ABX PENTRA Glucose HK CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of uric acid in human serum, plasma and urine 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.

ABX PENTRA Urine Control L/H 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 bench top clinical chemistry analyzer.

The ABX PENTRA Glucose HK CP is an in vitro diagnostic assay for the quantitative determination of glucose in human serum, plasma and urine based on an enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase. It is composed of a bi-reagent cassette, with 56 ml and 14 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA Uric Acid CP is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). It is composed of a bi-reagent cassette, with 60 ml and 15 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA Glucose HK CP and ABX PENTRA Uric Acid CP, focusing on the added urine sample performance. The ABX PENTRA Urine Control L/H is simply a control for these assays and its performance is described in terms of stability, not analytical performance.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (ABX PENTRA Glucose HK CP - Urine)	Reported Device Performance (ABX PENTRA Uric Acid CP - Urine)
Limit of Blank	Not explicitly stated	1.95 mg/dl	2.33 mg/dl
Limit of Detection	Not explicitly stated	2.9 mg/dl	3.49 mg/dl
Limit of Quantitation	Not explicitly stated	3.3 mg/dl	5.20 mg/dl
Accuracy and Precision	CV Total < 5% (Implied)	CV Total < 4.82%	CV Total < 4.36%
Linearity	Adequate range for clinical use (Implied)	3.9 mg/dl - 900 mg/dl	5.20 mg/dl - 252 mg/dl
Measuring range	Adequate for clinical use (Implied)	3.9 mg/dl - 900 mg/dl (up to 2700 mg/dl with auto-dilution)	5.20 mg/dl - 252.00 mg/dl (up to 756.00 mg/dl with auto-dilution)
Correlation (R²) vs. Reference	> 0.99 (Implied, from context of "correlation coefficient")	r² = 0.997 (Y = 0.96 x + 0.84 mg/dl)	r² = 0.9949 (Y = 1.01 x + 0.99 mg/dl)
Calibration stability	Not explicitly stated	21 days	15 days
Reagent stability (closed)	Not explicitly stated	36 months at 2-8°C	36 months at 2-8°C
Reagent stability (on-board)	Not explicitly stated	55 days (refrigerated area)	41 days (refrigerated area)

Note: The document states that the performance testing data demonstrated that the devices "met all acceptance criteria." However, explicit numerical acceptance criteria are not provided for all metrics. The reported performance values themselves serve as the demonstration of meeting internal acceptance criteria. For correlation, an R² value of >0.99 is generally considered excellent in such studies, hence the implied criterion. For CV Total, often <5% is an industry standard for analytical precision.

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

Glucose HK CP:
- Sample Size: n=208 (for correlation study on urine samples).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This information is typically proprietary. The submission is from France, which might imply data from that region, but it's not confirmed. It's likely retrospective data collection from clinical samples.
Uric Acid CP:
- Sample Size: n=226 (for correlation study on urine samples).
- Data Provenance: Not explicitly stated (same as above).

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

This type of information is not applicable to this submission. The "devices" in question are in vitro diagnostic assays for quantitative determination of analytes (glucose and uric acid). The "ground truth" for these tests is established by a reference method or a comparative device, not by expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

This is not applicable as the ground truth is established by a quantitative measurement method, not through expert scoring or review requiring adjudication.

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. This submission concerns quantitative in-vitro diagnostic assays, not AI-assisted image interpretation or clinical decision support systems involving human readers.

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

This is not applicable. These are reagent-based assays run on an automated analyzer (ABX PENTRA 400), not standalone algorithms. Their performance is inherently "standalone" in the sense that the analyzer provides a direct quantitative result.

7. The Type of Ground Truth Used

The ground truth used for these quantitative assays is a comparative method or reference method. The correlation studies (e.g., Y = 0.96 x + 0.84 mg/dl) indicate a comparison to a "reference" method, where 'x' typically represents the result from the reference method and 'Y' represents the result from the new device. The document does not specify what the exact reference method was, but for glucose and uric acid, these are well-established laboratory techniques.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in the context of traditional quantitative IVD assays like these. These methods are developed based on chemical principles and validation studies, not "trained" on data sets in the way AI algorithms are.

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

This is not applicable for the reasons outlined in point 8. The assays are based on established enzymatic reactions and photometric measurement, not on a "training set" with ground truth established through a separate process.

Summary

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Image /page/0/Picture/1 description: The image contains a handwritten number, which appears to be "1081276". The numbers are written in a connected manner, with some variations in stroke thickness. The handwriting is somewhat stylized, but the numbers are still legible.

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 : K081276

Company:	Horiba ABX SASParc EuromédecineRue du Caducée – BP 729034184 Montpellier cedex 4FRANCE
Telephone:	+ (33) 4 67 14 73 92
Fax:	+ (33) 4 67 14 15 17

Contact Persons: Olivier Ducamp (oducamp@fr.abx.fr) Caroline Ferrer (cferrer@fr.abx.fr)

Date Prepared: 03rd September 2008

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 Glucose HK CP
Common or Usual Name:	Glucose HK
Device Class	Class II
Classification Name:	§862.1345 : Glucose Test System
Product Code:	CFR; Hexokinase, Glucose
Trade/Proprietary Name:	ABX PENTRA Uric Acid CP
Common or Usual Name:	Uric Acid
Device Class	Class I
Classification Name:	§862.1775 : Uric acid Test System
Product Code:	KNK ; acid, uric, uricase (colorimetric)

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

ABX PENTRA Urine Control L/H

Urine control Class I §862. 1660 : Quality control material (assayed) JJY ; Multi-Analytc 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 Glucose HK CP	K944406
ABX PENTRA Uric Acid CP	K971485
ABX PENTRA Urine Control L/H	K070146

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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 bench top clinical chemistry analyzer.

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 (Glucose, Uric Acid) using human serum, plasma and/or urine.

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

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Discussion of Performance Data:

ABX Pentra Glucose HK CP (K052007) and ABX Pentra Uric Acid CP (K060205) have already been cleared by the FDA for use on serum and plasma samples. No modification has been made to these devices. The performances on serum and plasma samples have not been modified.

Therefore, for these 2 devices, only added performances, on urine samples, are discussed below.

ABX PENTRA Glucose HK CP :
Sample type	Urine
Limit of Blank	1.95 mg/dl
Limit of Detection	2.9 mg/dl
Limit of Quantitation	3.3 mg/dl
Accuracy and Precision	CV Total < 4.82%
Linearity	3.9 mg/dl - 900 mg/dl
Measuring range	3.9 mg/dl - 900 mg/dl, , and with automatic post-dilution : up to2700 mg/dl
Correlation (n=208):	Y = 0.96 x + 0.84 mg/dl with a correlation coefficient r² = 0.997
Calibration stability	21 days
Reagent stability	closed stability: 36 months at 2-8°Con-board stability (refrigerated area): 55 days

ABX PENTRA Uric Acid CP :
Sample type	Urine
Limit of Blank	2.33 mg/dl
Limit of Detection	3.49 mg/dl
Limit of Quantitation	5.20 mg/dl
Accuracy and Precision	CV Total < 4.36%
Linearity	5.20 mg/dl - 252 mg/dl
Measuring range	5.20 mg/dl - 252.00 mg/dl, , and with automatic post-dilution :up to 756.00 mg/dl
Correlation (n=226):	Y = 1.01 x + 0.99 mg/dl with a correlation coefficient r2 = 0.9949
Calibration stability	15 days

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ABX PENTRA Uric Acid CP :
Reagent stability	closed stability: 36 months at 2-8°Con-board stability (refrigerated area): 41 days

CONTROLS

ABX PENTRA Urine Control L/H:
Analytes	Already cleared	Included in this submission
Amylase	√ (K070249)
Calcium	√ (K070249)
Creatinine	√ (K070249)
Phosphorus	√ (K070249)
Glucosc		√
Urea / Blood Urea Nitrogen	√ (K070146)
Uric acid		√
Urinary proteins	√ (510k exempt)
Format	Liquid solution prepared from human urine with chemicaladditives and materials of biological origin
Stability	Closed stability: 2 years at 2-8°COpen stability: 30 days at 2-8°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.

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Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle-like design with flowing lines, symbolizing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. The seal is presented in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 2 2008

HORIBA ABX Diagnostics c/o Mr. Olivier Ducamp, Regulatory Affairs Manager Parc Euromedecine, Rue du Caducee -- BP 7290 34184 Montpellier cedex 4 France

Re: K081276

Trade/Device Name: ABX PENTRA Glucose HK CP, ABX PENTRA Uric Acid CP, ABX PENTRA Urine Control L/H

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code(s): CFR, KNK, JJY Dated: August 13, 2008 Received: August 15, 2008

Dear Mr. Ducamp:

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 commercc 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.

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

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Indication for Use

608/276 510(k) Number (if known):

Device Name: ABX PENTRA Glucose HK CP

Indication For Use:

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081276

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Indication for Use

108 276 510(k) Number (if known):

Device Name: ABX PENTRA Uric Acid CP

Indication For Use:

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081276

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Indication for Use

510(k) Number (if known):

Device Name: ABX PENTRA Urine Control L/H

Indication For Use:

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

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of th Vitro Diagnostic Device Evaluation and Safety

510(k) K081276

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.