Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.

ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test.

Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy.

The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods.

ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoqlobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay.

Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease.

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

The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision.

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 CK NAC CP is an in vitro diagnostic assay for the quantitative determination of total creatine kinase in human serum and plasma based on an optimized UV test. The assay is composed of a bi-reagent cassette, with 26 ml and 6.5 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA Myoglobin CP is an in vitro diagnostic assay for the quantitative determination of myoglobin in human serum and plasma based on a latex-enhanced immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 15 ml and 9.5 ml compartments. Reagents are chemical solutions with chemical additives and substances of animal origin.

The ABX PENTRA Myoglobin Cal is a liquid calibrator prepared from a dilution of purified myoglobin positive human sera. It is used for the calibration of the myoglobin assay. The assigned values are given on the vials. This calibrator is provided in five vials of 1 ml.

The ABX PENTRA CK Control is a lyophilized assayed control prepared from a bovine serum albumin with chemical additives and material of biological origin. It has to be used for the quality control of the creatine kinase assay. The assigned values are given in the enclosed annex. This calibrator is provided in 4 vials of 3 ml.

The ABX PENTRA Immuno II Control L/H is a lyophilized assayed control prepared from a stabilized pool of human sera. It has 2 levels (Low and High) to be used for the quality control of the myoglobin assay. The assigned values are given in the enclosed annex. Each level of this control is provided in one vial of 3 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.

AI/ML Overview

This submission describes various reagents, controls, and calibrators for in vitro diagnostic use with the Horiba ABX Pentra 400 clinical chemistry analyzer. The performance data focuses on establishing substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily performance characteristics of the various reagents, controls, and calibrators.

ABX PENTRA CK NAC CP (Reagent for Total Creatine Kinase)

Acceptance Criteria	Reported Device Performance
Sample type	Serum & plasma
Detection limit	8 U/l
Accuracy and Precision	CV Total < 4.65%
Measuring range	8 U/l - 1500 U/l
Upper linearity limit	1500 U/l, and with automatic post-dilution: 4500 U/l
Correlation (n=350)	Y = 1.05 x - 1.75 with a correlation coefficient r² = 0.9930
Calibration stability	8 days
Reagent stability (closed)	18 months at 2-8°C
Reagent stability (on-board)	64 days (refrigerated area)

ABX PENTRA Myoglobin CP (Reagent for Myoglobin)

Acceptance Criteria	Reported Device Performance
Sample type	Serum & plasma
Detection limit	6.7 µg/l
Accuracy and Precision	CV Total < 5.24%
Measuring range	20.7 µg/l – 500 µg/l
Upper linearity limit	500 µg/l
Correlation (n=180)	Y = 0.94 x + 19.44 with a correlation coefficient r² = 0.9756
Calibration stability	21 days
Reagent stability (closed)	12 months at 2-8°C
Reagent stability (on-board)	35 days (refrigerated area)

ABX PENTRA Myoglobin Cal (Calibrator)

Acceptance Criteria	Reported Device Performance
Analytes	Myoglobin
Format	Liquid preparation of diluted purified myoglobin positive human sera: 5 levels
Stability (closed)	12 months at 2°C to 10°C
Stability (open)	7 weeks at 2°C to 10°C

ABX PENTRA Multical (Calibrator)

Acceptance Criteria (General)	Reported Device Performance
Analytes	Various, including Creatine kinase (included in this submission)
Format	Lyophilized human serum with chemical additives and materials of biological origin
Stability (closed)	24 months at 2-8°C
Stability (open)	General components: 8 hours at 15-25°C, 2 days at 2-8°C, 2 weeks at -25- -15°C Direct Bilirubin: 3 hours at 15-25°C, 8 hours at 2-8°C, 2 weeks at -25- -15°C Total Bilirubin: 6 hours at 15-25°C, 1 day at 2-8°C, 2 weeks at -25- -15°C

ABX PENTRA CK Control (Control)

Acceptance Criteria	Reported Device Performance
Analytes	Total Creatine Kinase
Format	Lyophilized preparation of bovine serum albumin with chemical additives and material of animal origin
Stability (closed)	18 months at 2°C to 8°C
Stability (open)	24 hours at 15°C to 25°C, 3 days at 2°C to 8°C

ABX PENTRA Immuno II Control L/H (Control)

Acceptance Criteria	Reported Device Performance
Analytes	Myoglobin
Format	Lyophilized preparation of bovine serum albumin with chemical additives and material of animal origin
Stability (closed)	18 months at 2°C to 10°C
Stability (open)	2 weeks at 2°C to 10°C, 3 months at -20°C

ABX PENTRA N Control and ABX PENTRA P Control (Controls)

Acceptance Criteria (General)	Reported Device Performance
Analytes	Various, including Creatine kinase (N Control, P Control)
Format	Lyophilized human serum with chemical additives and materials of biological origin
Stability (closed)	30 months at 2-8°C
Stability (open)	General components: 12 hours at 15-25°C, 5 days at 2-8°C, 1 month at -25- -15°C Direct Bilirubin: 4 hours at 15-25°C, 8 hours at 2-8°C, 2 weeks at -25- -15°C Total Bilirubin: 8 hours at 15-25°C, 1 day at 2-8°C, 2 weeks at -25- -15°C

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

ABX PENTRA CK NAC CP: Correlation study used n=350 samples.
ABX PENTRA Myoglobin CP: Correlation study used n=180 samples.
Data Provenance: Not explicitly stated, but the submission is from Horiba ABX, France. Given the nature of in vitro diagnostic device submissions for a global market, it is common for such studies to be conducted internally or at contract research organizations, potentially in the country of origin (France) or other locations. The document does not specify if the data is retrospective or prospective, but performance data for new IVD products is typically generated prospectively, though some method comparison might involve retrospective samples.

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

Not applicable. As an in vitro diagnostic device for quantitative determination of analytes, "ground truth" is typically established by reference methods or predicate devices, not by expert interpretation of images or clinical cases. The "experts" in this context would be the laboratory personnel performing the reference method assays or clinical chemists validating the results. Their qualifications are not detailed in this submission.

4. Adjudication Method for the Test Set

Not applicable. This is for an in vitro diagnostic assay, not a medical imaging or diagnostic interpretation device requiring adjudication of expert opinions. Performance is assessed through quantitative measurements, precision, accuracy, linearity, and correlation with predicate devices.

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-assisted diagnostic device. It's a collection of reagents, controls, and calibrators for a chemistry analyzer.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done

Not applicable for an IVD reagent/calibrator/control submission. The device performs a quantitative measurement on an automated analyzer. Its performance is inherently "standalone" in the sense that the analyzer and reagents perform the test without human interpretive input for the result itself. Human involvement is in sample handling, loading, running, and interpreting the numerical result in a clinical context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance studies (accuracy, correlation), the "ground truth" is established by comparison to results obtained from predicate devices (as detailed in the substantial equivalence table) or established reference methods. For example, the correlation studies show the device's results (Y) compared to a reference method or predicate device's results (x). Precision and linearity are evaluated against expected analytical performance criteria.

8. The Sample Size for the Training Set

Not applicable. These are chemical reagents, controls, and calibrators for an in vitro diagnostic assay, not an AI or machine learning algorithm that requires a "training set."

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

Not applicable, as there is no "training set" in the context of this type of device.

Summary

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

JUN 1 2 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 : K062737

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

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

Date Prepared: 24th 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 :

Product Code:

Trade/Proprietary Name:	ABX PENTRA CK NAC CP
Common or Usual Name:	Total Creatine kinase
Device Class	Class II
Classification Name:	§862.1215 : Creatine Phosphokinase/Creatine kinase or isoenzymesTest System
Product Code:	CGS ; Nad reduction/Nadh oxidation, Cpk or isoenzymes
Trade/Proprietary Name:	ABX PENTRA Myoglobin CP
Common or Usual Name:	Myoglobin
Device Class	Class II
Classification Name:	§866.5680 : Myoglobin immunological Test System

DDR ; Myoglobin, antigen, antiserum, control

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

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

ABX PENTRA Myoglobin Cal

Myoglobin Calibrator Class II §862.1150 : Calibrator JIT ; Calibrator, Secondary

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

ABX PENTRA Multical (K060854)

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

CONTROLS :

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

ABX PENTRA CK Control

CK 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 Immuno II Control L/H

Control Low/High Class I $862.1660 : Ouality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)

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

Trade/Proprietary Name:

Common or Usual Name:

Classification Name:

Device Class

Product Code:

ABX PENTRA N Control (K060854)

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

ABX PENTRA P Control (K060854)

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

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

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 CK NAC CP	K834502
ABX PENTRA Myoglobin CP	K021229
ABX PENTRA Myoglobin Cal	K021229
ABX PENTRA Multical	K060854
ABX PENTRA CK Control	K954074
ABX PENTRA Immuno II ControlL/H	K961828
ABX PENTRA N Control	K060854
ABX PENTRA P Control	K060854

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.

{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 : Total Creatine Kinase and Myoglobin using human serum and plasma.

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

HORIBA ABX, FRANCE

Section 5-4

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

Discussion of Performance Data:

ABX PENTRA CK NAC CP :
Sample type	Serum & plasma
Detection limit	8 U/l
Accuracy and Precision	CV Total < 4.65%
Measuring range	8 U/l - 1500 U/l
Upper linearity limit	1500 U/l, and with automatic post-dilution : 4500 U/l
Correlation (n=350)	$Y = 1.05 x - 1.75$ with a correlation coefficient $r^2 = 0.9930$ .
Calibration stability	8 days
Reagent stability	closed stability: 18 months at 2-8°Con-board stability (refrigerated area): 64 days

ABX PENTRA Myoglobin CP :
Sample type	Serum & plasma
Detection limit	6.7 $\mu$ g/l
Accuracy and Precision	CV Total < 5.24%
Measuring range	20.7 $\mu$ g/l – 500 $\mu$ g/l
Upper linearity limit	500 $\mu$ g/l
Correlation (n=180)	Y = 0.94 x + 19.44 with a correlation coefficient r2 = 0.9756.
Calibration stability	21 days
Reagent stability	closed stability: 12 months at 2-8°Con-board stability (refrigerated area): 35 days

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

CALIBRATORS

ABX PENTRA Myoglobin Cal:
Analytes	Myoglobin
Format	Liquid preparation of diluted purified myoglobin positive humansera : 5 levels
Stability	Closed stability: 12 months at 2°C to 10°COpen stability:7 weeks at 2°C to 10°C

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

HORIBA ABX, FRANCE

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

Format	Lyophilized human serum with chemical additives and materials of 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°CExceptionsDirect 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

Not cleared as of date of submission

CONTROLS

ABX PENTRA CK Control:
Analytes	Total Creatine Kinase
Format	Lyophilized preparation of bovine serum albumin with chemicaladditives and material of animal origin
Stability	Closed stability: 18 months at 2°C to 8°COpen stability:24 hours at 15°C to 25°C3 days at 2°C to 8°C

ABX PENTRA Immuno II Control L/H:
Analytes	Myoglobin
Format	Lyophilized preparation of bovine serum albumin with chemicaladditives and material of animal origin
Stability	Closed stability: 18 months at 2°C to 10°COpen stability:2 weeks at 2°C to 10°C3 months at -20°C

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

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

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

Format	Lyophilized human serum with chemical additives and materialsof 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

Not cleared as of date of submission

11:00 PM IST 11:00 PM

HORIBA ABX, FRANCE

Section 5-9

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

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

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

Format	Lyophilized human serum with chemical additives and materials of 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 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

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.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Horiba ABX c/o Pascal Macziola Regulatory Affairs Manager Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 France

JUN 1 2 2007

Re: K062737

Trade/Device Name: ABX Pentra CK NAC CP, ABX Pentra Myoglobin CP, ABX Pentra CK Control, ABX Pentra Immuno II Control L/H, ABX Pentra Myoglobin Cal, ABX Pentra N Control, ABX Pentra P Control, ABX Pentra Multical Regulation Number: 21 CFR & 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system. Regulatory Class: Class II Product Code: CGS, DDR, JIY, JIX, JIT Dated: April 25, 2007 Received: April 30, 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).

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

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 10(x) marketed predicate device results in a classification for your device and thus, berroits 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 tollefree number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

Yean 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

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

510(k) Number (if known):

Device Name: Cardíac Markers on ABX PENTRA 400 Clinical Chemistry Analyzer .

Indications For Use:

Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.

Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy.

The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods.

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 2 6

Carol Benson
Sign-Off

ాం of In Vitro Diagnostic Device uation and Safety

K062737

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

510(k) Number (if known):

Device Name: Cardiac Markers on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease.

The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin 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)

Page 2 of _q lo

Carol Benson
Sign-Off

ാ of In Vitro Diagnostic Device tion and Safety

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

510(k) Number (if known):

Device Name: ABX PENTRA Immuno II Control L/H

Indications For Use:

The ABX PENTRA Immuno II Control L/H 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)

(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

Carol C. Benson
Sign-Off

ice of In Vitro Diagnostic Device * aluation and Safety

K06 2737

{16}------------------------------------------------

510(k) Number (if known):

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 Benson
Sign-Off

ා of In Vitro Diagnostic Device ation and Safety

Page 4 of 6

{17}------------------------------------------------

510(k) Number (if known):

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 C. Benson

Sign-Off

Sign-Up

୍ତ of In Vitro Diagnostic Device stion and Safety

Page 5 of 6

K062737

{18}------------------------------------------------

510(k) Number (if known):

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 × (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

Page bof b

be of In Vitro Diagnostic Device Tuation and Safety

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.