Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard in vitro diagnostic test for creatinine measurement using enzymatic reactions and a calibration product. There is no mention of AI, ML, or any computational methods beyond standard analytical processing.

Therapeutic

No.
The device is an in vitro diagnostic test used for the quantitative measurement of creatinine, which aids in the diagnosis and treatment of renal diseases but does not directly treat the patient.

Diagnostic

Yes

The ECREA method is explicitly stated to be "an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine." It also mentions that "Creatinine measurements are used in the diagnosis and treatment of renal diseases."

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical reagents (liquids, buffers, enzymes) contained within a cartridge, which are hardware components. The device is an in vitro diagnostic test method, not a software application.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use / Indications for Use: The very first sentence explicitly states, "The ECREA method is an in vitro diagnostic test..." and "The ECREA CAL is an in vitro diagnostic product...". This is the most direct confirmation.
Device Description: The description of the reagent cartridge also refers to it as a "prepackaged in-vitro diagnostic test method".
Purpose: The intended use describes the measurement of creatinine in human samples (serum, plasma, urine) for the diagnosis and treatment of renal diseases, monitoring dialysis, and as a basis for other calculations. This aligns perfectly with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

JFY, JIT

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. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Comparative testing described in the submission report demonstrates substantial equivalent performance.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K003261, K860021

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

1

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 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. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.

H. Intended Use:

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 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® ECREA
Flex® reagent cartridge | Creatinine Plus Reagent
(K003261) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | Enzymatic in vitro assay for the
direct quantitative determination of
creatinine in human serum, plasma
and urine using Roche clinical
chemistry analyzers. |
| Sample Type | Plasma, serum, and urine | Plasma, serum and urine |
| Measuring
Range | Serum, Plasma - 0.14 - 20.0 mg/dL
Urine - 2.80 - 400 mg/dL | Serum, Plasma - 0.03 - 30 mg/dL
Urine - 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 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The ECREA CAL is an in vitro
diagnostic product for the
calibration of the Enzymatic
Creatinine (ECREA) method on
the Dimension Vista® System. | The Dimension® Chemistry I
Calibrator is an in vitro diagnostic
product to be used to calibrate the
Dimension® clinical chemistry
system for the Calcium (CA),
Creatinine (CREA/ECRE),
Glucose (GLU/GLUC), Urea
Nitrogen (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, 22.0
mg/dL
*Level 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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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 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:

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.

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

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