Proteins 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 Albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry.

Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

ABX PENTRA Total Protein CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.

Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

ABX PENTRA Micro-albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Albumin in urine (µALB) at low concentration by immunoturbidimetric assay.

Measurements of albumin aids in the diagnosis of diabetic nephritis and other kidney and intestinal diseases.

The ABX PENTRA µ-Alb Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Micro-albumin CP method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA u-Alb Control L/H is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA Micro-albumin CP method.

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

The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

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 Albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum and plasma based on a colorimetric test using Bromocresol Green (BCG). It is composed of a 99 ml mono-reagent cassette.

The ABX PENTRA Total Protein CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 61 ml mono-reagent cassette.

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

The ABX PENTRA Micro-albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human urine based on an immunoturbidimetric test. It is composed of a bi-reagent cassette, with 19 ml and 4.5 ml compartments.

The ABX PENTRA u-Alb Cal is a liquid calibrator prepared by adding purified human albumin to a chemical buffer solution. It has 5 levels to be used for the calibration of the urinary albumin assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.

The ABX PENTRA u-Alb Control L/H is a liguid assayed control prepared by adding purified human albumin to a chemical buffer solution. It has 2 levels (Low and High) to be used for the quality control of the urinary albumin assay. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 1 ml.

AI/ML Overview

The provided text describes performance data for a set of reagents, controls, and calibrators used with the ABX PENTRA 400 clinical chemistry analyzer. The studies conducted are in vitro diagnostic assay performance evaluations, not studies involving human readers or clinical outcomes in the same way an AI-powered diagnostic device would be evaluated. As such, several requested items (MRMC study, expert ground truth, adjudication methods) are not applicable to this type of submission.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The provided tables summarize the performance characteristics. The document states that "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." While specific numeric acceptance criteria for each metric (e.g., "CV Total must be < X%") are not explicitly listed, the "Reported Device Performance" column represents the results achieved, which are implied to have met the predefined criteria for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Device/Metric	Acceptance Criteria (Implied)	Reported Device Performance
ABX PENTRA Albumin CP	-	Sample type: Serum & plasmaDetection limit: 0.02 g/dlAccuracy and Precision: CV Total < 1.86%Measuring range: 0.46 g/dl – 5.60 g/dlUpper linearity limit: 5.60 g/dl, with automatic post-dilution: 11.20 g/dlCorrelation (n=272): Y = 0.94 x + 0.01 with r² = 0.9864Calibration stability: 14 daysReagent stability: closed 36 months (2-8°C), on-board 83 days (refrigerated area)
ABX PENTRA Micro-albumin CP	-	Sample type: UrineDetection limit: 4 mg/lAccuracy and Precision: CV Total < 7.99%Measuring range: 9.0 mg/l – 200 mg/lUpper linearity limit: 200 mg/l, with automatic post-dilution: 2000 mg/lCorrelation (n=252): Y = 0.91 x + 3.95 with r² = 0.9919Calibration stability: 7 daysReagent stability: closed 24 months (2-8°C), on-board 23 days (refrigerated area)
ABX PENTRA Total Protein CP	-	Sample type: Serum & plasmaDetection limit: 0.14 g/dlQuantitation limit: 0.60 g/dlAccuracy and Precision: CV Total < 2.82%Measuring range: 0.60 g/dl - 10 g/dlUpper linearity limit: 10 g/dl, with automatic post-dilution: 20 g/dlCorrelation: Serum (n=230): Y = 1.03 x + 0.02 with r² = 0.9841. Plasma (n=262): Y = 0.98 x - 0.02 with r² = 0.9815.Calibration stability: 1 dayReagent stability: closed 36 months (2-8°C), on-board 6 days (refrigerated area)
ABX PENTRA µ-Alb Cal	-	Analyte: AlbuminFormat: Purified human albumin added to a chemical buffer solutionStability: Closed 12 months (2-10°C), Open 4 weeks (2-10°C), 3 months (-20°C)
ABX PENTRA Multical	-	Analytes: Various (as listed)Format: Lyophilized human serum with chemical additives and materials of biological originStability: Closed 24 months (2-8°C), Open: 8h (15-25°C), 2 days (2-8°C), 2 weeks (-25 to -15°C) (exceptions for Direct/Total Bilirubin)
ABX PENTRA µ-Alb Control	-	Analyte: AlbuminFormat: Purified human albumin added to a chemical buffer solutionStability: Closed 12 months (2-10°C), Open 4 weeks (2-10°C)
ABX PENTRA N Control	-	Analytes: Various (as listed)Format: Lyophilized human serum with chemical additives and materials of biological originStability: Closed 30 months (2-8°C), Open: 12h (15-25°C), 5 days (2-8°C), 1 month (-25 to -15°C) (exceptions for Direct/Total Bilirubin)
ABX PENTRA P Control	-	Analytes: Various (as listed)Format: Lyophilized human serum with chemical additives and materials of biological originStability: Closed 30 months (2-8°C), Open: 12h (15-25°C), 5 days (2-8°C), 1 month (-25 to -15°C) (exceptions for Direct/Total Bilirubin)

(Note: "Acceptance Criteria (Implied)" is marked as '-' because specific target values for each metric were not explicitly stated in the provided text, only that the reported performance "met all acceptance criteria.")

2. Sample size used for the test set and the data provenance:

ABX PENTRA Albumin CP:
- Test Set Sample Size: n=272 for correlation study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Standard in vitro diagnostic assay validation typically uses a mix of native human samples, spiked samples, and control materials.
ABX PENTRA Micro-albumin CP:
- Test Set Sample Size: n=252 for correlation study.
- Data Provenance: Not explicitly stated.
ABX PENTRA Total Protein CP:
- Test Set Sample Size: n=230 for serum samples and n=262 for plasma samples in correlation studies.
- Data Provenance: Not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not an imaging or diagnostic AI device requiring expert interpretation of clinical data for ground truth. The "ground truth" for these assays would typically be established by reference methods or validated comparative methods, and the accuracy evaluated against those.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. As per point 3, there is no expert adjudication process involved for establishing ground truth in this type of in vitro assay performance study.

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:

Not Applicable. This is not an AI/human-in-the-loop diagnostic device but a chemical analyzer with associated reagents, controls, and calibrators.

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

Yes, effectively. The performance data presented (accuracy, precision, linearity, stability, correlation) are for the device (reagent/analyzer system) operating in a standalone analytical capacity. The "performance data" discussed are the results generated solely by the ABX PENTRA 400 system using these components.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the correlation studies ("Y = ... x + ... with a correlation coefficient r² = ..."), the device's measurements (Y) are being correlated against measurements from another method (x), which serves as the comparative or "ground truth" method. The text does not explicitly name the specific comparative methods used for albumin, micro-albumin, and total protein but relies on the concept of "substantial equivalence" to predicate devices, implying these predicate devices' methods serve as the benchmark. Precision, linearity, and stability are evaluated intrinsically against standardized methods and statistical metrics.

8. The sample size for the training set:

Not Applicable in the context of machine learning. These are chemical assays, not machine learning algorithms that require explicit "training sets" in the modern AI sense. The development of such assays involves formulation optimization and internal validation, which could be considered analogous, but the term "training set" doesn't directly apply.

9. How the ground truth for the training set was established:

Not Applicable. See point 8. The "ground truth" for developing and validating these types of assays involves adherence to established chemical principles, analytical standards, and comparison to validated reference measurement procedures or existing, legally marketed predicate devices.

Summary

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JUN - 5 2007

Premarket Notification [510(k)] Summary

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 : K060434

Company: Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 15 03 Fax: + (33) 4 67 14 15 17

Contact Person: Pascal Macziola (pmacziola(a)fr.abx.fr)

Date Prepared: 11th April 2007

Device Names:

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

REAGENTS :

Device Class

Product Code:

Classification Name:

ABX PENTRA Albumin CP

Albumin Class II §862.1035 : Albumin Test System CIX ; Bromcresol Green Dye-Binding, Albumin

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

Trade/Proprietary Name: Common or Usual Name:

ABX PENTRA Micro-albumin CP

Micro-albumin Class I §866.5040 : Albumin immunological Test System DCF ; Albumin, Antigen, Antiserum, Control

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

ABX PENTRA Total Protein CP

Total Protein Class II §862.1635 : Total Protein Test System CEK ; Biuret (colorimetric), Total Protein

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

CALIBRATORS:

ABX PENTRA p-Alb Cal

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

u-Alb Cal Class II $862.1150 : Calibrator JIT ; Calibrator, Secondary

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

Trade/Proprietary Name: Common or Usual Name:

ABX PENTRA Multical (K052007) Multical

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

CONTROLS :

Device Class

Product Code:

Classification Name:

ABX PENTRA u-Alb Control L/H u-Alb Control L/H Class I §862.1660 : Quality control material (assayed) JJX ; Single (Specified) Analyte Controls, assayed

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

ABX PENTRA N Control (K052007) N Control

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

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

ABX PENTRA P Control (K052007)

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

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 Albumin CP	K896235
ABX PENTRA Micro-albumin CP	K903123
ABX PENTRA Total Protein CP	K896230

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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.

HORIBA ABX, FRANCE

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

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 :

Albumin using human serum and plasma,
Micro-albumin using urine,
Total Protein 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 Albumin CP :
Sample type	Serum & plasma
Detection limit	0.02 g/dl
Accuracy and Precision	CV Total < 1.86%
Measuring range	0.46 g/dl – 5.60 g/dl
Upper linearity limit	5.60 g/dl, and with automatic post-dilution : 11.20 g/dl
Correlation (n=272)	$Y = 0.94 x + 0.01$ with a correlation coefficient $r^2 = 0.9864$ .
Calibration stability	14 days
Reagent stability	closed stability: 36 months at 2-8°Con-board stability (refrigerated area): 83 days

ABX PENTRA Micro-albumin CP :
Sample type	Urine
Detection limit	4 mg/l
Accuracy and Precision	CV Total < 7.99%
Measuring range	9.0 mg/l – 200 mg/l
Upper linearity limit	200 mg/l, and with automatic post-dilution : 2000 mg/l
Correlation (n=252)	Y = 0.91 x + 3.95 with a correlation coefficient r² = 0.9919.
Calibration stability	7 days
Reagent stability	closed stability: 24 months at 2-8°Con-board stability (refrigerated area): 23 days

HORIBA ABX, FRANCE

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ABX PENTRA Total Protein CP :
Sample type	Serum & plasma
Detection limitQuantitation limit	0.14 g/dl0.60 g/dl
Accuracy and Precision	CV Total < 2.82%
Measuring range	0.60 g/dl - 10 g/dl
Upper linearity limit	10 g/dl, and with automatic post-dilution : 20 g/dl
Correlation	Serum samples (n=230) :Y = 1.03 x + 0.02 with a correlation coefficient r² = 0.9841.Plasma samples (n=262) :Y = 0.98 x - 0.02 with a correlation coefficient r² = 0.9815.
Calibration stability	1 day
Reagent stability	closed stability: 36 months at 2-8°Con-board stability (refrigerated area): 6 days

CALIBRATORS

ABX PENTRA µ-Alb Cal:
Analyte	Albumin
Format	Purified human albumin added to a chemical buffer solution
Stability	Closed stability: 12 months at 2°C to 10°COpen stability:4 weeks at 2°C to 10°C3 months at -20°C

and the country of the county of

HORIBA ABX, FRANCE

Section 5-5

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ABX PENTRA Multical:
Analytes	Already cleared (K052007,K060205, K060318, K060325,K060854, K062180)	Included in this submission
Alkaline phosphatase	√	√
Alanine aminotransferase	√	√
Amylase	√	√
Aspartate aminotransferase	√	√
Creatine kinase*
GGT	√	√
Lipase	√	√
Albumin		√
Direct Bilirubin	√	√
Total Bilirubin	√	√
Calcium	√	√
Cholesterol	√	√
Creatinine	√	√
Glucose HK	√	√
Glucose PAP	√	√
Iron	√	√
Lactic acid	√	√
Magnesium	√	√
Phosphorus	√	√
Total Protein		√
Triglycerides	√	√
Urea / Blood Urea Nitrogen	√	√
Uric acid	√	√
Format	Lyophilized human serum with chemical additives and materialsof biological origin
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**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
	2 weeks at -25°C to -15°C

HORIBA ABX, FRANCE

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

CONTROLS

ABX PENTRA µ-Alb Control:
Analyte	Albumin
Format	Purified human albumin added to a chemical buffer solution
Stability	Closed stability: 12 months at 2°C to 10°COpen stability:4 weeks at 2°C to 10°C

ABX PENTRA N Control:
Analytes	Already cleared (K052007, K060205, K060318, K060325, K060854, K062180)	Included in this submission
Alkaline phosphatase	√	√
Alanine aminotransferase	√	√
Amylase	√	√
Aspartate aminotransferase	√	√
Creatine kinase*
GGT	√	√
Lipase	√	√
Albumin		√
Direct Bilirubin	√	√
Total Bilirubin	√	√
Calcium	√	√
Chloride	√	√
Cholesterol	√	√
HDL	√	√
LDL	√	√
Creatinine	√	√
Glucose HK	√	√
Glucose PAP	√	√
Iron	√	√
Lactic acid	√	√
Magnesium	√	√
Phosphorus	√	√
Potassium	√	√
Sodium	√	√
Total Protein		√
Triglycerides	√	√
Urea / Blood Urea Nitrogen	√	√
Uric acid	√	√

HORIBA ABX, FRANCE

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

ABX PENTRA N Control:
Format	Lyophilized human serum with chemical additives and materialsof biological origin
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 2ºC to 8ºC2 weeks at -25°C to -15°C
	Total Bilirubin8 hours at 15°C to 25°C1 day at 2°C to 8°C2 weeks at -25°C to -15°C

Not cleared as of date of submission

HORIBA ABX, FRANCE

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

Analytes	Already cleared (K052007,K060205, K060318, K060325,K060854, K062180)	Included in this submission
Alkaline phosphatase	√	√
Alanine aminotransferase	√	√
Amylase	√	√
Aspartate aminotransferase	√	√
Creatine kinase*	√	√
GGT	√	√
Lipase	√	√
Albumin		√
Direct Bilirubin	√	√
Total Bilirubin	√	√
Calcium	√	√
Chloride	√	√
Cholesterol	√	√
HDL	√	√
LDL	√	√
Creatinine	√	√
Glucose HK	√	√
Glucose PAP	√	√
Iron	√	√
Lactic acid	√	√
Magnesium	√	√
Phosphorus	√	√
Potassium	√	√
Sodium	√	√
Total Protein		√
Triglycerides	√	√
Urea / Blood Urea Nitrogen	√	√
Uric acid	√	√
Format	Lyophilized human serum with chemical additives and materialof biological origin
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

HORIBA ABX, FRANCE :

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

**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

Not cleared as of date of submission

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.

HORIBA ABX, FRANCE

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

Image /page/10/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Horiba ABX c/o Pascal Macziola Pare Euromedecine Rue Du Caducee Montpellier, Herault, 34184 France

JUN - 5

Re: K060434

Trade/Device Name: ABX Pentra Albumin CP, ABX Pentra Total Protein CP, ABX Pentra Micro-albumin CP, ABX Pentra - Alb Control L/H, ABX Pentra u - Alb Cal, ABX Pentra N Control, ABX Pentra P Control, ABX Pentra Multical. Regulation Number: 21 CFR § 862.1035 Regulation Name: Albumin test system. Regulatory Class: Class II Product Code: CIX, CEK, JIQ, JIX, JIT, JJY Dated: April 13, 2007 Received: April 16, 2007

Dear Pascal Macziola:

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 (see 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 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 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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. 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): _ K060434

Device Name: Proteins on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

Proteins 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 Albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry.

Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

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)

Page 1 of 6

Carol C. Benson

Sign-On

Office of In Vitro Diagnostic Device -valuation and Safety

K060434

001 0 శ

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510(k) Number (if known): _ K060434

Device Name: _Proteins on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

ABX PENTRA Total Protein CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.

Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

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)

Page 2 of _6

Carol C. Benson

Sign-Off

Cice of In Vitro Diagnostic Device Juation and Safety

K060434

002 " 0 4

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K060434 510(k) Number (if known):

Device Name: Proteins on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

Measurements of albumin aids in the diagnosis of diabetic nephritis and other kidney and intestinal diseases.

The ABX PENTRA µ-Alb Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Micro-albumin CP method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA u-Alb Control L/H is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA Micro-albumin CP method.

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)

Page 3 of 6

Carl C. Benson

on Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K060434

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

510(k) Number (if known): K060434

Device Name: ABX PENTRA Multical

Indications For Use:

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

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)

Carol Bener
Sign-Off

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ି Tice of In Vitro Diagnostic Device Caluation and Safety

K060434

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510(k) Number (if known): _ K060434

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.

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)

Carol Benson

Sign-Off

୍ୱିତ of In Vitro Diagnostic Device The Juation and Safety

K060434

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510(k) Number (if known): K060434

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.

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

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

Page

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Team Sign-Off

ීce of In Vitro Diagnostic Device Ination and Safety

K060434

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Regulation Number and Section

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.