The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension® clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.

Device Description

The Dimension® ECRE Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension® Clinical Chemistry System. The reagents contained in the Dimension® ECRE Flex® reagent cartridge are: Reagent 1 - TAPS buffer, creatinase, sarcosine oxidase, HTIB; Reagent 2 - TAPS buffer, creatininase, horseradish peroxidase, 4-aminophenazon, and potassium hexacyanoferrate (II).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dimension® Enzymatic Creatinine (ECRE) Flex® Reagent Cartridge (DF270), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantitative sense as distinct thresholds that were met. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance is assessed through comparative testing with the predicate device.

However, based on the comparative table and the assertion of "substantial equivalent performance," we can infer the targeted performance characteristics by looking at the predicate device's typical performance (which is not detailed here beyond the measuring range) and the new device's reported characteristics.

Feature	Acceptance Criteria (Inferred from Predicate/Equivalence)	Reported Device Performance (Dimension® ECRE Flex®)
Intended Use	Quantitative measurement of creatinine for diagnosis/treatment of renal diseases, monitoring dialysis, and as a calculation basis for other urine analytes.	Quantitative measurement of creatinine for diagnosis/treatment of renal diseases, monitoring dialysis, and as a calculation basis for other urine analytes.
Sample Type	Human serum, plasma, and urine.	Plasma, serum, and urine.
Measuring Range	0.03 - 30 mg/dL	0.03 - 20.00 mg/dL
Sample Size	6 µL	6 µL
Measurement Type	Bichromatic end point	Bichromatic end point

Note: The measuring range of the new device (0.03 - 20.00 mg/dL) is narrower than the predicate (0.03 - 30 mg/dL). While this might typically be a point of divergence, the FDA's clearance implies that this difference was considered acceptable for substantial equivalence, perhaps because the narrower range is still clinically acceptable or covers the vast majority of relevant clinical values, and no specific acceptance criteria for the range were provided. The document states a "comparison of the important similarities and differences" and concludes "substantial equivalent performance."

2. Sample size used for the test set and the data provenance:

Sample Size for the Test Set: Not explicitly stated. The document mentions "Comparative testing described in the protocol included in this submission," but doesn't provide the number of samples or subjects used in this testing.
Data Provenance: Not explicitly stated (e.g., country of origin). The document provides no information about whether the data was retrospective or prospective.

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 document. For in-vitro diagnostic devices like this, "ground truth" is typically established by reference methods or established clinical laboratory practices, not by expert consensus in the way it might be for image analysis or clinical assessments. The comparison is made against the predicate device, implying that the predicate's performance serves as the benchmark.

4. Adjudication method for the test set:

This information is not provided. Given the nature of a chemical assay, adjudication by multiple experts is not a standard practice for establishing a single "ground truth" value for creatinine concentration. The performance is likely assessed by comparing results directly against a reference method or the predicate device.

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 to this device. An MRMC study is relevant for AI systems that assist human readers in tasks like image interpretation. The Dimension® ECRE Flex® Reagent Cartridge is an in-vitro diagnostic (IVD) assay designed to directly measure a chemical analyte (creatinine) in biological samples, not to assist human readers in interpretation.

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

This is not applicable in the context of an IVD reagent cartridge. The "algorithm" here is the chemical reaction and measurement process performed by the Dimension clinical chemistry system using the reagent. The performance of the system (reagent + instrument) is inherently standalone in that it provides a quantitative result directly without human interpretation influencing the measurement itself.

7. The type of ground truth used:

The "ground truth" for evaluating this device would implicitly be results obtained from a legally marketed predicate device (Roche's Creatinine Plus Reagent) or a recognized reference method for creatinine measurement. The document states: "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance [to the predicate]."

8. The sample size for the training set:

This information is not provided. For a chemical reagent, the "training set" concept is not analogous to machine learning. Instead, the reagent formulation and assay parameters are developed and optimized through extensive R&D and analytical validation experiments. The document does not detail the number of samples used in this development and optimization phase.

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

This information is not provided. Similar to point 8, the concept of "ground truth" for a training set in the context of an IVD reagent typically relates to the accuracy and precision established during the development and optimization phase, often by running samples with known creatinine concentrations (e.g., NIST traceable standards, patient samples quantified by a gold-standard reference method). The document does not describe these specific procedures.

Summary

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K073055

510(k) Summary of Safety and Effectiveness for the Dimension® Enzymatic Creatinine (ECRE) Flex® Reagent Cartridge (DF270)

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.

A. 510(k) Number:

B. Date of Preparation: October 24, 2007

JAN - 3 2008

C. Proprietary and Established Names:

Dimension® Enzymatic Creatinine (ECRE) Flex® Reagent Cartridge (DF270)

D. Applicant: Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Regulatory Affairs and Compliance Manager Office: (302) 631-0376 Fax: (302) 631-6299

E. Regulatory Information:

1. Regulation section: 21 CFR § 862.1225 Creatinine Test System
1. Classification: Class II
1. Product Code: JFY Enzymatic Method, Creatinine
1. Panel: Clinical Chemistry

F. Predicate Device:

The Dimension® ECRE Flex® reagent cartridge is substantially equivalent to Roche's Creatinine Plus Reagent (K003261).

G. Device Description:

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H. Intended Use: The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human scrum, plasma, and urine on the Dimension® clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.

I. Substantial Equivalence Information:

The Dimension® ECRE Flex® reagent cartridge and the predicate, Roche Creatinine Plus reagent were compared. A comparison of the important similarities and differences between the device and the predicates is provided in the following table:

Feature	Dimension® ECRE Flex®reagent cartridge	Creatinine Plus Reagent(K003261)
Intended Use	The ECRE method is an in vitrodiagnostic test for the quantitativemeasurement of creatinine in humanserum, plasma, and urine on theDimension® clinical chemistry system.Creatinine measurements are used inthe diagnosis and treatment of renaldiseases, in monitoring renal dialysis,and as a calculation basis for otherurine analytes.	Enzymatic in vitro assay for the directquantitative determination of creatinine inhuman serum, plasma and urine usingRoche clinical chemistry analyzers.
Sample Type	Plasma, serum, and urine.	Human serum, plasma and urine.
MeasuringRange	0.03 -20.00 mg/dL	0.03 - 30 mg/dL
Sample Size	6 [Mu]L	6 [Mu]L
Measurement	Bichromatic end point	Bichromatic end point

J. Conclusion:

The Dimension® ECRE Flex® reagent cartridge is substantially equivalent to Roche's Creatinine Plus Reagent (K003261). Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 3 2008

Dade Behring, Inc. Glasgow Business Community c/o Mr. Victor Carrio RA/QS Compliance Manager P.O. Box 6101, M/S 514 Newark, DE 19714-6101

Re: K073055

Trade/Device Name: Dimension Enzymatic Creatinine (ECRE) Flex Reagent Cartridge, Model DF270 Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system. Regulatory Class: Class II Product Code: JFY Dated: October 29, 2007 Received: October 30, 2007

Dear Mr. Carrio:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. 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 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

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Indications For Use Statement

510(k) Number (if known):

Device Name:

Dimension® ECRE Flex® Reagent Cartridge (DF270)

Indications for Use:

Sean Coope
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

51000 K073055

Prescription Use X (Per 21 CFR 801 Subpart D)

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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)

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.