The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista® 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.

The ECREA CAL is an in vitro diagnostic product for the calibration of the Enzymatic Creatinine (ECREA) method on the Dimension Vista® System.

Device Description

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

The Dimension Vista® ECREA CAL is an ECREA CAL is a liquid, bovine serum albumin, based product containing creatinine. The kit consists of six vials, three vials per level (A, B), 2.5 mL per vial.

AI/ML Overview

The provided document is a 510(k) Summary for the Siemens Healthcare Diagnostics Inc. Dimension Vista® Enzymatic Creatinine (ECREA) Flex® Reagent Cartridge and Calibrator. It establishes substantial equivalence by comparing the new device to previously cleared predicate devices. The document does not contain a detailed study proving the device meets general acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, or accuracy against an established ground truth in a standalone or MRMC study. Instead, it focuses on demonstrating analytical equivalence to predicate devices.

Therefore, many of the requested categories cannot be directly extracted from this specific document as they pertain to clinical validation studies, which are not detailed here.

Here's a breakdown of what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance targets (e.g., "sensitivity > 90%"). Instead, it focuses on demonstrating substantial equivalence to a predicate device through comparative testing. The performance is reported in terms of the results of this comparative testing, but the specifics of that performance (e.g., regression statistics, bias, precision) are not provided in this summary. It states "Comparative testing described in the submission report demonstrates substantial equivalent performance," implying that the results met the criteria for equivalence.

Feature	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Summary Statement)
Analytical Performance (e.g., accuracy, precision to predicate)	Performance comparable to Roche Creatinine Plus Reagent (K003261)	"Comparative testing described in the submission report demonstrates substantial equivalent performance."
Analytical Performance (Calibrator)	Performance comparable to Dimension® Chem I CAL (DC18B) (K860021)	"Comparative testing described in the submission report demonstrates substantial equivalent performance."
Measuring Range (Serum, Plasma)	Similar to predicate (0.03 - 30 mg/dL)	0.14 - 20.0 mg/dL (Note: This is a direct comparison point, not an acceptance criteria from the text, but shows how it compares to predicate's range)
Measuring Range (Urine)	Similar to predicate (0.3 - 400 mg/dL)	2.80 - 400 mg/dL (Similar note as above)

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

This information is not provided in the 510(k) summary. The summary refers to "comparative testing described in the submission report," implying that a test set was used, but details on sample size, country of origin, or retrospective/prospective nature are absent.

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 submission. For an in vitro diagnostic (IVD) device like a creatinine assay, the "ground truth" is typically established by reference methods or clinical outcomes, not by expert consensus on images or clinical assessments.

4. Adjudication Method for the Test Set

Not applicable. As this is an IVD device measuring an analyte, there isn't typically an "adjudication method" in the sense of multiple experts reviewing and reaching consensus on a finding.

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 device is an enzymatic creatinine assay, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, implicitly. The performance of the Dimension Vista® ECREA Flex® reagent cartridge and calibrator system on the Dimension Vista® System is presented as a standalone analytical device. There is no human-in-the-loop component for the measurement itself.

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

The document does not explicitly state the "ground truth" used for validation. However, for a creatinine assay, the ground truth for an analytical validation of substantial equivalence typically refers to:

Results from the predicate device itself (for method comparison studies).
Traceability to a recognized reference method (e.g., isotope dilution mass spectrometry (IDMS)) and/or certified reference materials, although this level of detail is not in the summary.
The established accuracy and precision of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical reagent and calibrator system, not a machine learning or AI 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 for this device type.

Summary

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510(k) Summary of Safety and Effectiveness for the

Dimension Vista® Enzymatic Creatinine (ECREA) Flex® Reagent Cartridge

Dimension Vista® Enzymatic Creatinine (ECREA CAL) Calibrator

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: K090330 ____________

B. Date of Preparation: January 27, 2009

C. Proprietary and Established Names:

Dimension Vista® Enzymatic Creatinine Flex® Reagent Cartridge

Dimension Vista® Enzymatic Creatinine Calibrator

D. Applicant:

Siemens Healthcare Diagnostics Inc.

P.O. Box 6101, Newark, DE 19714-6101

Rose T. Marinelli, Regulatory Technical Specialist

Office Number: (302) 631-8805 Fax Number: (302) 631-6299

E. Regulatory Information:

Dimension Vista® ECREA Flex® Reagent Cartridge:

Requlation section: 21 CFR § 862.1225 Creatinine Test System

1. Classification: Class II
1. Product Code: JFY Enzymatic Method, Creatinine
1. Panel: Clinical Chemistry

Dimension Vista® ECREA CAL:

Regulation section: 21 CFR § 862.1150 Calibrator

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1. Classification: Class II
1. Product Code: JIT Calibrator, Secondary
1. Panel: Clinical Chemistry

F. Predicate Device:

The predicate device used to demonstrate substantial equivalence to the Dimension Vista® ECREA Flex® reagent cartridge is the Roche Creatinine Plus Reagent previously cleared under K003261.

The predicate device used to demonstrate substantial equivalence to the Dimension® Chem I Cal (DC18B) previously cleared under K860021.

G. Device Description:

The Dimension Vista® ECREA CAL is an ECREA CAL is a liquid, bovine serum albumin, based product containing creatinine. The kit consists of six vials, three vials per level (A, B), 2.5 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.

H. Intended Use:

The ECREA CAL is an in vitro diagnostic product for the calibration of the Enzvmatic Creatinine (ECREA) method on the Dimension Vista® System.

l. Substantial Equivalence Information:

The Dimension Vista® ECREA Flex® reagent cartridge and the predicate, Roche Creatinine Plus reagent, were compared. The following table provides a comparison of the important similarities and differences:

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Feature	Dimension Vista® ECREAFlex® reagent cartridge	Creatinine Plus Reagent(K003261)
Intended Use	The ECREA method is an in vitrodiagnostic test for the quantitativemeasurement of creatinine inhuman serum, plasma, and urineon the Dimension Vista® System.Creatinine measurements are usedin the diagnosis and treatment ofrenal diseases, in monitoring renaldialysis, and as a calculation basisfor other urine analytes.	Enzymatic in vitro assay for thedirect quantitative determination ofcreatinine in human serum, plasmaand urine using Roche clinicalchemistry analyzers.
Sample Type	Plasma, serum, and urine	Plasma, serum and urine
MeasuringRange	Serum, Plasma - 0.14 - 20.0 mg/dLUrine - 2.80 - 400 mg/dL	Serum, Plasma - 0.03 - 30 mg/dLUrine - 0.3 - 400 mg/dL
Sample Size	2.7 µL	6 µL
Measurement	Bichromatic end point	Bichromatic end point

The Dimension Vista® ECREA CAL and the predicate, Dimension® Chem I CAL (DC18B), were compared. The following table provides a comparison of the important similarities and differences:

Feature	ECREA CAL	Dimension® Chem I CAL(DC18B) K860021
IntendedUse	The ECREA CAL is an in vitrodiagnostic product for thecalibration of the EnzymaticCreatinine (ECREA) method onthe Dimension Vista® System.	The Dimension® Chemistry ICalibrator is an in vitro diagnosticproduct to be used to calibrate theDimension® clinical chemistrysystem for the Calcium (CA),Creatinine (CREA/ECRE),Glucose (GLU/GLUC), UreaNitrogen (BUN), and Uric Acid(URCA) methods.
Analyte	Creatinine	Calcium, Creatinine, Glucose,Urea Nitrogen, Uric Acid
Matrix	Bovine Albumin	Bovine Albumin
Form	Liquid	Lyophilized
Volume	Six vials, three vials per level (A,B), 2.5 mL per vial.	Six vials, two vials per level (1, 2,3), 2.0 mL per vial
Levels	Three levels: 0.0, 0.95, 22.0mg/dLLevel 1 is System Water	Three levels: 0.0, 11.1, 22.4 mg/dL

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J. Conclusion:

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

The Dimension Vista® ECREA CAL is substantially equivalent to the Dimension® Chem I CAL CREA (K860021). Comparative testing described in the submission report demonstrates substantial equivalent performance.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics Inc. c/o Ms. Rose Marinelli PO Box 6101 MS 514 Newark, DE 19714-6101

MAY 22 2009

Re: K090330

Trade/Device Name: Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge and Dimension Vista Enzymatic Creatinine Calibrator Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: JFY and JIT Dated: April 24, 2009 Received: April 27, 2009

Dear Ms. Marinelli:

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 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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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 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 (240) 276-0450. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrl/mdr/.

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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

G.C.H.

Courtney C. Harper, Ph.D. Acting 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): KOQO330

Device Name:

Dimension Vista® Enzymatic Creatinine Flex® Reagent Cartridge

Indications for Use:

Prescription Use X (Per 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)

Division Sign-Off

Office of In Vitro Dlagn Device Evalue

510(k) K090330

Page 1 of 2

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Indications For Use Statement

14090330 510(k) Number (if known):

Device Name:

Dimension Vista® Enzymatic Creatinine Calibrator

Indications for Use:

The ECREA CAL is an in vitro diagnostic product for the calibration of the Enzymatic Creatinine (ECREA) method on the Dimension Vista® System.

Prescription Use X (Per 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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K090330

Page 2 of 2

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.