not included):<br>Controls Cat. No.ODC0003 and<br>ODC0004 for serum/plasma.<br>Biorad Liquichek Urine Chemistry<br>Controls Cat. No. 397 and 398 for<br>urine. | Recommended quality control<br>material (not included):<br>ABX Pentra N Control and<br>ABX Pentra P Control for<br>serum /plasma.<br>ABX Pentra Urine Control<br>L/H for urine. |
| Calibrators | Commercially available calibrator<br>(not included):<br>System Calibrator Cat. No. 66300<br>for serum/plasma application and<br>Urine Calibrator Cat. No.<br>ODC0025 for urine | Recommended calibration<br>material (not included):<br>ABX Pentra Multical |
| Open Reagent<br>stability | Once open, reagent stored on board<br>the instrument is stable for 90 days. | Once opened, the reagent<br>cassette placed in the<br>instrument (refrigerated |

.

.

·

.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

:

:

. .

{3}------------------------------------------------

| stable for 60 days |
|--------------------|
|--------------------|

- 2. Comparison of new device (ABX Pentra MULTICAL) with the predicate device (ABX Pentra MULTICAL already cleared to market under K052007):
The ABX Pentra MULTICAL was previously described and cleared by the FDA under K052007 and the following submissions K062737, K060205, K062180, K060854, K060434, K072115, K110137, K110530.

However we have added it in this submission, as it is used in combination with a parameter. The only difference between the previously cleared calibrator and the ones included in this submission is the parameter calibrated submitted to the FDA.

| | Predicate device (K052007): | Device : |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Device Name | ABX Pentra MULTICAL | ABX Pentra<br>MULTICAL |
| Manufactured by | Roche | Unchanged |
| Commercialized by | HORIBA ABX SAS, France | Unchanged |
| Instrument | ABX PENTRA 400 | Unchanged |
| Method : | Calibration of HORIBA Medical methods on<br>clinical chemistry analyzers | Unchanged |
| Component reagent<br>matrices | -Vial (lyophilizate)<br>-Human serum with chemical additives and tissue<br>extracts of human and animal origin | Unchanged |
| Biological additives | ALT (GPT), AST (GOT), Albumin, Aldolase,<br>Alkaline phosphatase, Amylase total, Pancreatic<br>Amylase, Cholesterol, Cholinesterase, Creatine<br>Kinase, Gamma-GT, GLDH, LD (LDH), Lipase,<br>Acid phosphatase, Total proteins | Unchanged |
| Format | Lyophilizate (to reconstitute with distilled/deionised<br>water - not provided) | Unchanged |
| Labels | Horiba Medical specific label | Unchanged |
| Notice | Horiba Medical specific notice | Unchanged |
| Packaging | Kit composed of :<br>10 x bottle, each with lyophilizate for 3 ml<br>calibrator | Unchanged |
| Performance data :<br>Calibration values | Determined using parameter-specific<br>methods (mentioned in the annex) under strictly<br>standardized conditions on HORIBA Medical | Unchanged |

#### Similarities : -

{4}------------------------------------------------

| | analyzers using HORIBA Medical system reagents<br>and HORIBA Medical master calibrator<br>The calibration value specified is the median<br>of the values obtained<br>The assigned values are indicated in the<br>annex enclosed in the kit<br>The values are lot-specific. | |
|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Performance data :<br>Closed stability | 24 months at 2-8°C | Unchanged |
| Performance data :<br>Components** stability<br>after reconstitution of the<br>calibrator | At 15 to 25°C : 8 hours<br>At 2 to 8°C: 2 days<br>At -25°C to -15°C: 2 weeks (when frozen once)<br>**Exceptions:<br>Stability of Direct Bilirubin<br>At 15 to 25°C: 3 hours<br>At 2 to 8°C: 8 hours<br>At -25°C to -15°C: 2 weeks (when frozen once)<br>Stability of Total Bilirubin<br>At 15 to 25°C: 6 hours<br>At 2 to 8°C: 1 day<br>At -25°C to -15°C: 2 weeks (when frozen once) | Unchanged |

·

#### Differences : -

:

:

.

י

-

.

| Device (K052007): | Device: | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Device Name | ABX Pentra MULTICAL | ABX Pentra<br>MULTICAL |
| Calibrated molecules | The exact calibrator values are<br>given in the enclosed annex | Updated to<br>include new<br>application<br>values for new<br>arsenazo calcium |
| Calibrated molecules: ALP, ALT,<br>Amylase, AST, Creatine kinase, GGT,<br>Lipase, Albumin, Direct Bilirubin, Total<br>Bilirubin, Calcium, Cholesterol,<br>Creatinine 120, Glucose HK, Glucose<br>PAP, Iron, Lactic Acid, Magnesium,<br>Phosphorus, Total Protein, Total protein<br>100, Triglyverides, Urea/BUN, Uric acid,<br>Enzymatic Creatinine, New Arsenazo<br>Calcium | Applications cleared K060205<br>CLIA K062180 K06318 K062737<br>CLIA CLIA K060434 K060325<br>K060325 K060205 K060854<br>K072115 - K062007 K062007<br>K060505 CLIA K060205<br>K060205 K060434 K072115<br>K060854 K060205 K060205<br>K110137 K110530 | New<br>Arsenazo<br>Calcium<br>Application not<br>cleared (in this<br>submission) |
| Value sheet/Annex | Horiba Medical specific annex | New Horiba<br>Medical specific<br>annex |

.

:

{5}------------------------------------------------

- Comparison of new device (ABX Pentra N CONTROL) with the predicate device (ABX 3. Pentra N CONTROL already cleared to market under K052007):
The ABX Pentra N CONTROL was previously described and cleared by the FDA under K052007 and the following submissions K062737, K060205, K060325, K062180, K060854, K060434, K072115, K110137, K110530.

However we have added it in this submission, as it is used in combination with a parameter. The only difference between the previously cleared control and the ones included in this submission is the parameter controlled submitted to the FDA.

| | Predicate device (K052007): | Device : |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Device Name | ABX Pentra N Control | ABX Pentra<br>N Control |
| Manufactured by | Roche | Unchanged |
| Commercialized by | HORIBA ABX SAS, France | Unchanged |
| Instrument | ABX PENTRA 400 | Unchanged |
| Method : | Quality control by monitoring accuracy and precision<br>for the quantitative methods as specified in the<br>enclosed value sheet<br>- Concentrations and activities are mostly in the<br>normal or near-normal range | Unchanged |
| Component reagent<br>matrices | -Vial (lyophilizate)<br>-Human serum with chemical additives and tissue<br>extracts of human and animal origin | Unchanged |
| Biological additives | ALT (GPT), AST (GOT), Albumin, Aldolase,<br>Alkaline phosphatase, Amylase total, Pancreatic<br>Amylase, Cholesterol, Cholinesterase, Creatine<br>Kinase, Gamma-GT, GLDH, LD (LDH), Lipase, Acid<br>phosphatase, Total proteins | Unchanged |
| Format | Lyophilizate (to reconstitute with distilled/deionised<br>water - not provided) | Unchanged |
| Labels | Horiba Medical specific label | Unchanged |
| Notice | Horiba Medical specific notice | Unchanged |
| Packaging | Kit composed of :<br>10 x bottle, each with lyophilizate for 5 ml control | Unchanged |
| Performance data :<br>Theoretical values and<br>confidence intervals | - The theoretical value specified is the median of the<br>values obtained, the confidence interval equals the<br>theoretical value ± 3SD (SD = Standard | Unchanged |

# Similarities :

{6}------------------------------------------------

| | Deviation)<br>- The assigned values are indicated in the annex<br>enclosed in the kit.<br>-The values are lot-specific. | |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Performance data :<br>Closed stability | 30 months at 2-8°C | Unchanged |
| Components** stability<br>after reconstitution of<br>the control | At 15-25°C : 12 hours<br>At 2-8°C : 5 days<br>At (-15°C) - (-25°C) : 4 weeks (when frozen once)<br>**Exceptions:<br>Stability of Total Bilirubin<br>At 15-25°C : 8 hours<br>At 2 - 8°C : 24 hours<br>At (-15°C)- (-25°C) :2 weeks (when frozen once)<br>Stability of Direct Bilirubin<br>At 15 - 25°C : 4hours<br>At 2 - 8°C : 8 hours<br>At (-15°C) - (-25°C) :2 weeks (when frozen once) | Unchanged |

# Differences :

| | Differences : | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | Predicate device (K052007): | Device : |
| Device Name | ABX Pentra N Control | ABX Pentra N<br>Control |
| Controlled molecules | The exact control values are given in the<br>enclosed annex | Updated to<br>include new<br>application<br>values for new<br>arsenazo<br>calcium |
| Controlled molecules : | Applications cleared : | Application not<br>cleared under<br>this submission: |
| ALP, ALT, Amylase, AST, Creatine<br>kinase, GGT, Lipase, Albumin, Direct<br>Bilirubin, Total Bilirubin, Calcium,<br>Chloride, Cholesterol, HDL, LDL,<br>Creatinine 120, Glucose HK, Glucose<br>PAP, Iron, Lactic Acid, Magnesium,<br>Phosphorus, Potassium, Sodium,<br>Total Protein, Total Protein 100,<br>Triglycerides, Urea/BUN, Uric acid,<br>Enzymatic Creatinine, new arsenazo<br>calcium | K060205, CLIA, K062180, K06318,<br>K062737, CLIA, CLIA, K060434,<br>K060325, K060325, K060205,<br>K052007, K060854, K060854,<br>K060854, K072115,K052007,<br>K052007, K060205, CLIA, K060205,<br>K060205, K052007, K052007,<br>K060434, K072115, K060854,<br>K060205, K060205, K110137<br>K110530, - . | - New<br>arsenazo<br>calcium<br>Application not<br>cleared (in this<br>submission) |
| Value sheet / Annex | Horiba Medical specific annex | New Horiba<br>Medical |

{7}------------------------------------------------

| Comments of the controlled controlled contraction of the contribution coment of the interestinational dell'Articles and Children comer of Alternal program and Metropolities i<br>PARTIC PARTY COLLECT | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SALES CONSULTION CONSULTION CONSULTION CONSULTION POST CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTIO<br>No. of the children and any and the company of a come<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ANALAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA |
| | |
| | |
| .<br>SIL-LIAA-AUSBAL-A-L-L-L-A-A-L-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-<br>------------------------------------------------------------------------------ | A S S S S S A L A L A L A B A B A B A B A B A B A B A B A B A B A B A B A B .<br>Allenover Annual CR A & A & A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A B A |
| | |

- 4. Comparison of new device (ABX Pentra P CONTROL) with the predicate device (ABX Pentra P CONTROL already cleared to market under K052007):
The ABX Pentra P CONTROL was previously described and cleared by the FDA under K052007 and the following submissions K062737, K060205, K060325, K062180, K060854, K060434, K072115, K110137, K110530.

However we have added it in this submission, as it is used in combination with a parameter. The only difference between the previously cleared control and the ones included in this submission is the parameter controlled submitted to the FDA.

| | Predicate device (K052007): | Device : |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Device Name | ABX Pentra P Control | ABX Pentra<br>P Control |
| Manufactured by | Roche | Unchanged |
| Commercialized by | HORIBA ABX SAS, France | Unchanged |
| Instrument | ABX PENTRA 400 | Unchanged |
| Method : | Quality control by monitoring accuracy and precision<br>for the quantitative methods as specified in the enclosed<br>value sheet<br>Concentrations and activities are mostly in the normal<br>or near-normal range | Unchanged |
| Component reagent<br>matrices | Vial (lyophilizate)<br>Human serum with chemical additives and tissue<br>extracts of human and animal origin | Unchanged |
| Biological additives | ALT (GPT), AST (GOT), Albumin, Aldolase, Alkaline<br>phosphatase, Amylase total, Amylase Pancreatic,<br>Cholesterol, Cholinesterase, Creatine Kinase, Gamma-<br>GT, GLDH, LD (LDH), Lipase, Acid phosphatase,<br>Total proteins | Unchanged |
| Format | Lyophilizate (to reconstitute with distilled/deionised<br>water - not provided) | Unchanged |
| Labels | Horiba Medical specific label | Unchanged |
| Notice | Horiba Medical specific notice | Unchanged |
| Packaging | Kit composed of :<br>10 x bottle, each with lyophilizate for 5 ml control | Unchanged |
| Performance data :<br>Theoretical values and | - The theoretical value specified is the median of the<br>values obtained, the confidence interval equals the | Unchanged |

# Similarities :

{8}------------------------------------------------

| confidence intervals | theoretical value ± 3SD (SD = Standard Deviation)<br>- The assigned values are indicated in the annex<br>enclosed in the kit.<br>-The values are lot-specific. | |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Performance data :<br>Closed stability | 30 months at 2-8°C. | Unchanged |
| Performance data :<br>Components** stability<br>after reconstitution of<br>the control | At 15-25°C : 12 hours.<br>At 2-8°C : 5 days<br>At (-15°C) - (-25°C) : 1 month (when frozen once)<br>**Exceptions:<br>Stability of Total Bilirubin<br>At 15-25°C : 8 hours<br>At 2 - 8°C : 24 hours<br>At (-15°C)- (-25°C) :2 weeks (when frozen once)<br>Stability of Direct Bilirubin<br>At 15 - 25°C : 4hours<br>At 2 - 8°C : 8 hours<br>At (-15°C) - (-25°C) :2 weeks (when frozen once) | Unchanged |

·

:

·

.

| Differences : | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| | Predicate device (K052007): | Device : |
| Device Name | ABX Pentra P Control | ABX Pentra P<br>Control |
| Controlled molecules | The exact control values are given in the<br>enclosed annex | Updated to<br>include new<br>application<br>values for new<br>arsenazo<br>calcium |
| Controlled molecules : | Applications cleared : | Application not<br>cleared under<br>this<br>submission: |
| ALP, ALT, Amylase, AST, Creatine<br>kinase, GGT, Lipase, Albumin, Direct<br>Bilirubin, Total Bilirubin, Calcium,<br>Chloride, Cholesterol, HDL, LDL,<br>Creatinine 120, Glucose HK, Glucose<br>PAP, Iron, Lactic Acid, Magnesium,<br>Phosphorus, Potassium, Sodium,<br>Total Protein, Total Protein 100,<br>Triglycerides, Urea/BUN, Uric acid,<br>Enzymatic Creatinine, New arsenazo<br>calcium | K060205, CLIA, K062180, K06318,<br>K062737, CLIA, CLIA, K060434,<br>K060325, K060325, K060205,<br>K052007, K060854, K060854,<br>K060854, K072115, K052007,<br>K052007, K060205, CLIA, K060205,<br>K060205, K052007, K052007,<br>K060434, K072115, K060854,<br>K060205, K060205, K110137 K110530 | New arsenazo<br>calcium<br>Application not<br>cleared (in this<br>submission) |

·

-

{9}------------------------------------------------

| Value sheet / Annex | Horiba Medical specific annex | New Horiba<br>Medical<br><i>specific</i> annex |
|---------------------|-------------------------------|------------------------------------------------|
|---------------------|-------------------------------|------------------------------------------------|

- 5. Comparison of new device (ABX Pentra URINE CONTROL L/H) with the predicate device (ABX Pentra URINE CONTROL L/H already cleared to market under K070249):
The ABX Pentra URINE CONTROL L/H was previously described and cleared by the FDA under K070249 and the following submission K072115, K110137, K110530.

However we have added it in this submission, as it is used in combination with a parameter. The only difference between the previously cleared control and the ones included in this submission is the parameter controlled submitted to the FDA.

| | Predicate device (K070249): | Device : |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Device Name | ABX Pentra Urine Control L/H | ABX Pentra<br>Urine Control<br>L/H |
| Manufactured by | Biorad | Unchanged |
| Commercialized by | HORIBA ABX SAS, France | Unchanged |
| Instrument | ABX PENTRA 400 | Unchanged |
| Method : | Quality control by monitoring accuracy and<br>precision for the quantitative methods as specified<br>in the enclosed value sheet. | Unchanged |
| Component reagent<br>matrices | Vial (liquid)<br>2 levels : Low / High<br>Human urine with added constituents of human<br>and animal origin, chemicals, preservatives and<br>stabilizers. | Unchanged |
| Format | Liquid, ready to use | Unchanged |
| Labels | Horiba Medical specific label | Unchanged |
| Notice | Horiba Medical specific notice | Unchanged |
| Packaging | Kit composed of :<br>1 x 10 ml Low Control<br>1 x 10 ml High Control | Unchanged |
| Performance data :<br>Theoretical values and<br>confidence intervals | - The assigned values are determined by<br>calculating the median value obtained from<br>multiple determinations.<br>- The assigned values for both Low and High<br>controls are lot specific<br>- The assigned values and precise confidence<br>interval are indicated in the annex enclosed in the | Unchanged |

- Similarities :

{10}------------------------------------------------

| COOL COLLECT COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONTROLLERS CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION CONSTITUTION CON | from and controllection of the consisted on the manufactures and consistence and consistence and concerner manus concerner manus concerner manus concerner manus concerner and<br>A-SALEAA LABILIBLASA FRAUBURA LILIBELLUBA BARAUSAN<br>I financing and more and more of the more and annual many and estable production and establish briques to relations and established in the manus and management of the managem | AAIliAdt A. C.O.Oblogs A4/0400 A4/018040 Co. Buy BOW YOU CONTENT AN AA. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ставления в пристемента с мерека мести приводительные присами принаментации принами принами крастика кактические мательно<br>A CARRENT COLLECTION COLLECTION CARRENAL CLANDS A CLASS COLLECALLACING CALL CALLEMENT PARTIEN PARTIEN PARTIEN PARTIEN PARTIEN PARTIEN PARTIEN PARTIEN PARTIEN PARTIENT PARTIEN | |
| | | |

| Differences : | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--|
| | Predicate device (K070249): | Device : | |
| Device Name | ABX Pentra Urine Control L/H | ABX Pentra Urine<br>Control L/H | |
| Controlled molecules | The exact control values are given<br>in the enclosed annex | Updated to include<br>new application<br>values for new<br>arsenazo calcium | |
| Controlled molecules : | Applications cleared : | Application not<br>cleared under this<br>submission: | |
| Amylase, Calcium, Phosphorus,<br>Glucose HK, Urea/BUN, Uric Acid,<br>Total Proteins (Urinary), Creatinine<br>120, Enzymatic Creatinine, New<br>Arsenazo Calcium | K070249, K070249, K070249,<br>K070146, K070146, K070146,<br>K070146, K072115, K110137<br>K110530, - | New Arsenazo<br>Calcium Application<br>not cleared (in this<br>submission) | |
| Value sheet / Annex | Horiba Medical specific annex | New Horiba Medical<br>specific annex | |

# C. Description:

All the reagent, controls and calibrator included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

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 colourimetric method. It is composed of a monoreagent cassette (79 mL). The reagent is chemical solution with additives.

The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer.

This calibrator is provided in ten vials of 3 ml.

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 added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA

{11}------------------------------------------------

ABX SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.

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 added as required to obtain given component levels. 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.

## D. Intended Use:

The reagent in this submission is intended for use on the ABX PENTRA 400.

The controls and calibrator are intended for use in association with the above reagent on the ABX PENTRA 400.

## 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.

{12}------------------------------------------------

# E. Discussion of nonclinical tests submitted:

All the performance studies were conducted using the ABX Pentra 400 clinical chemistry analyzer.

- 1. Detection limit
The detection limits are determined according to CLSI (NCCLS), EP17-A protocol: Protocols for determination of limits of detection and limits of quantitation. Approved Guideline, CLSI (NCCLS) document EP17-A (2004) 24 (34). Serum/Plasma : 0.28 mg/dl Urine : 0.23 mg/dl

- 2. Limit of quantitation
The limits of quantitation are determined according to CLSI (NCCLS), EP17-A protocol: Protocols for determination of limits of detection and limits of quantitation. Approved Guideline, CLSI (NCCLS) document EP17-A (2004) 24 (34). Serum/Plasma : 1.54 mg/dl Urine : 0.64 mg/dl

#### Repeatability (within-run precision) 3.

3 specimens of low, medium and high concentration and 2 controls are tested 20 times according to the recommendations found in the Valtec protocol : Vassault A. Grafmever D, Naudin C et al. Protocole de validation de techniques (document B). Ann. Biol. Clin. (1986) 44: 686-745.

For serum/plasma

| | Mean value (mg/dl) | CV% |
|--------------------|--------------------|------|
| Control specimen 1 | 8.39 | 0.49 |
| Control specimen 2 | 12.53 | 0.37 |
| Specimen 1 | 6.91 | 0.71 |
| Specimen 2 | 9.18 | 0.40 |
| Specimen 3 | 13.15 | 0.43 |

For urine .

| | Mean value (mg/dl) | CV% |
|--------------------|--------------------|------|
| Control specimen 1 | 7.27 | 0.62 |
| Control specimen 2 | 10.86 | 0.76 |
| Specimen 1 | 7.73 | 0.46 |
| Specimen 2 | 10.50 | 0.56 |
| Specimen 3 | 14.50 | 0.37 |

Reproductibility (total precision) 4.

> 3 specimens of low, medium and high levels and 2 controls are tested in duplicate for 20 days (2 series per day) according to the recommendations found in the CLSI (NCCLS),

{13}------------------------------------------------

EPS-A2 protocol : Evaluation of Precision Performance of Quantitative Measurement Method. Approved Guideline, CLSI (NCCLS) document EP5-A2 (2004) 24 (25).

### For serum/plasma

| | Mean value (mg/dl) | CV% |
|--------------------|--------------------|------|
| Control specimen 1 | 8.72 | 1.44 |
| Control specimen 2 | 13.02 | 1.49 |
| Specimen 1 | 7.03 | 1.56 |
| Specimen 2 | 9.47 | 1.54 |
| Specimen 3 | 12.93 | 1.54 |

### For urine

| | Mean value (mg/dl) | CV% |
|--------------------|--------------------|------|
| Control specimen 1 | 7.28 | 1.45 |
| Control specimen 2 | 10.71 | 1.50 |
| Specimen 1 | 7.70 | 1.57 |
| Specimen 2 | 10.27 | 1.57 |
| Specimen 3 | 14.21 | 1.56 |

#### న. Measuring range

The assay confirmed a measuring range from 4.0 mg/dl - 18.05 mg/dl (for serum/plasma) and 0.64 mg/dl - 18.05 mg/dl (for urine), with an automatic post-dilution up to 54.15 mg/dl.

According to the recommendations found in the CLSI (NCCLS). EP6-A protocol : Evaluation of the Linearity of Quantitative Analytical Methods. Approved Guideline, CLSI (NCCLS) document EP6-A (2003) 23 (16), the reagent linearity for serum/plasma and urine has been assessed up to 18.05 mg/dl. and with automatic post-dilution : 54.15 mg/dl.

- 6. Method comparison
According to the recommendations found in the CLSI (NCCLS), EP9-A2 protocol: Method Comparison and Bias Estimation Using Patient Samples. Approved Guideline, 2nd ed., CLSI (NCCLS) document EP9-A2 (2002) 22 (19), patient samples (n=145 for serum/plasma; n=143 for urine) are correlated with a commercial reagent taken as reference.

Values ranged from 4.17 mg/dl to 15.76 mg/dl for serum/plasma and 0.64 mg/dl to 17.80 mg/dl for urine.

The equations for the allometric line obtained using Passing- Bablock regression procedure: Passing H, Bablock W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J. Clin. Chem. Clin. Biochem. (1983) 21: 709-20., are:

For serum/plasma: Y = 1.00 x + 0.04 (mg/dl) with r2 = 0.9903 For urine: Y = 0.98 x -0.03 (mg/dl) with r2 = 0.993

{14}------------------------------------------------

## 7. Matrix comparison study

A matrix comparison study between serum and lithium plasma samples was performed . using 32 paired serum and lithium plasma samples, ranging in calcium concentration from 4.0 mg/dL to 17.5 mg/dL (3 samples were altered). Each sample was tested in singulate using the ABX Pentra Calcium AS CP assay reagent. Linear regression analysis of the plot of serum (x-axis) and lithium plasma (y-axis) samples showed the following relationships between the matrix types: y = 1.006x - 0.0022, r2 = 0.996

#### 8. Calibration stability

The reagent is calibrated on Day 0. The calibration stability is checked by testing 2 control specimens.

The calibration stability is 10 days for serum/plasma and urine.

A recalibration is recommended when reagent lots change, and when quality control results fall outside the range established.

## 9. Reagent stability

.

.

Closed stability: 24 months at 2-8℃ On-board stability: 60 days at 2-8°C

| ABX PENTRA Multical: | | | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--|
| Analytes | Already cleared<br>(K052007, K060205, K060318,<br>K060325, K060854, K062180,<br>K062737, K060434, K072115,<br>K110137, K110530) | Included in this submission | |
| Alkaline phosphatase | √ | √ | |
| Alanine aminotransferase | √ | √ | |
| Amylase | √ | √ | |
| Aspartate aminotransferase | √ | √ | |
| Creatine kinase | √ | √ | |
| GGT | √ | √ | |
| LDH | √ | √ | |
| Lipase | √ | √ | |
| Albumin | √ | √ | |
| Direct Bilirubin | √ | √ | |
| Total Bilirubin | √ | √ | |
| Calcium | √ | √ | |
| New Calcium AS | | √ | |
| Cholesterol | √ | √ | |
| Creatinine 120 | √ | √ | |
| Enzymatic Creatinine CP | √ | √ | |

# F. CALIBRATOR

{15}------------------------------------------------

| ABX PENTRA Multical: | | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| Glucose HK | √ | √ |
| Glucose PAP |…