ABX PENTRA Enzymatic Creatinine 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 an enzymatic method using a multi-step approach ending with a photometric end-point reaction. 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 Enzymatic Creatinine CP is an in vitro diagnostic assay for the quantitative in vitro determination of creatinine in human serum, plasma and urine based on an enzymatic method using a multi-step approach ending with a photometric end-point reaction. It is composed of a bi-reagent cassette (R1= 22 mL ; R2= 8 mL). Reagent is a chemical solution 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 annexe, 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 performance data for the ABX PENTRA Enzymatic Creatinine CP reagent, along with associated calibrators and controls, for use on the ABX PENTRA 400 clinical chemistry analyzer. The study aims to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance data for the ABX PENTRA Enzymatic Creatinine CP reagent, which implicitly serve as acceptance criteria for its clearance.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Detection Limit	Not explicitly stated as acceptance criteria, but reported values are key performance indicators.	Serum/Plasma: 0.026 mg/dlUrine: 0.66 mg/dl
Limit of Quantitation	Not explicitly stated as acceptance criteria, but reported values are key performance indicators.	Serum/Plasma: 0.11 mg/dlUrine: 1.71 mg/dl
Accuracy and Precision	Total CV for Serum/Plasma < 4.12%Total CV for Urine < 4.84%	Serum/Plasma CV Total < 4.12%Urine CV Total < 4.84%
Measuring Range	Not explicitly stated as acceptance criteria, but reported values are key performance indicators.	Serum/Plasma: 0.11 mg/dl - 16.95 mg/dlUrine: 3.56 mg/dl - 175 mg/dl
Upper Linearity Limit	Not explicitly stated as acceptance criteria, but reported values are key performance indicators.	Serum/Plasma: 16.95 mg/dl (50.85 mg/dl with auto post-dilution)Urine: 175 mg/dl (525 mg/dl with auto post-dilution)
Correlation	High correlation (r²) close to 1 with predicate (or reference) method.	Serum/Plasma (n=153): Y = 1.00 x + 0.00 (mg/dl) with r² = 0.999.Urine (n=105): Y = 0.97 x - 0.33 (mg/dl) with r² = 0.9982.
Calibration Stability	Serum/Plasma: 14 daysUrine: 14 days	Serum/Plasma: 14 daysUrine: 14 days
Reagent Stability	Closed: 18 months at 2-8°COn-board: 30 days	Closed: 18 months at 2-8°COn-board: 30 days

For the calibrators (ABX PENTRA Multical) and controls (ABX PENTRA N Control, ABX PENTRA P Control, ABX PENTRA Urine Control L/H), the acceptance criteria relate to their stability (closed and open vial) and their ability to ensure optimal calibration and control of the methods. The document reports specific stability periods for each.

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

Test Set Sample Size:
- For Correlation testing (Creatinine CP reagent):
  - Serum/Plasma: n=153
  - Urine: n=105
- The sample sizes for other performance metrics (detection limit, limit of quantitation, accuracy, precision, measuring range, linearity, stability) are not explicitly stated in the provided text. They are summarized, but the number of unique samples used to establish these values is not detailed.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

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

This information is not applicable to this type of device and study. The device is a clinical chemistry reagent for quantitative determination, not a diagnostic imaging or AI device requiring expert interpretation for ground truth establishment. The ground truth here would be established by a reference method (the predicate device K070383 for Creatinine) or a recognized laboratory standard.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., radiologists interpreting images) to resolve discrepancies and establish a consensus ground truth. For a quantitative chemical assay, the comparison is against an established reference method.

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 to this type of device and study. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic interpretation, which is not the function of a clinical chemistry reagent.

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

This information is not applicable in the context of an algorithm in the AI sense. This device is a reagent system that performs quantitative chemical analysis. The performance data presented (accuracy, precision, correlation, etc.) is the standalone performance of the reagent system on the analyzer, without human interpretation as a performance metric.

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

For the Creatinine CP reagent, the ground truth for performance evaluation (specifically correlation) would have been established by comparing the results obtained using the new device against results from a legally marketed predicate device (K070383) or a recognized reference method. The "Y = 1.00 x + 0.00 (mg/dl)" correlation equations suggest a comparison against a reference method, where 'x' represents the reference method's result.

For the calibrators and controls, the "assigned values" for their components are the ground truth, ensuring optimal calibration and control. These values are established through rigorous testing and standardization, often traceable to international reference materials.

8. The Sample Size for the Training Set

This information is not explicitly provided in the summary. For a medical device like a chemical reagent, the "training set" concept is not directly analogous to machine learning. However, the development and optimization of the reagent formulation and methods would involve extensive internal testing using numerous samples to establish the assay's characteristics before formal validation studies. The provided summary focuses on the validation data.

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

As mentioned in point 8, the concept of a "training set" and its "ground truth" establishment isn't directly applicable in the same way as AI/ML devices. For a chemical reagent, the development process would involve:

Reference Methods: Using established, highly accurate reference methods or certified reference materials to determine the true values of analytes in samples used during development.
Standardization: Developing and refining the assay chemistry to consistently achieve accurate and precise measurements against these reference values.
Specifications: Establishing performance specifications based on clinical requirements and comparison to existing, cleared methods.

Summary

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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 : _ K 110137____

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

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

Date Prepared: 26th July 2011

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: Common or Usual Name: Device Class Classification Name: Product Code:

Trade/Proprietary Name: Common or Usual Name:

ABX PENTRA Enzymatic Creatinine CP

Creatinine Class II §862.1225 : Creatinine Test System JFY ; Enzymatic Method Creatinine

CALIBRATORS:

Device Class Classification Name:

Product Code: CONTROLS :

Device Class

Product Code:

Classification Name:

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)

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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 Enzymatic CreatinineCP	K070383
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.

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Discussion of Performance Data:

ABX PENTRA Enzymatic Creatinine CP :
Sample type	Serum, Plasma and Urine
Detection limit	Serum/Plasma : 0.026 mg/dlUrine : 0.66 mg/dl
Limit of Quantitation	Serum/Plasma : 0.11 mg/dlUrine : 1.71 mg/dl
Accuracy and Precision	Serum/Plasma CV Total < 4.12%Urine CV Total < 4.84%
Measuring range	Serum/Plasma : 0.11 mg/dl - 16.95 mg/dlUrine : 3.56 mg/dl - 175 mg/dl
Upper linearity limit	Serum/Plasma : 16.95 mg/dl, and with automatic post-dilution :50.85 mg/dlUrine : 175 mg/dl, and with automatic post-dilution : 525 mg/dl
Correlation	Serum/Plasma (n=153) : Y = 1.00 x + 0.00 (mg/dl) with r2 =0.999.Urine (n=105) : Y = 0.97 x - 0.33 (mg/dl) with r2 = 0.9982.
Calibration stability	Serum/Plasma : 14 daysUrine : 14 days
Reagent stability	closed stability: 18 months at 2-8°Con-board stability : 30 days

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CALIBRATOR

ABX PENTRA Multical:
Analytes	Already cleared(K052007, K060205, K060318,K060325, K060854, K062180,K062737, K060434, K072115)	Included in this submission
Alkaline phosphatase	√	√
Alanine aminotransferase	√	√
Amylase	√	√
Aspartate aminotransferase	√	√
Creatine kinase	√	√
GGT	√	√
LDH	√	√
Lipase	√	√
Albumin	√	√
Direct Bilirubin	√	√
Total Bilirubin	√	√
Calcium	√	√
Cholesterol	√	√
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 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°CExceptionsDirect Bilirubin3 hours at 15°C to 25°C8 hours at 2°C to 8°C2 weeks at -25°C to -15°C
	Total Bilirubin
ABX PENTRA Multical:	6 hours at 15°C to 25°C
	1 day at 2°C to 8°C
	2 weeks at -25°C to -15°C

HORIBA ABX SAS, FRANCE

: :

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CONTROLS

ABX PENTRA N Control:
Analytes	Already cleared(K052007, K060205, K060318,K060325, K060854, K062180,K062737, K060434, K072115)	Included in this submission
Alkaline phosphatase	ﮨﮯ	イ
Alanine aminotransferase	V	イ
Amylase	ﮨﮯ	イ
Aspartate aminotransferase	1	l
Creatine kinase	4	-4-
GGT	N	ﮩﮯ
LDH	ﮨﮯ	イ
Lipase	ﮨﮯ	ゾ
Albumin	V	- ﻳﻌ
Direct Bilirubin	1	ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
Total Bilirubin	4	ﮨﮯ
Calcium	ﭩﮯ	્રી
Chloride	V	ﮨﮯ
Cholesterol	4	イ
HDL	N	イ
LDL	4	ﯿﮯ
Creatinine 120	4	ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
Enzymatic Creatinine		ﮨﮯ۔
Glucose HK	ﮨﮯ	ﮨﯿﮟ ﮨﮯ ﮨﯿﮟ ﮨﯿﮟ ﮨﯿﮟ ﮨﯿﮟ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﯽ ﻣﺠﻤﻮﻋﯽ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﻣﯿﮟ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﻣﯿﮟ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﻣﯿﮟ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ
Glucose PAP	ﮯ	ﺮ
Iron	ﮯ	イ
Lactic acid	ﮯ	イ
Magnesium	V	ﺮﯾﻤ
Phosphorus	ﮯ	ﮯ۔
Potassium	2	イ
Sodium	V	ಗ
Total Protein	1	ど
Total Protein 100	4	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Triglycerides	ﮨﮯ	ど
Urea / Blood Urea Nitrogen	1	-4
Uric acid	t	イ
/ .Lyophilized human serum with chemical additives and materialsFormat
of biological origin

HORIBA ABX SAS, FRANCE

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ABX PENTRA N Control:
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

(

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ABX PENTRA P Control:
Analytes	Already cleared(K052007, K060205, K060318,K060325, K060854, K062180,K062737, K060434, K072115)	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	√	√
Enzymatic Creatinine		√
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
ABX PENTRA P 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

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ABX PENTRA Urine Control L/H:
Analytes	Already cleared (K07249,K072115)	Included in this submission
Amylase	√	√
Calcium	√	√
Creatinine 120	√	√
Enzymatic Creatinine		√
Phosphorus	√
Glucose	√	√
Urea / Blood Urea Nitrogen	√	√
Uric acid	√
Urinary proteins	√	√
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

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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i i DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a human figure.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

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

AUG 1 0 2011

Re: K110137

Trade Name: ABX PENTRA Enzymatic Creatinine CP, 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: JFY, JIX, JJY Dated: June 28, 2011 Received: June 30, 2011

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 Aci 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 Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

G.C.

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

: 上一

Enclosure

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510(k) Number (if known):

Device Name: New Enzymatic Creatinine 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)

Ruth Cheb

510(k) K110137

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K110137 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)

Ruta Chube

510(k) K110137

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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 (OIVD)

Ruth Chusler

510(k) K110137

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KII0137

510(k) Number (if known):

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)

Rutt Chealer

510(k) K110637

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KII0137 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 (OIVD)

Rutt Chelen

510(k) K110137

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.