Predicate Devices

Reference Devices

K052007, K062737, K060205, K062180, K060854, K060434, K072115, K110137, K110530, K070249, K07249, K060318, K060325

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic reagent and associated calibrators and controls for a clinical chemistry analyzer, relying on a colorimetric method. There is no mention of AI, ML, or any computational methods beyond basic data processing for quantitative measurements and statistical analysis of performance.

Therapeutic

No
The device is described as a "diagnostic reagent for quantitative in vitro determination of calcium" and "an in vitro diagnostic assay." It is used for diagnosis, not treatment, making it a diagnostic device, not a therapeutic one.

Diagnostic

Yes

The "ABX Pentra Calcium AS CP reagent" is described as a "diagnostic reagent for quantitative in vitro determination of calcium" and its "Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany". This clearly indicates its intended use in aiding diagnosis. The "ABX PENTRA 400 Clinical Chemistry analyzer" on which these reagents are used is also referred to as a "clinical chemistry analyzer," which are devices used for diagnostic testing.

SaMD (Software as a Medical Device)

No

The device description clearly states that the submission includes reagents, controls, and calibrators, which are physical chemical solutions and materials, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the ABX Pentra Calcium AS CP reagent is a "diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine". It also mentions its use in the "diagnosis and treatment" of various medical conditions.
In Vitro: The term "in vitro" is used multiple times, indicating that the testing is performed outside of the living body, typically in a laboratory setting.
Diagnostic: The primary purpose is to provide information used in the diagnosis and treatment of diseases.
Device Description: The description of the reagent, calibrator, and controls clearly indicates they are used for testing biological samples (serum, plasma, urine) on a clinical chemistry analyzer.

The associated calibrators and controls are also considered IVDs as they are essential components for the proper functioning and quality control of the diagnostic assay.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

CJY, JIX, JJY

Device 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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Detection limit: Serum/Plasma: 0.28 mg/dl, Urine: 0.23 mg/dl
Limit of quantitation: Serum/Plasma: 1.54 mg/dl, Urine: 0.64 mg/dl
Repeatability (within-run precision):
- Serum/plasma: 3 specimens and 2 controls tested 20 times. Control specimen 1 (8.39 mg/dl, CV% 0.49), Control specimen 2 (12.53 mg/dl, CV% 0.37), Specimen 1 (6.91 mg/dl, CV% 0.71), Specimen 2 (9.18 mg/dl, CV% 0.40), Specimen 3 (13.15 mg/dl, CV% 0.43).
- Urine: 3 specimens and 2 controls tested 20 times. Control specimen 1 (7.27 mg/dl, CV% 0.62), Control specimen 2 (10.86 mg/dl, CV% 0.76), Specimen 1 (7.73 mg/dl, CV% 0.46), Specimen 2 (10.50 mg/dl, CV% 0.56), Specimen 3 (14.50 mg/dl, CV% 0.37).
Reproducibility (total precision):
- Serum/plasma: 3 specimens and 2 controls tested in duplicate for 20 days. Control specimen 1 (8.72 mg/dl, CV% 1.44), Control specimen 2 (13.02 mg/dl, CV% 1.49), Specimen 1 (7.03 mg/dl, CV% 1.56), Specimen 2 (9.47 mg/dl, CV% 1.54), Specimen 3 (12.93 mg/dl, CV% 1.54).
- Urine: 3 specimens and 2 controls tested in duplicate for 20 days. Control specimen 1 (7.28 mg/dl, CV% 1.45), Control specimen 2 (10.71 mg/dl, CV% 1.50), Specimen 1 (7.70 mg/dl, CV% 1.57), Specimen 2 (10.27 mg/dl, CV% 1.57), Specimen 3 (14.21 mg/dl, CV% 1.56).
Measuring range: 4.0 mg/dl - 18.05 mg/dl (serum/plasma) and 0.64 mg/dl - 18.05 mg/dl (urine), with an automatic post-dilution up to 54.15 mg/dl. Linearity assessed up to 18.05 mg/dl (with post-dilution up to 54.15 mg/dl).
Method comparison: Patient samples (n=145 for serum/plasma; n=143 for urine) correlated with a commercial reagent.
- 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.
- Regression equations:
  - 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
Matrix comparison study: 32 paired serum and lithium plasma samples tested. Calcium concentration from 4.0 mg/dL to 17.5 mg/dL.
- Linear regression: y = 1.006x - 0.0022, r2 = 0.996
Calibration stability: 10 days for serum/plasma and urine.
Reagent stability: Closed stability: 24 months at 2-8°C, On-board stability: 60 days at 2-8°C.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K061575, K052007, K070249

Reference Device(s)

Initially, the text mentions K052007, K062737, K060205, K062180, K060854, K060434, K072115, K110137, K110530 as devices that ABX Pentra MULTICAL, N CONTROL and P CONTROL were previously cleared under. Additionally, K070249, K072115, K110137, K110530 are listed for ABX Pentra Urine Control L/H. The tables under F. CALIBRATOR and G. CONTROLS include a column "Already cleared (K052007, K060205, K060318, K060325, K060854, K062180, K062737, K060434, K072115, K110137, K110530)" for "ABX PENTRA Multical", "ABX PENTRA N Control", and "ABX PENTRA P Control". For "ABX PENTRA Urine Control L/H", the table lists "Already cleared (K07249, K072115, K110137, K110530)".

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1145 Calcium test system.

(a)
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).(b)
Classification. Class II.

Summary

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 (caroline.ferrer@horiba.com)

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
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
reagent	ABX Pentra Calcium AS CP
Indications for use	Olympus Calcium Arsenazo
reagent is a diagnostic reagent for
quantitative in vitro determination
of calcium in human serum, plasma
and urine by colorimetry.
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).	Identical

2

Analytes	Calcium	Identical
Method	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 coloured
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.	Identical
Specimen	Serum, plasma and urine	Identical
Closed reagent
stability	Until the expiration date printed on
the label when stored at 2-8°C	Identical
Format	Liquid	Identical

Differences : -

.

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

.

·

.

:

. .

3

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

1. 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
MULTICAL
Manufactured by	Roche	Unchanged
Commercialized by	HORIBA ABX SAS, France	Unchanged
Instrument	ABX PENTRA 400	Unchanged
Method :	Calibration of HORIBA Medical methods on
clinical chemistry analyzers	Unchanged
Component reagent
matrices	-Vial (lyophilizate)
-Human serum with chemical additives and tissue
extracts of human and animal origin	Unchanged
Biological additives	ALT (GPT), AST (GOT), Albumin, Aldolase,
Alkaline phosphatase, Amylase total, Pancreatic
Amylase, Cholesterol, Cholinesterase, Creatine
Kinase, Gamma-GT, GLDH, LD (LDH), Lipase,
Acid phosphatase, Total proteins	Unchanged
Format	Lyophilizate (to reconstitute with distilled/deionised
water - not provided)	Unchanged
Labels	Horiba Medical specific label	Unchanged
Notice	Horiba Medical specific notice	Unchanged
Packaging	Kit composed of :
10 x bottle, each with lyophilizate for 3 ml
calibrator	Unchanged
Performance data :
Calibration values	Determined using parameter-specific
methods (mentioned in the annex) under strictly
standardized conditions on HORIBA Medical	Unchanged

Similarities : -

4

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

·

Differences : -

:

.

י

.

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

Concentrations and activities are mostly in the
normal or near-normal range | Unchanged |
| Component reagent
matrices | -Vial (lyophilizate)
-Human serum with chemical additives and tissue
extracts of human and animal origin | Unchanged |
| Biological additives | ALT (GPT), AST (GOT), Albumin, Aldolase,
Alkaline phosphatase, Amylase total, Pancreatic
Amylase, Cholesterol, Cholinesterase, Creatine
Kinase, Gamma-GT, GLDH, LD (LDH), Lipase, Acid
phosphatase, Total proteins | Unchanged |
| Format | Lyophilizate (to reconstitute with distilled/deionised
water - not provided) | Unchanged |
| Labels | Horiba Medical specific label | Unchanged |
| Notice | Horiba Medical specific notice | Unchanged |
| Packaging | Kit composed of :
10 x bottle, each with lyophilizate for 5 ml control | Unchanged |
| Performance data :
Theoretical values and
confidence intervals | - The theoretical value specified is the median of the
values obtained, the confidence interval equals the
theoretical value ± 3SD (SD = Standard | Unchanged |

Similarities :

6

| | Deviation)

The assigned values are indicated in the annex
enclosed in the kit.
-The values are lot-specific. | |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Performance data :
Closed stability | 30 months at 2-8°C | Unchanged |
| Components** stability
after reconstitution of
the control | At 15-25°C : 12 hours
At 2-8°C : 5 days
At (-15°C) - (-25°C) : 4 weeks (when frozen once)
**Exceptions:
Stability of Total Bilirubin
At 15-25°C : 8 hours
At 2 - 8°C : 24 hours
At (-15°C)- (-25°C) :2 weeks (when frozen once)
Stability of Direct Bilirubin
At 15 - 25°C : 4hours
At 2 - 8°C : 8 hours
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
Control
Controlled molecules	The exact control values are given in the
enclosed annex	Updated to
include new
application
values for new
arsenazo
calcium
Controlled molecules :	Applications cleared :	Application not
cleared under
this submission:
ALP, ALT, Amylase, AST, Creatine
kinase, GGT, Lipase, Albumin, Direct
Bilirubin, Total Bilirubin, Calcium,
Chloride, Cholesterol, HDL, LDL,
Creatinine 120, Glucose HK, Glucose
PAP, Iron, Lactic Acid, Magnesium,
Phosphorus, Potassium, Sodium,
Total Protein, Total Protein 100,
Triglycerides, Urea/BUN, Uric acid,
Enzymatic Creatinine, new arsenazo
calcium	K060205, CLIA, K062180, K06318,
K062737, CLIA, CLIA, K060434,
K060325, K060325, K060205,
K052007, K060854, K060854,
K060854, K072115,K052007,
K052007, K060205, CLIA, K060205,
K060205, K052007, K052007,
K060434, K072115, K060854,
K060205, K060205, K110137
K110530, - .	- New
arsenazo
calcium
Application not
cleared (in this
submission)
Value sheet / Annex	Horiba Medical specific annex	New Horiba
Medical

7

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1. 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
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
for the quantitative methods as specified in the enclosed
value sheet
Concentrations and activities are mostly in the normal
or near-normal range	Unchanged
Component reagent
matrices	Vial (lyophilizate)
Human serum with chemical additives and tissue
extracts of human and animal origin	Unchanged
Biological additives	ALT (GPT), AST (GOT), Albumin, Aldolase, Alkaline
phosphatase, Amylase total, Amylase Pancreatic,
Cholesterol, Cholinesterase, Creatine Kinase, Gamma-
GT, GLDH, LD (LDH), Lipase, Acid phosphatase,
Total proteins	Unchanged
Format	Lyophilizate (to reconstitute with distilled/deionised
water - not provided)	Unchanged
Labels	Horiba Medical specific label	Unchanged
Notice	Horiba Medical specific notice	Unchanged
Packaging	Kit composed of :
10 x bottle, each with lyophilizate for 5 ml control	Unchanged
Performance data :
Theoretical values and	- The theoretical value specified is the median of the
values obtained, the confidence interval equals the	Unchanged

Similarities :

8

| confidence intervals | theoretical value ± 3SD (SD = Standard Deviation)

The assigned values are indicated in the annex
enclosed in the kit.
-The values are lot-specific. | |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Performance data :
Closed stability | 30 months at 2-8°C. | Unchanged |
| Performance data :
Components** stability
after reconstitution of
the control | At 15-25°C : 12 hours.
At 2-8°C : 5 days
At (-15°C) - (-25°C) : 1 month (when frozen once)
**Exceptions:
Stability of Total Bilirubin
At 15-25°C : 8 hours
At 2 - 8°C : 24 hours
At (-15°C)- (-25°C) :2 weeks (when frozen once)
Stability of Direct Bilirubin
At 15 - 25°C : 4hours
At 2 - 8°C : 8 hours
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
Control
Controlled molecules	The exact control values are given in the
enclosed annex	Updated to
include new
application
values for new
arsenazo
calcium
Controlled molecules :	Applications cleared :	Application not
cleared under
this
submission:
ALP, ALT, Amylase, AST, Creatine
kinase, GGT, Lipase, Albumin, Direct
Bilirubin, Total Bilirubin, Calcium,
Chloride, Cholesterol, HDL, LDL,
Creatinine 120, Glucose HK, Glucose
PAP, Iron, Lactic Acid, Magnesium,
Phosphorus, Potassium, Sodium,
Total Protein, Total Protein 100,
Triglycerides, Urea/BUN, Uric acid,
Enzymatic Creatinine, New arsenazo
calcium	K060205, CLIA, K062180, K06318,
K062737, CLIA, CLIA, K060434,
K060325, K060325, K060205,
K052007, K060854, K060854,
K060854, K072115, K052007,
K052007, K060205, CLIA, K060205,
K060205, K052007, K052007,
K060434, K072115, K060854,
K060205, K060205, K110137 K110530	New arsenazo
calcium
Application not
cleared (in this
submission)

·

9

| Value sheet / Annex | Horiba Medical specific annex | New Horiba
Medical
specific annex |

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

1. 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
Urine Control
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
precision for the quantitative methods as specified
in the enclosed value sheet.	Unchanged
Component reagent
matrices	Vial (liquid)
2 levels : Low / High
Human urine with added constituents of human
and animal origin, chemicals, preservatives and
stabilizers.	Unchanged
Format	Liquid, ready to use	Unchanged
Labels	Horiba Medical specific label	Unchanged
Notice	Horiba Medical specific notice	Unchanged
Packaging	Kit composed of :
1 x 10 ml Low Control
1 x 10 ml High Control	Unchanged
Performance data :
Theoretical values and
confidence intervals	- The assigned values are determined by
calculating the median value obtained from
multiple determinations.

The assigned values for both Low and High
controls are lot specific
The assigned values and precise confidence
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
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|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ставления в пристемента с мерека мести приводительные присами принаментации принами принами крастика кактические мательно
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
Control L/H
Controlled molecules	The exact control values are given
in the enclosed annex	Updated to include
new application
values for new
arsenazo calcium
Controlled molecules :	Applications cleared :	Application not
cleared under this
submission:
Amylase, Calcium, Phosphorus,
Glucose HK, Urea/BUN, Uric Acid,
Total Proteins (Urinary), Creatinine
120, Enzymatic Creatinine, New
Arsenazo Calcium	K070249, K070249, K070249,
K070146, K070146, K070146,
K070146, K072115, K110137
K110530, -	New Arsenazo
Calcium Application
not cleared (in this
submission)
Value sheet / Annex	Horiba Medical specific annex	New Horiba Medical
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
1. 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.

1. 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
(K052007, K060205, K060318,
K060325, K060854, K062180,
K062737, K060434, K072115,
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	√	√
Iron	√	√
Lactic acid	√	√
Magnesium	√	√
Phosphorus	√	√
Total Protein	√	√
Total Protein 100	√	√
Triglycerides	√	√
Urea / Blood Urea Nitrogen	√	√
Uric acid	√	√
Format	Lyophilized human serum with chemical additives and materials of biological origin
Stability	Closed stability: 24 months at 2-8°C
Open stability:
Once opened, the calibrator components** are stable for:
8 hours at 15°C to 25°C
2 days at 2°C to 8°C
2 weeks at -25°C to -15°C
**Exceptions
Direct Bilirubin
3 hours at 15°C to 25°C
8 hours at 2°C to 8°C
2 weeks at -25°C to -15°C
Total Bilirubin
6 hours at 15°C to 25°C
1 day at 2°C to 8°C

G. CONTROLS

.

:

| Analytes | Already cleared
(K052007, K060205, K060318,
K060325, K060854, K062180,
K062737, K060434, K072115,
K110137, K110530) | Included in this submission |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Alkaline phosphatase | √ | √ |
| Alanine aminotransferase | √ | √ |
| Amylase | √ | √ |
| Aspartate aminotransferase | √ | √ |
| Creatine kinase | √ | √ |
| GGT | √ | √ |
| LDH | √ | √ |
| Lipase | √ | √ |

・

HORIBA ABX SAS, FRANCE

.

:

16

ABX PENTRA N Control:
Albumin	√	√
Direct Bilirubin	√	√
Total Bilirubin	√	√
Calcium	√	√
New Calcium AS		√
Chloride	√	√
Cholesterol	√	√
HDL	√	√
LDL	√	√
Creatinine 120	√	√
Enzymatic Creatinine CP	√	√
Glucose HK	√	√
Glucose PAP	√	√
Iron	√	√
Lactic acid	√	√
Magnesium	√	√
Phosphorus	√	√
Potassium	√	√
Sodium	√	√
Total Protein	√	√
Total Protein 100	√	√
Triglycerides	√	√
Urea / Blood Urea Nitrogen	√	√
Uric acid	√	√

.../...

Format	Lyophilized human serum with chemical additives and materials of biological origin
Stability	Closed stability: 30 months at 2-8°C
	Open stability:
	Once opened, the control components** are stable for:
	12 hours at 15°C to 25°C
	5 days at 2°C to 8°C
	1 month at -25°C to -15°C
	**Exceptions
	Direct Bilirubin
	4 hours at 15°C to 25°C
	8 hours at 2°C to 8°C
	2 weeks at -25°C to -15°C
	Total Bilirubin
	8 hours at 15°C to 25°C
	1 day at 2°C to 8°C
	2 weeks at -25°C to -15°C

.

HORIBA ABX SAS, FRANCE

17

ABX PENTRA P Control:
Analytes	Already cleared
(K052007, K060205, K060318,
K060325, K060854, K062180,
K062737, K060434, K072115,
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		√
Chloride	√	√
Cholesterol	√	√
HDL	√	√
LDL	√	√
Creatinine 120	√	√
Enzymatic Creatinine CP	√	√
Glucose HK	√	√
Glucose PAP	√	√
Iron	√	√
Lactic acid	√	√
Magnesium	√	√
Phosphorus	√	√
Potassium	√	√
Sodium	√	√
Total Protein	√	√
Total Protein 100	√	√
Triglycerides	√	√
Urea / Blood Urea Nitrogen	√	√
Uric acid	√	√
Format	Lyophilized human serum with chemical additives and material
of biological origin
Stability	Closed stability: 30 months at 2-8°C
Open stability:
Once opened, the control components** are stable for :
12 hours at 15°C to 25°C
	ABX PENTRA P Control:
	1 month at -25°C to -15°C	.../...
	**Exceptions
	Direct Bilirubin
	4 hours at 15°C to 25°C
	8 hours at 2°C to 8°C
	2 weeks at -25°C to -15°C
	Total Bilirubin
	8 hours at 15°C to 25°C
	1 day at 2°C to 8°C
	2 weeks at -25°C to -15°C.

. HORIBA ABX SAS, FRANCE

:

.

:

.

18

ABX PENTRA Urine Control L/H:
Analytes	Already cleared (K07249,
K072115, K110137, K110530)	Included in this submission
Amylase	√	√
Calcium	√	√
New Calcium AS		√
Creatinine 120	√	√
Enzymatic Creatinine CP	√	√
Phosphorus	√	√
Glucose	√	√
Urea / Blood Urea Nitrogen	√	√
Uric acid	√	√
Urinary proteins	√	√
Format
Stability	Liquid solution prepared from human urine with chemical
additives and materials of biological origin
Closed stability: 2 years at 2-8°C
Open stability: 30 days at 2-8°C

. Conclusions for Performance Testing:

11.11

The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices. : .

.

· ·

.

19

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/19/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wave-like lines beneath it.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 3, 2013

Horiba ABX SAS C/O Caroline Ferrer Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE

Re: K123171

Trade/Device Name: ABX PENTRA CALCIUM AS CP, ABX PENTRA Multical, ABX PENTRA N Control, ABX PENTRA P Control, ABX PENTRA Urine Control L/H

Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: II Product Code: CJY, JIX, JJY Dated: May 17, 2013 Received: May 20, 2013

Dear Ms. Ferrer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

20

Page 2-Ms. Ferrer

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

21

510(k) Number (if known): K123171

Device Name: ABX Pentra Calcium AS CP

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).

Prescription Use _ X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung W. Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123171

22

510(k) Number (if known): K123171

Device Name: ABX PENTRA Multical

Indications for Use:

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical clinical chemistry analyzers.

Prescription Use _X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung W. Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123171

Page 2 of 5

23

510(k) Number (if known): K123171

Device Name: ABX PENTRA N Control

Indications for Use:

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.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

YungW.Chan-S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)_k123171

Page 3 of 5

24

510(k) Number (if known): K123171

Device Name: ABX PENTRA P Control

Indications for Use:

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.

Prescription Use _ X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

YungW.Chan-s

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) = K123171

25

510(k) Number (if known): K123171

Device Name: ABX PENTRA Urine Control L/H .

Indications for Use:

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.

Prescription Use _ X (21 CFR Part 801 Subpart D)

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung W. Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K123171 510(k)