ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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

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

Device Description

All the reagent, controls and calibrator 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 Creatinine 120 CP is an in vitro diagnostic assay for the quantitative in vitro determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a bi-reagent cassette (R1= 27.5 mL ; R2= 8 mL). Reagents are chemical solutions with additives.

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

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 SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for the ABX PENTRA Creatinine 120 CP reagent and associated calibrators/controls, for use on the ABX PENTRA 400 clinical chemistry analyzer.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
ABX PENTRA Creatinine 120 CP (Reagent)
Detection limit (Serum/Plasma)	N/A (Comparison to predicate implies similar or better performance)	0.074 mg/dl
Detection limit (Urine)	N/A	1.40 mg/dl
Limit of Quantitation (Serum/Plasma)	N/A	0.22 mg/dl
Limit of Quantitation (Urine)	N/A	2.90 mg/dl
Accuracy and Precision (Serum/Plasma)	N/A (likely defined by an allowable CV% based on clinical standards or predicate)	CV. Total < 4.72%
Accuracy and Precision (Urine)	N/A	CV Total < 2.06%
Measuring range (Serum/Plasma)	N/A	0.22 mg/dl - 18.08 mg/dl
Measuring range (Urine)	N/A	2.90 mg/dl - 282.50 mg/dl
Upper linearity limit (Serum/Plasma)	N/A	18.08 mg/dl (54.24 mg/dl with automatic post-dilution)
Upper linearity limit (Urine)	N/A	282.5 mg/dl (847.50 mg/dl with automatic post-dilution)
Correlation (Serum/Plasma)	N/A (likely a high correlation coefficient with the predicate method)	Y = 0.99 x + 0.03 (mg/dl) with r2 = 0.9984
Correlation (Urine)	N/A	Y = 1.00 x - 0.60 (mg/dl) with r2 = 0.9984
Calibration stability (Serum/Plasma)	N/A (Standard stability duration for similar reagents)	3 days
Calibration stability (Urine)	N/A	3 days
Reagent stability (closed)	N/A	36 months at 2-8°C
Reagent stability (on-board)	N/A	19 days
ABX PENTRA Multical (Calibrator)
Stability (Closed)	N/A (Typical shelf-life for calibrators)	24 months at 2-8°C
Stability (Open, general)	N/A (Typical in-use stability for calibrators)	8 hours at 15-25°C; 2 days at 2-8°C; 2 weeks at -25 to -15°C
Stability (Open, Direct Bilirubin)	N/A	3 hours at 15-25°C; 8 hours at 2-8°C; 2 weeks at -25 to -15°C
Stability (Open, Total Bilirubin)	N/A	6 hours at 15-25°C; 1 day at 2-8°C
ABX PENTRA N Control (Control)
Stability (Closed)	N/A	30 months at 2-8°C
Stability (Open, general)	N/A	12 hours at 15-25°C; 5 days at 2-8°C; 1 month at -25 to -15°C
Stability (Open, Direct Bilirubin)	N/A	4 hours at 15-25°C; 8 hours at 2-8°C; 2 weeks at -25 to -15°C
Stability (Open, Total Bilirubin)	N/A	8 hours at 15-25°C; 1 day at 2-8°C; 2 weeks at -25 to -15°C
ABX PENTRA P Control (Control)
Stability (Closed)	N/A	30 months at 2-8°C
Stability (Open, general)	N/A	12 hours at 15-25°C; 5 days at 2-8°C; 1 month at -25 to -15°C
Stability (Open, Direct Bilirubin)	N/A	4 hours at 15-25°C; 8 hours at 2-8°C; 2 weeks at -25 to -15°C
Stability (Open, Total Bilirubin)	N/A	8 hours at 15-25°C; 1 day at 2-8°C; 2 weeks at -25 to -15°C
ABX PENTRA Urine Control L/H (Control)
Stability (Closed)	N/A	2 years at 2-8°C
Stability (Open)	N/A	30 days at 2-8°C

Note: The document explicitly states "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." However, the exact numerical acceptance criteria values themselves (e.g., maximum allowable CV, minimum r2) for each parameter are not explicitly defined in the provided text, but are implied by the reported performance falling within acceptable ranges for substantial equivalence to the predicate devices.

2. Sample sizes used for the test set and the data provenance

Creatinine 120 CP (Test Set):
- Serum/Plasma Correlation: n = 165
- Urine Correlation: n = 117
Data Provenance: Not explicitly stated, but the company is Horiba ABX SAS, FRANCE, suggesting the data may originate from France or related study sites. The study is for premarket notification, implying prospective testing for device performance.

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

This information is not provided in the text. For in vitro diagnostic devices like this, ground truth is typically established by comparing performance to an established, often predicate, method or reference method, rather than through expert consensus in the way a medical imaging AI might use radiologists.

4. Adjudication method for the test set

This information is not provided as it's not relevant for this type of in vitro diagnostic device performance study. Performance is assessed quantitatively against a reference method or specified analytical limits.

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 information is not applicable/not provided. This is an in-vitro diagnostic assay and associated controls/calibrators, not an AI-assisted diagnostic tool that involves human readers interpreting results.

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

This is a standalone diagnostic assay (reagent, calibrator, control) for use on an automated clinical chemistry analyzer (ABX PENTRA 400). The performance data presented (detection limits, accuracy, precision, measuring range, correlation, stability) reflect the standalone analytical performance of the device on the analyzer. There is no "human-in-the-loop" component for the measurement process itself beyond loading samples and reagents.

7. The type of ground truth used

For the ABX PENTRA Creatinine 120 CP reagent, the ground truth for correlation studies was established by comparing its measurements (Y) against those of the predicate device/method (X), as indicated by the correlation equations (e.g., "Y = 0.99 x + 0.03"). This implies a comparative method ground truth (i.e., comparison against a legally marketed, established method).
For the calibrators and controls, the "assigned values" of their components serve as their reference values or ground truth, established through rigorous manufacturing and value assignment processes.

8. The sample size for the training set

This information is not provided. This type of in vitro diagnostic device is chemically based and does not typically involve a "training set" in the machine learning sense. The development likely involves extensive R&D and analytical validation, but not a distinct "training set" of patient data for a learning algorithm.

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

This information is not applicable as there is no "training set" in the context of this device's development as described.

Summary

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APR 3 0 2012

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 : K110530

Company: Horiba ABX SAS Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 18 43 Fax: + (33) 4 67 14 15 17

Contact Person: Caroline Ferrer (caroline.ferrer@horiba.com)

Date Prepared: 12th April, 2012

Device Names:

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

REAGENTS :

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

CALIBRATORS:

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

CONTROLS :

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

ABX PENTRA Creatinine 120 CP

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

ABX PENTRA Multical (K052007)

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

ABX PENTRA N Control (K052007)

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

HORIBA ABX SAS, FRANCE

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Trade/Proprietary Name:	ABX PENTRA P Control (K052007)
Common or Usual Name:	P Control
Device Class	Class I
Classification Name:	§862.1660 : Quality control material (assayed)
Product Code:	JJY ; Multi-Analyte Controls, All Kinds (assayed)
Trade/Proprietary Name:	ABX PENTRA Urine Control L/H (K070249)
Common or Usual Name:	Urine control
Device Class	Class I
Classification Name:	§862.1660 : Quality control material (assayed)
Product Code:	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 Creatinine 120 CP	K934361
ABX PENTRA Multical	K052007
ABX PENTRA N Control	K052007
ABX PENTRA P Control	K052007
ABX PENTRA Urine Control L/H	K070249

Description:

All the reagent, controls and calibrator included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

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Intended Use:

All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of Creatinine using human serum, plasma and/or urine.

The controls and calibrator are intended for use in association with the above reagent.

HORIBA ABX SAS, FRANCE

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Discussion of Performance Data:

ABX PENTRA Creatinine 120 CP :
Sample type	Serum, Plasma and Urine
Detection limit	Serum/Plasma : 0.074 mg/dlUrine : 1.40 mg/dl
Limit of Quantitation	Serum/Plasma : 0.22 mg/dlUrine : 2.90 mg/dl
Accuracy and Precision	Serum/Plasma CV. Total < 4.72%Urine CV Total < 2.06%
Measuring range	Serum/Plasma : 0.22 mg/dl - 18.08 mg/dlUrine : 2.90 mg/dl - 282.50 mg/dl
Upper linearity limit	Serum/Plasma : 18.08 mg/dl, and with automatic post-dilution :54.24 mg/dlUrine : 282.5 mg/dl, and with automatic post-dilution : 847.50mg/dl
Correlation	Serum/Plasma (n=165): Y = 0.99 x + 0.03 (mg/dl) with r2 =0.9984Urine (n=117) : Y = 1.00 x - 0.60 (mg/dl) with r2 = 0.9984
Calibration stability	Serum/Plasma : 3 daysUrine : 3 days
Reagent stability	closed stability: 36 months at 2-8°Con-board stability : 19 days

CALIBRATOR

and the comments

ABX PENTRA Multical:
Analytes	Already cleared(K052007, K060205, K060318,K060325, K060854, K062180,K062737, K060434, K072115,K110137)	Included in this submission
Alkaline phosphatase	√	√
Alanine aminotransferase	√	√
Amylase	√	√
Aspartate aminotransferase	√	√
Creatine kinase	√	√
GGT	√	√
LDH	√	√
Lipase	√	√

HORIBA ABX SAS, FRANCE

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ABX PENTRA Multical:
Albumin	√	√
Direct Bilirubin	√	√
Total Bilirubin	√	√
Calcium	√	√
Cholesterol	√	√
Creatinine 120	√	√
New Creatinine 120		√
Enzymatic Creatinine CP	√	√
Glucose HK	√	√
Glucose PAP	√	√
Iron	√	√
Lactic acid	√	√
Magnesium	√	√
Phosphorus	√	√
Total Protein	√	√
Total Protein 100	√	√
Triglycerides	√	√
Urea / Blood Urea Nitrogen	√	√
Uric acid	√	√
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°C

CONTROLS

and the comments of the comments of the comments of

ABX PENTRA N Control:
Analytes	Already cleared(K052007, K060205, K060318,K060325, K060854, K062180,K062737, K060434, K072115,K110137)	Included in this submission

HORIBA ABX SAS, FRANCE

ં ર

Carolina Career States

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ABX PENTRA N Control:
Alkaline phosphatase	√	√
Alanine aminotransferase	√	√
Amylase	√	√
Aspartate aminotransferase	√	√
Creatine kinase	√	√
GGT	√	√
LDH	√	√
Lipase	√	√
Albumin	√	√
Direct Bilirubin	√	√
Total Bilirubin	√	√
Calcium	√	√
Chloride	√	√
Cholesterol	√	√
HDL	√	√
LDL	√	√
Creatinine 120	√	√
New Creatinine 120		√
Enzymatic Creatinine CP	√	√
Glucose HK	√	√
Glucose PAP	√	√
Iron	√	√
Lactic acid	√	√
Magnesium	√	√
Phosphorus	√	√
Potassium	√	√
Sodium	√	√
Total Protein	√	√
Total Protein 100	√	√
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
	Direct Bilirubin
	4 hours at 15°C to 25°C
ABX PENTRA N Control:	8 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

. . . . .

HORIBA ABX SAS, FRANCE

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. . . . . .

100 - 100 - 100

. . . . . . . .

. .

. . .

and the comments of the comments of

HORIBA ABX SAS, FRANCE ---------

and the comments of the comments of

: 上

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ABX PENTRA P Control:Analytes	Already cleared(K052007, K060205, K060318,K060325, K060854, K062180,K062737, K060434, K072115,K110137)	Included in this submission
Alkaline phosphatase	√	√
Alanine aminotransferase	√	√
Amylase	√	√
Aspartate aminotransferase	√	√
Creatine kinase	√	√
GGT	√	√
LDH	√	√
Lipase	√	√
Albumin	√	√
Direct Bilirubin	√	√
Total Bilirubin	√	√
Calcium	√	√
Chloride	√	√
Cholesterol	√	√
HDL	√	√
LDL	√	√
Creatinine 120	√	√
New Creatinine 120		√
Enzymatic Creatinine CP	√	√
Glucose HK	√	√
Glucose PAP	√	√
Iron	√	√
Lactic acid	√	√
Magnesium	√	√
Phosphorus	√	√
Potassium	√	√
Sodium	√	√
Total Protein	√	√
Total Protein 100	√	√
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°C
ABX PENTRA P Control:
	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

1.00

HORIBA ABX SAS, FRANCE

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------8

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ABX PENTRA Urine Control L/H:
Analytes	Already cleared (K07249, K072115, K110137)	Included in this submission
Amylase	√	√
Calcium	√	√
Creatinine 120	√	√
New Creatinine 120		√
Enzymatic Creatinine CP	√	√
Phosphorus	√	√
Glucose	√	√
Urea / Blood Urea Nitrogen	√	√
Uric acid	√	√
Urinary proteins		√
Format	Liquid solution prepared from human urine with chemical additives and materials of biological origin
Stability	Closed stability: 2 years at 2-8°COpen stability: 30 days at 2-8°C

Conclusions for Performance Testing :

・・

The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized representation of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. The emblem itself is a stylized design, possibly representing human figures or abstract shapes.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Horiba ABX SAS c/o Ms. Caroline Ferrer Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE

APR 3 9 2012

Re: K110530

Trade Name: ABX PENTRA Creatinine 120 CP on ABX PENTRA 400 Clinical . Chemistry Analyzer; ABX PENTRA Multical, ABX PENTRA N Control, ABX PENTRA P Control, ABX PENTRA Urine Control L/H

Regulation Number: 21 CFR §862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Codes: CGX, JIX, JJY Dated: April 23, 2012 Received: April 25, 2012

Dear Ms. Ferrer:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...

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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

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

Enclosure

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K110530 510(k) Number (if known):

Device Name: ABX Pentra Creatinine 120 CP on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications 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 (OVD)

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

510(k) K110530

Page 1 of 5

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110530

.510(k) Number (if known):

Device Name: ABX PENTRA Multical

Indication For Use:

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

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 (OVD)

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

510(k) K110530

Page 2 of 5

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110530

510(k) Number (if known):

Device Name: ABX PENTRA N Control

Indication For Use:

The ABX PENTRA N Control 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 (OVD)

Division Sign Off

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

510(k) K110530

Page 3 of 5

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510(k) Number (if known):

KII0530

Device Name: ABX PENTRA P Control

Indication For Use:

The ABX PENTRA P Control 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)

Signature

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

510(k) K110530

Page 4 of 5

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KU0530 510(k) Number (if known):

Device Name: ABX PENTRA Urine Control L/H

Indication For Use:

The 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 (OVD)

Signature

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

510(k) K110530

Page 5 of 5

Regulation Number and Section

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.