ABX PENTRA Cholesterol CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

ABX PENTRA HDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of High Density Lipoprotein Cholesterol (HDL-C) in human serum and plasma based on an enzymatic assay with accelerator selective detergent methodology.

ABX PENTRA LDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and plasma based on an enzymatic colorimetric assay.

ABX PENTRA Triglycerides CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of triglycerides in human serum and plasma based on an enzymatic colorimetric assay. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

The ABX PENTRA HDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HDL Direct CP method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA LDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA LDL Direct CP method on Horiba ABX clinical chemistry analyzers.

All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of their respective analytes : Cholesterol, HDL-C. LDL-C and Triglycerides using human serum and plasma. The controls, calibrators and additional reagents are intended for use in association with the above reagents.

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 Cholesterol CP is an in vitro diagnostic assay for the quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.

The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of High Density Lipoprotein Cholesterol (HDL-C) in human serum and plasma based on an enzymatic test, with accelerator selective detergent methodology. The assay is composed of a bi-reagent cassette, with 62 ml and 21 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and plasma based on an enzymatic colorimetric test. It is composed of a bi-reagent cassette, with 28 ml and 10 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA Triglycerides CP is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.

The ABX PENTRA HDL Cal is a lyophilized calibrator prepared from human serum. It is used for the calibration of the HDL-C assay. The assigned value is given in the enclosed annex. This calibrator is provided in two vials of 1 ml.

The ABX PENTRA LDL Cal is a lyophilized calibrator prepared from human serum. It is used for the calibration of the LDL-C assay. The assigned value is given in the enclosed annex. This calibrator is provided in two vials of 1 ml.

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 Clean-Chem CP and ABX PENTRA Clean-Chem 99 CP are ready-to-use chemical cleaning solutions for use on the ABX Pentra 400 system. They are respectively provided in mono-reagent 30 ml and 4 x 99 ml cassettes.

AI/ML Overview

This submission pertains to the Horiba ABX PENTRA line of reagents, calibrators, and controls for use with the ABX PENTRA 400 Clinical Chemistry Analyzer. The performance data discussed focuses on the quantitative determination of Cholesterol, HDL-C, LDL-C, and Triglycerides in human serum and plasma.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for each analyte are implicitly defined by the reported performance claims. The study demonstrates that the devices met these criteria.

ABX PENTRA Cholesterol CP:

Acceptance Criteria	Reported Device Performance
Sample Type	Serum & plasma
Detection Limit	4 mg/dl
Accuracy and Precision	CV Total < 3.01%
Measuring Range	2.55 mg/dl - 583.26 mg/dl
Upper Linearity Limit	580 mg/dl
Correlation (vs. Predicate)	Y = 0.95x + 1.90, r² = 0.9943 (n=135)
Calibration Stability	8 days
Reagent Stability	Closed: 24 months at 2-8°C; On-board: 48 days

ABX PENTRA HDL Direct CP:

Acceptance Criteria	Reported Device Performance
Sample Type	Serum & plasma
Detection Limit	1.16 mg/dl
Accuracy and Precision	CV Total < 3.52%
Measuring Range	5.4 mg/dl - 151.9 mg/dl
Upper Linearity Limit	154.8 mg/dl
Correlation (vs. Predicate)	Y = 0.91x + 1.98, r² = 0.9768 (n=121)
Calibration Stability	14 days
Reagent Stability	Closed: 22 months at 2-8°C; On-board: 31 days

ABX PENTRA LDL Direct CP:

Acceptance Criteria	Reported Device Performance
Sample Type	Serum & plasma
Detection Limit	1.55 mg/dl
Accuracy and Precision	CV Total < 6.39%
Measuring Range	1.35 mg/dl - 369.39 mg/dl
Upper Linearity Limit	387 mg/dl
Correlation (vs. Predicate)	Y = 0.96x - 0.21, r² = 0.9963 (n=122)
Calibration Stability	12 days
Reagent Stability	Closed: 18 months at 2-8°C; On-board: 97 days

ABX PENTRA Triglycerides CP:

Acceptance Criteria	Reported Device Performance
Sample Type	Serum & plasma
Detection Limit	7 mg/dl
Accuracy and Precision	CV Total < 2.83%
Measuring Range	3.1 mg/dl - 1434 mg/dl
Upper Linearity Limit	1470 mg/dl (5580 mg/dl with auto post-dilution)
Correlation (vs. Predicate)	Y = 0.99x + 0.20, r² = 0.9994 (n=135)
Calibration Stability	14 days
Reagent Stability	Closed: 16 months at 2-8°C; On-board: 48 days

2. Sample Size and Data Provenance

Cholesterol CP: Test set sample size: 135
HDL Direct CP: Test set sample size: 121
LDL Direct CP: Test set sample size: 122
Triglycerides CP: Test set sample size: 135

The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the manufacturer is Horiba ABX, France, it is likely the studies were conducted in France or a European context. The data appears to be derived from analytical performance studies, which are typically prospective in nature for device validation.

3. Number and Qualifications of Experts for Ground Truth

This information is not provided in the given document. The ground truth for these types of in vitro diagnostic devices usually refers to a reference method or a legally marketed predicate device against which the new device's performance is correlated, rather than expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the given document. Adjudication methods like 2+1 or 3+1 typically apply to studies involving human readers interpreting medical images or clinical data, which is not the nature of this in vitro diagnostic device study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and not provided in the given document. MRMC studies are used to evaluate human reader performance with and without AI assistance, which is not relevant for an in vitro diagnostic reagent and calibrator kit.

6. Standalone (Algorithm Only) Performance Study

The performance data presented, including correlation, accuracy, precision, detection limit, measuring range, and linearity, represents the standalone performance of the ABX PENTRA reagents and calibrators when used with the ABX PENTRA 400 Clinical Chemistry Analyzer. The "algorithm" in this context refers to the chemical assay methodology and the analyzer's processing capabilities. The correlation values (e.g., Y = 0.95x + 1.90 with r² = 0.9943 for Cholesterol CP) demonstrate the agreement of the new device's measurements with those obtained by a "predicate device" or reference method, indicating its standalone analytical effectiveness.

7. Type of Ground Truth Used

The ground truth used for the correlation studies was likely the results obtained from the predicate devices against which the new HORIBA ABX PENTRA assays were compared. For example, for ABX PENTRA Cholesterol CP, the predicate device was K941573. The correlation equations (e.g., Y = 0.95x + 1.90) describe the relationship between the results of the new device (Y) and the predicate device (X).

8. Sample Size for the Training Set

This information is not provided in the document. For in vitro diagnostic devices, "training set" is generally not applicable in the same way as for AI/machine learning models. The development and optimization of the chemical reagents and assay parameters would involve internal R&D, but specific "training set" sizes are not typically reported in 510(k) summaries for such devices.

9. How Ground Truth for the Training Set Was Established

This information is not provided and is largely not applicable in the context of this type of device. The ground truth for developing and optimizing chemical assays would involve established analytical chemistry principles, reference materials, validation experiments, and comparisons with existing gold-standard or well-characterized methods, rather than an explicitly defined "ground truth for a training set" as seen in AI/ML development.

Summary

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Premarket Notification [510(k)] Summary

AUG 2 4 2006

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

The assigned 510(k) number is : K060854_________________________________________________________________________________________________________________________

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

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

Date Prepared: 10 July 2006

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:

Trade/Proprietary Name:	ABX PENTRA Cholesterol CP
Common or Usual Name:	Cholesterol
Device Class	Class I
Classification Name:	8862.1175 : Cholesterol (Total) Test System
Product Code:	CHH ; Enzymatic Esterase-Oxidase, Cholesterol
Trade/Proprietary Name:	ABX PENTRA HDL Direct CP
Common or Usual Name:	HDL Cholesterol

Class I §862.1475 : Lipoprotein Test System LBS ; LDL/VLDL Precipitation, Cholesterol via Esterase-Oxidase, HDL

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

ABX PENTRA LDL Direct CP

LDL Cholesterol Class I $862.1475 : Lipoprotein Test System LBS ; LDL/VLDL Precipitation, Cholesterol via Esterase-Oxidase, HDL

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

ABX PENTRA Triglycerides CP

Triglycerides Class I §862.1705 : Triglycerides Test System SBT ; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

CALIBRATORS:

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

ABX PENTRA HDL Cal

HDL Calibrator Class II $862.1150 : Calibrator JIT ; Calibrator, Secondary

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

ABX PENTRA LDL Cal LDL Calibrator Class II $862.1150 : Calibrator JIT ; Calibrator, Secondary

ABX PENTRA Multical (K052007)

Multical Class II 8862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture

CONTROLS :

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:

CLEANING SOLUTIONS:

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)

ABX PENTRA P Control (K052007)

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

ABX PENTRA Clean-Chem CP (K052007)

Cleaning solution : Clean-Chem Class I : Exempt from Premarket Not available Not available

HORIBA ABX, FRANCE

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

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

ABX PENTRA Clean-Chem 99 CP (K052007)

Cleaning solution : Clean-Chem 99 Class I : Exempt from Premarket Not available Not available

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 Cholesterol CP	K941573
ABX PENTRA HDL Direct CP	K021316
ABX PENTRA LDL Direct CP	K971573
ABX PENTRA Triglycerides CP	K893973
ABX PENTRA HDL Cal	K021316
ABX PENTRA LDL Cal	K971573
ABX PENTRA Multical	K052007
ABX PENTRA N Control	K052007
ABX PENTRA P Control	K052007

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 HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of High Density Lipoprotein Cholesterol (HDL-C) in human squantaan plasma based on an enzymatic test, with accelerator selective detergent methodology. The assay is composed of a bi-reagent cassette, with 62 ml and 21 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and

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plasma based on an enzymatic colorimetric test. It is composed of a bi-reagent cassette, with 28 ml and 10 ml compartments. Reagents are chemical solutions with additives.

Intended Use :

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

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Discussion of Performance Data:

ABX PENTRA Cholesterol CP :
Sample type	Serum & plasma
Detection limit	4 mg/dl
Accuracy and Precision	CV Total < 3.01%
Measuring range	2.55 mg/dl - 583.26 mg/dl
Upper linearity limit	580 mg/dl
Correlation (n=135)	Y = 0.95 x + 1.90 with a correlation coefficient r² = 0.9943.
Calibration stability	8 days
Reagent stability	closed stability: 24 months at 2-8°Con-board stability (refrigerated area): 48 days

ABX PENTRA HDL Direct CP :
Sample type	Serum & plasma
Detection limit	1.16 mg/dl
Accuracy and Precision	CV Total < 3.52%
Measuring range	5.4 mg/dl - 151.9 mg/dl
Upper linearity limit	154.8 mg/dl
Correlation (n=121)	Y = 0.91 x + 1.98 with a correlation coefficient r2 = 0.9768.
Calibration stability	14 days
Reagent stability	closed stability: 22 months at 2-8°Con-board stability (refrigerated area): 31 days

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ABX PENTRA LDL Direct CP :
Sample type	Serum & plasma
Detection limit	1.55 mg/dl
Accuracy and Precision	CV Total < 6.39%
Measuring range	1.35 mg/dl - 369.39 mg/dl
Upper linearity limit	387 mg/dl
Correlation (n=122)	Y = 0.96 x - 0.21 with a correlation coefficient r2 = 0.9963.
Calibration stability	12 days
Reagent stability	closed stability: 18 months at 2-8°Con-board stability (refrigerated area): 97 days

ABX PENTRA Triglycerides CP :
Sample type	Serum & plasma
Detection limit	7 mg/dl
Accuracy and Precision	CV Total < 2.83%
Measuring range	3.1 mg/dl - 1434 mg/dl
Upper linearity limit	1470 mg/dl, with an automatique post-dilution : 5580 mg/dl
Correlation (n=135)	Y = 0.99 x + 0.20 with a correlation coefficient r² = 0.9994.
Calibration stability	14 days
Reagent stability	closed stability: 16 months at 2-8°Con-board stability (refrigerated area): 48 days

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CALIBRATORS

ABX PENTRA HDL Cal:
Analytes	High Density Lipoprotein Cholesterol (HDL-C)
Format	Lyophilized preparation of human serum
Stability	Closed stability: 24 months at 2°C to 8°COpen stability:14 days at 2°C to 8°C4 weeks at -70°C

ABX PENTRA LDL Cal:
Analytes	Low Density Lipoprotein Cholesterol (LDL-C)
Format	Lyophilized preparation of human serum
Stability	Closed stability: 24 months at 2°C to 8°COpen stability:2 weeks at 2°C to 8°C

THIS PART IS LEFT INTENTIONALLY BLANK

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ABX PENTRA Multical:
Analytes	Already cleared (K052007)	Included in this submission
Alkaline phosphatase*
Alanine aminotransferase*
Amylase*
Aspartate aminotransferase*
Creatine kinase*
GGT*
Lactate Dehydrogenase*
Lipase*
Albumin*
Direct Bilirubin*
Total Bilirubin*
Calcium*
Cholesterol		4
Creatinine*
Glucose HK	2
Glucose PAP	4	r
Iron*
Lactic acid*
Magnesium*
Phosphorus*
Total Protein*
Triglycerides
Urea / Blood Urea Nitrogen*		4
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
	**ExceptionsDirect Bilirubin3 hours at 15°C to 25°C8 hours at 2℃ to 8℃2 weeks at -25°C to -15°CTotal Bilirubin6 hours at 15°C to 25°C1 day at 2℃ to 8℃
	2 weeks at -25°C to -15°C
* Not cleared as of date of submission

HORIBA ABX, FRANCE

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CONTROLS

ABX PENTRA N Control:
Analytes	Already cleared (K052007)	Included in this submission
Alkaline phosphatase*
Alanine aminotransferase*
Amylase*
Aspartate aminotransferase*
Creatine kinase*
GGT*
Lactate Dehydrogenase*
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 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
	**Exceptions
ABX PENTRA N Control:
	Direct Bilirubin4 hours at 15°C to 25°C8 hours at 2°C to 8°C2 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

HORIBA ABX, FRANCE

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

Not cleared as of date of submission

THIS PART IS LEFT INTENTIONALLY BLANK

HORIBA ABX, FRANCE

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

ABX PENTRA P Control:
Analytes	Already cleared (K052007)	Included in this submission
Alkaline phosphatase*
Alanine aminotransferase*
Amylase*
Aspartate aminotransferase*
Creatine kinase*
GGT*
Lactate Dehydrogenase*
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 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°CExceptionsDirect Bilirubin4 hours at 15°C to 25°C8 hours at 2°C to 8°C2 weeks at -25°C to -15°CTotal 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, FRANCE

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Not cleared as of date of submission

CLEANING SOLUTIONS

ABX PENTRA Clean-Chem CP:
Format	Chemical liquid solution
Stability	Closed stability: 8 months at 2-8°COn-board stability (refrigerated area): 15 days

ABX PENTRA Clean-Chem 99 CP:
Format	Chemical liquid solution
Stability	Closed stability: 8 months at 2-8°COn-board stability (refrigerated area): 45 days

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/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

AUG 2 4 2006

K060854 Re:

Trade/Device Name: Lipoproteins and associated calibrators and controls on ABX PENTRA 400 Clinical Chemistry Analyzer Regulation Number: 21CFR§-862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, CHH, JJY, CDT, LBR, MRR Dated: July 10, 2006

Received: July 14, 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 (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) 276-0484. 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 Guticarez, 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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Indications for Use

510(k) Number (if known): K060854

Device Name: Lipoproteins and associated calibrators and controls on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Prescription Use X (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

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety Evaluation of in Vitro Dia
Evaluation and Safety

K060854

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Indications for Use

510(k) Number (if known): K060854

Device Name: Lipoproteins and associated calibrators and controls on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

The ABX PENTRA HDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HDL Direct CP method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA LDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA LDL Direct CP method 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)

Curl Benson

Page 2 of 2

ivision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K060854

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.