General Chemistries reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.

ABX PENTRA ALP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

ABX PENTRA Calcium CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of calcium in human serum and plasma based on a photometric test using orthocresolphtalein complexone. 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).

ABX PENTRA CO2 RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of carbon dioxide in human serum and plasma based on an enzymatic test using phosphoenolpyruvate (PEP), phosphorenolpyruvate carboxylase (PEPC) and an analog of NADH. Bicarbonate/carbon measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

ABX PENTRA Creatinine CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of creatinine in human serum and plasma based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

ABX PENTRA Iron CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of iron (non-heme) in human serum and plasma based on a photometric test (Ferene method). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and hemochromatosis.

ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of phosphorus in human serum and plasma based on a UV method using phosphomolybdate. Measurement of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

ABX PENTRA Urea CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of urea nitrogen (an end-product of nitrogen metabolism) in human serum and plasma based on an enzymatic UV test using urease and glutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of uric acid in human serum and plasma based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

The ABX PENTRA CO2 Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CO2 RTU method on Horiba ABX clinical chemistry analyzers as specified on the vial.

The ABX PENTRA CO₂ Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CO2 RTU method as specified in the enclosed annex.

Device Description

All the reagents, controls and calibrators 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 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).

All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Horiba ABX PENTRA reagents, controls, and calibrators, based on the provided 510(k) summary:

This submission is for multiple reagents, controls, and calibrators for the ABX PENTRA 400 clinical chemistry analyzer. The performance data is presented for each reagent individually. The acceptance criteria and reported performance will be summarized for each reagent as presented in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the reported performance, which demonstrates that the devices "met all acceptance criteria" and are "substantially equivalent" to their respective predicate devices. Specific quantitative acceptance criteria are not explicitly stated as separate targets but are shown by the achieved performance values.

ABX PENTRA ALP CP (Alkaline phosphatase)

Acceptance Criteria (Implied)	Reported Device Performance
Detection limit met	6 U/l
Accuracy and Precision met	CV Total < 4.36%
Measuring range met	6 U/l – 1500 U/l (Automatic post-dilution: 6000 U/l)
Correlation met	Y = 1.07 x - 3.93 with r² = 0.998
Calibration stability met	7 hours
Reagent stability met	closed: 18 months at 2-8°C, on-board: 29 days

ABX PENTRA Calcium CP (Calcium)

Acceptance Criteria (Implied)	Reported Device Performance
Detection limit met	0.16 mg/dl
Accuracy and Precision met	CV Total < 1.67%
Measuring range met	0.16 mg/dl – 20.1 mg/dl (Automatic post-dilution: 40.2 mg/dl)
Correlation met	Y = 1.15 x - 1.12 with r² = 0.950
Calibration stability met	6 hours
Reagent stability met	closed: 24 months at 2-8°C, on-board: 14 days

ABX PENTRA CO2 RTU (Carbon Dioxide)

Acceptance Criteria (Implied)	Reported Device Performance
Detection limit met	1.8 mmol/l
Accuracy and Precision met	CV Total < 7.7%
Measuring range met	1.8 mmol/l - 60.8 mmol/l (Automatic post-dilution: 121.6 mmol/l)
Correlation met	Y = 0.85 x + 0.3 with r² = 0.976
Calibration stability met	1 day
Reagent stability met	closed: 16 months at 2-8°C, on-board: 28 days

ABX PENTRA Creatinine CP (Creatinine)

Acceptance Criteria (Implied)	Reported Device Performance
Detection limit met	0.11 mg/dl
Accuracy and Precision met	CV Total < 3.69%
Measuring range met	0.11 mg/dl - 15.8 mg/dl (Automatic post-dilution: 79 mg/dl)
Correlation met	Y = 0.96 x - 0.12 with r² = 0.996
Calibration stability met	1 day
Reagent stability met	closed: 36 months at 2-8°C, on-board: 7 days

ABX PENTRA Iron CP (Iron)

Acceptance Criteria (Implied)	Reported Device Performance
Detection limit met	7.42 µg/dl
Accuracy and Precision met	CV Total < 3.61%
Measuring range met	7.42 µg/dl – 1004 µg/dl (Automatic post-dilution: 5020 µg/dl)
Correlation met	Y = 1.13 x + 5.30 with r² = 0.997
Calibration stability met	8 days
Reagent stability met	closed: 24 months at 2-8°C, on-board: 41 days

ABX PENTRA Magnesium RTU (Magnesium)

Acceptance Criteria (Implied)	Reported Device Performance
Detection limit met	0.17 mg/dl
Accuracy and Precision met	CV Total < 3.19%
Measuring range met	0.17 mg/dl - 4.64 mg/dl (Automatic post-dilution: 13.92 mg/dl)
Correlation met	Y = 1.23 x - 0.24 with r² = 0.971
Calibration stability met	2 days
Reagent stability met	closed: 24 months at 2-8°C, on-board: 7 days

ABX PENTRA Phosphorus CP (Phosphorus)

Acceptance Criteria (Implied)	Reported Device Performance
Detection limit met	0.28 mg/dl
Accuracy and Precision met	CV Total < 3.56%
Measuring range met	0.28 mg/dl – 24.18 mg/dl (Automatic post-dilution: 96.72 mg/dl)
Correlation met	Y = 1.04 x + 0.19 with r² = 0.997
Calibration stability met	34 days
Reagent stability met	closed: 36 months at 2-8°C, on-board: 34 days

ABX PENTRA Urea CP (Urea)

Acceptance Criteria (Implied)	Reported Device Performance
Detection limit met	Urea: 1.86 mg/dl, BUN: 0.9 mg/dl
Accuracy and Precision met	CV Total < 2.76%
Measuring range met	Urea: 1.86 - 300 mg/dl (Auto post-dilution: 1500 mg/dl); BUN: 0.9 - 140.3 mg/dl (Auto post-dilution: 701.5 mg/dl)
Correlation met	Urea: Y = 1.01 x + 1.80 with r² = 0.9905; BUN: Y = 1.01 x + 0.81 with r² = 0.9905
Calibration stability met	8 days
Reagent stability met	closed: 24 months at 2-8°C, on-board: 70 days

ABX PENTRA Uric Acid CP (Uric Acid)

Acceptance Criteria (Implied)	Reported Device Performance
Detection limit met	0.19 mg/dl
Accuracy and Precision met	CV Total < 2.81%
Measuring range met	0.19 mg/dl - 25 mg/dl (Automatic post-dilution: 75 mg/dl)
Correlation met	Y = 0.97 x - 0.13 with r² = 0.958
Calibration stability met	15 days
Reagent stability met	closed: 36 months at 2-8°C, on-board: 41 days

Controls and Calibrators Stability

Product	Acceptance Criteria (Implied)	Reported Device Performance
ABX PENTRA CO2 Cal	Stability met	closed: 15 months at 2-25°C, open: 3 months at 2-25°C
ABX PENTRA Multical	Stability met	closed: 24 months at 2-8°C, open: 8 hours at 15-25°C, 2 days at 2-8°C, 2 weeks at -25-(-15)°C (with exceptions for Bilirubins)
ABX PENTRA CO2 Control	Stability met	closed: 15 months at 2-25°C, open: 3 months at 2-25°C
ABX PENTRA N Control	Stability met	closed: 30 months at 2-8°C, open: 12 hours at 15-25°C, 5 days at 2-8°C, 1 month at -25-(-15)°C (with exceptions for Bilirubins)
ABX PENTRA P Control	Stability met	closed: 30 months at 2-8°C, open: 12 hours at 15-25°C, 5 days at 2-8°C, 1 month at -25-(-15)°C (with exceptions for Bilirubins)

2. Sample Sizes Used for the Test Set and Data Provenance

The sample sizes for the correlation studies (which serve as the primary test set for comparing to predicate devices) are as follows:

ABX PENTRA ALP CP: n=105
ABX PENTRA Calcium CP: n=95
ABX PENTRA CO2 RTU: n=97
ABX PENTRA Creatinine CP: n=95
ABX PENTRA Iron CP: n=98
ABX PENTRA Magnesium RTU: n=75
ABX PENTRA Phosphorus CP: n=105
ABX PENTRA Urea CP: n=108
ABX PENTRA Uric Acid CP: n=98

The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the provided summary. However, the company is based in France and the submission is for the US market. The samples are described generally as "human serum and plasma".

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable as the devices are in vitro diagnostic reagents for quantitative measurement, not diagnostic imaging devices requiring expert interpretation for ground truth. The "ground truth" for correlation studies would typically be the results obtained from a legally marketed predicate device or a reference method.

4. Adjudication Method for the Test Set

This is not applicable for this type of in vitro diagnostic device study. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments.

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the devices are in vitro diagnostic reagents and not AI-powered diagnostic tools for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The entire performance data presented is for the standalone (algorithm only) performance of the reagents when used with the ABX PENTRA 400 analyzer. There is no human-in-the-loop component for these quantitative chemistry measurements.

7. The type of ground truth used

The "ground truth" for the performance studies, particularly the correlation data, is implicitly established by comparison to results from legally marketed predicate devices or established reference methods. This is indicated by the statement of "substantial equivalence" to named predicate devices and the correlation data that compares the results of the new device (Y) to an existing method (x).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. For in vitro diagnostic devices like these, method development and optimization would precede the validation studies, but a distinct "training set" as understood in AI is not typically a component of the regulatory submission for this type of product. The performance data presented are for the validation of the finalized method.

9. How the Ground Truth for the Training Set Was Established

Given that a "training set" in the AI sense is not explicitly mentioned or applicable for these devices, the question of how its ground truth was established is not applicable. The development of the reagents involves standard chemical and analytical validation processes to ensure accuracy and precision, typically against reference standards and established methods, often during an internal R&D phase.

Summary

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Premarket Notification [510(k)] Summary

JUL 2 1 2006

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

K060205 The assigned 510(k) number is : _

Company: Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 73 20 + (33) 4 67 14 15 17 Fax:

Contact Person: Tim Lawton (tlawton@fr.abx.fr)

Date Prepared: 20th January 2006

Device Names:

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

REAGENTS :

Trade/Proprietary Name:	ABX PENTRA ALP CP
Common or Usual Name:	ALP - Alkaline phosphatase
Device Class	Class II
Classification Name:	§862.1050 : Alkaline phosphatase Test System
Product Code:	CJE ; nitrophenylphosphate, alkaline phosphatase or isoenzymes
Trade/Proprietary Name:	ABX PENTRA Calcium CP
Common or Usual Name:	Calcium
Device Class	Class II
Classification Name:	§862.1145 : Calcium Test System
Product Code:	CIC ; cresolphthalein complexone, calcium
Trade/Proprietary Name:	ABX PENTRA CO2 RTU
Common or Usual Name:	carbon dioxide
Device Class	Class II
Classification Name:	§862.1160 : Bicarbonate/carbon dioxide Test System
Product Code:	KHS ; enzymatic, carbon-dioxide

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

Trade/Proprietary Name:

Common or Usual Name: Device Class Classification Name: Product Code:

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 Creatinine CP

Creatinine Class II §862.1225 : Creatinine Test System CGX : alkaline picrate, colorimetry, creatinine

ABX PENTRA Iron CP

Iron Class I §862.1410 : Iron (non-heme) Test System JIY ; photometric method, iron (non-heme)

ABX PENTRA Magnesium RTU

Magnesium Class II §862.1495 : Magnesium Test System JGJ ; photometric method, magnesium

ABX PENTRA Phosphorus CP

Phosphorus Class II &862.1580 : Phosphorus (inorganic) Test System CEO : phosphomolybdate (colorimetric), inorganic phosphorus

ABX PENTRA Urea CP

Urea Class II &862.1770 : Urea nitrogen Test System CDQ ; urease and glutamic dehydrogenase, urea nitrogen

ABX PENTRA Uric Acid CP

Uric Acid Class I §862.1775 : Uric acid Test System KNK ; acid, uric, uricase (colorimetric)

ABX PENTRA CO2 Control

CO2 Control Class I §862.1660 : Quality control material (assayed and unassayed) JJX ; single (specified) analyte controls (assayed and unassayed)

ABX PENTRA N Control (K052007)

N Control Class I §862.1660 : Quality control material (assayed and unassayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

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

Calibrators :

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

Common or Usual Name:

Classification Name:

Device Class

Product Code:

ABX PENTRA P Control (K052007)

P Control Class I §862.1660 : Quality control material (assayed and unassayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

ABX PENTRA Multical (K052007)

Multical Class II $862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture

Trade/Proprietary Name: ABX PENTRA CO2 Cal

CO2 Calibrator Class II 8862.1150 : Calibrator JIT ; calibrator, secondary

Substantial Equivalence:

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

Submission device	Substantially equivalentpredicate device
ABX PENTRA ALP CP	K801242
ABX PENTRA Calcium CP	K883453
ABX PENTRA CO2 RTU	K031879
ABX PENTRA Creatinine CP	K941837
ABX PENTRA Iron CP	K864819
ABX PENTRA Magnesium RTU	K901758
ABX PENTRA Phosphorus CP	K883962
ABX PENTRA Urea CP	K954000
ABX PENTRA Uric Acid CP	K922762
ABX PENTRA CO2 Cal	K031879
ABX PENTRA CO2 Control	K891475

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Description:

All the reagents, controls and calibrators 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 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).

All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters

Intended Use :

All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of their respective analytes (ALP - Alkaline Phosphatase, Calcium, C02, Creatinine, Iron, Magnesium, Phosphorus, Urea / Blood Urea Nitrogen, Uric Acid) using human serum and plasma.

The controls and calibrators are intended for use in association with the above reagents.

Discussion of Performance Data:
---------------------------------	--

ABX PENTRA ALP CP :
Sample type	Serum & plasma
Detection limit	6 U/l
Accuracy and Precision	CV Total < 4.36%
Measuring range	6 U/l – 1500 U/lAutomatic post-dilution : 6000 U/l
Correlation (n=105)	Y = 1.07 x - 3.93 with a correlation coefficient r² = 0.998.
Calibration stability	7 hours
Reagent stability	closed stability: 18 months at 2-8°Con-board stability (refrigerated area): 29 days

ABX PENTRA Calcium CP :
Sample type	Serum & plasma
Detection limit	0.16 mg/dl
Accuracy and Precision	CV Total < 1.67%

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ABX PENTRA Calcium CP :
Measuring range	0.16 mg/dl – 20.1 mg/dlAutomatic post-dilution : 40.2 mg/dl
Correlation (n=95)	$Y = 1.15 x - 1.12$ with a correlation coefficient $r^2 = 0.950$ .
Calibration stability	6 hours
Reagent stability	closed stability: 24 months at 2-8°Con-board stability (refrigerated area): 14 days

ABX PENTRA CO₂ RTU:
Sample type	Serum & plasma
Detection limit	1.8 mmol/l
Accuracy and Precision	CV Total < 7.7%
Measuring range	1.8 mmol/l - 60.8 mmol/lAutomatic post-dilution : 121.6 mmol/l
Correlation (n=97)	$Y = 0.85 x + 0.3$ with a correlation coefficient $r^2 = 0.976$ .
Calibration stability	1 day
Reagent stability	closed stability: 16 months at 2-8°Con-board stability (refrigerated area): 28 days

ABX PENTRA Creatinine CP :
Sample type	Serum & plasma
Detection limit	0.11 mg/dl
Accuracy and Precision	CV Total < 3.69%
Measuring range	0.11 mg/dl - 15.8 mg/dlAutomatic post-dilution : 79 mg/dl
Correlation (n=95)	$Y = 0.96 x - 0.12$ with a correlation coefficient r2 = 0.996.
Calibration stability	1 day
Reagent stability	closed stability: 36 months at 2-8°Con-board stability (refrigerated area): 7 days

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ABX PENTRA Iron CP :
Sample type	Serum & plasma
Detection limit	7.42 µg/dl
Accuracy and Precision	CV Total < 3.61%
Measuring range	7.42 µg/dl – 1004 µg/dlAutomatic post-dilution : 5020 µg/dl
Correlation (n=98)	Y = 1.13 x + 5.30 with a correlation coefficient r² = 0.997.
Calibration stability	8 days
Reagent stability	closed stability: 24 months at 2-8°Con-board stability (refrigerated area): 41 days

ABX PENTRA Magnesium RTU :
Sample type	Serum & plasma
Detection limit	0.17 mg/dl
Accuracy and Precision	CV Total < 3.19%
Measuring range	0.17 mg/dl - 4.64 mg/dlAutomatic post-dilution : 13.92 mg/dl
Correlation (n=75)	Y = 1.23 x - 0.24 with a correlation coefficient r² = 0.971.
Calibration stability	2 days
Reagent stability	closed stability: 24 months at 2-8°Con-board stability (refrigerated area): 7 days

ABX PENTRA Phosphorus CP :
Sample type	Serum & plasma
Detection limit	0.28 mg/dl
Accuracy and Precision	CV Total < 3.56%
Measuring range	0.28 mg/dl – 24.18 mg/dlAutomatic post-dilution : 96.72 mg/dl
Correlation (n=105)	Y = 1.04 x + 0.19 with a correlation coefficient r² = 0.997.

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ABX PENTRA Phosphorus CP :
Calibration stability	34 days
Reagent stability	closed stability: 36 months at 2-8°Con-board stability (refrigerated area): 34 days

ABX PENTRA Urea CP :
Sample type	Serum & plasma
Detection limit	Urea: 1.86 mg/dlBUN: 0.9 mg/dl
Accuracy and Precision	CV Total < 2.76%
Measuring range	Urea : 1.86 mg/dl - 300 mg/dlAutomatic post-dilution: 1500 mg/dlBUN: 0.9 mg/dl - 140.3 mg/dlAutomatic post-dilution : 701.5 mg/dl
Correlation (n=108)	Urea: Y = 1.01 x + 1.80 with a correlation coefficient r² = 0.9905.BUN: Y = 1.01 x + 0.81 with a correlation coefficient r² = 0.9905.
Calibration stability	8 days
Reagent stability	closed stability: 24 months at 2-8°Con-board stability (refrigerated area): 70 days

ABX PENTRA Uric Acid CP :
Sample type	Serum & plasma
Detection limit	0.19 mg/dl
Accuracy and Precision	CV Total < 2.81%
Measuring range	0.19 mg/dl - 25 mg/dlAutomatic post-dilution : 75 mg/dl
Correlation (n=98)	Y = 0.97 x - 0.13 with a correlation coefficient r² = 0.958.
Calibration stability	15 days
Reagent stability	closed stability: 36 months at 2-8°Con-board stability (refrigerated area): 41 days

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CALIBRATORS

ABX PENTRA CO2 Cal:
Stability	closed stability: 15 months at 2-25°Copen stability: 3 months at 2-25°C

ABX PENTRA Multical:
Stability	Closed stability: 24 months at 2-8°COpen stability:Once opened, the calibrator components* are stable for :8 hours at 15°C to 25°C2 days at 2°C to 8°C2 weeks at -25°C to -15°C*ExceptionsDirect Bilirubin3 hours at 15°C to 25°C8 hours at 2°C to 8°C2 weeks at -25°C to -15°CTotal Bilirubin6 hours at 15°C to 25°C1 day at 2°C to 8°C2 weeks at -25°C to -15°C

CONTROLS

ABX PENTRA CO2 Control:
Stability
	Closed stability: 15 months at 2-25°COpen stability: 3 months at 2-25°C

ABX PENTRA N Control:
Stability	Closed stability: 30 months at 2-8°COpen stability:Once opened, the control components* are stable for :12 hours at 15°C to 25°C5 days at 2°C to 8°C1 month at -25°C to -15°C*ExceptionsDirect Bilirubin4 hours at 15°C to 25°C8 hours at 2°C to 8°C2 weeks at -25°C to -15°C

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ABX PENTRA N Control:
	Total Bilirubin8 hours at 15°C to 25°C1 day at 2°C to 8°C2 weeks at -25°C to -15°C

ABX PENTRA P Control:
Stability	Closed stability: 30 months at 2-8°COpen stability:Once opened, the control components* are stable for :12 hours at 15°C to 25°C5 days at 2°C to 8°C1 month at -25°C to -15°C*ExceptionsDirect Bilirubin4 hours at 15°C to 25°C8 hours at 2°C to 8°C2 weeks at -25°C to -15°CTotal Bilirubin8 hours at 15°C to 25°C1 day at 2°C to 8°C2 weeks at -25°C to -15°C

Conclusions for Performance Testing :

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, clutching a staff with a snake wrapped around it.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Tim Lawton Regulatory Affairs Manager Horiba ABX Parc Euromèdecine Rue du Caducèe- BP 7290 34184 Montpellier cedex 4- France

Re: K060205

Trade/Device Name: General Chemistries on ABX PENTRA 400 Clinical Chemistry Analyzer ABX PENTRA CO2 Cal ABX PENTRA CO2 Control Regulation Number: 21 CFR$ 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system

Regulatory Class: Class II Product Code: CJE, CIC, KHS, CGX, JIY, JGJ, CEO, CDQ, KNK, JJX, JJY, JIX, JJT Dated: June 28, 2006 Received: June 30, 2006

JUL 2 1 2006

Dear Mr. Lawton:

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.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 vour 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G.

Alberto Gutierrez, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: General Chemistries on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

General Chemistries reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Number (if known): کرک(کی) کا کا

Device Name: General Chemistries on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. "Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of of An Vitko Diagnostic Diagnostic Devices (OIVD)

Office of In Vitro Diagnostic Devia
Evatud Saferv

KUL 0705

Page 2 of 5

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510(k) Number (if known):

Device Name: General Chemistries on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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DIVISION SIGN-OFF

Page 3 of _

Office of In Viter Disgnostic Device Evaluation and Safety

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510(k) Number (if known): ΚΟύ Ολυ Συν

Device Name: ABX PENTRA CO2 Cal

Indications For Use:

The ABX PENTRA CO2 Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CO2 RTU method on Horiba ABX clinical chemistry analyzers as specified on the vial.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Office of In V. Diagnostic Device Evaluation and Safety	Page 4 of 5
KOLCZUJ

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510(k) Number (if known):

Device Name: ABX PENTRA CO2 Control

Indications For Use:

The ABX PENTRA CO₂ Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CO2 RTU method as specified in the enclosed annex.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

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Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of	5
510(k)	K060205

Regulation Number and Section

§ 862.1050 Alkaline phosphatase or isoenzymes test system.

(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.