CR-S reagent, when used in conjunction with UniCel® DxC 600/800 System(s) and SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine.

Device Description

The SYNCHRON Systems CR-S Reagent is designed for optimal performance on the SYNCHRON UniCel DxC (UniCel DxC 600, DxC 800, UniCel DxC 600i) Systems. The reagent kit contains two 300-test cartridges, and is packaged separately from the associated calibrators.

AI/ML Overview

The provided 510(k) summary for the SYNCHRON® Systems Creatinine Reagent (K071283) does not contain detailed information regarding acceptance criteria, specific performance metrics, or a comprehensive study report with sample sizes, ground truth establishment, or expert involvement as typically found in studies for AI-powered diagnostic devices.

This document describes a modification to an existing creatinine reagent and focuses on demonstrating substantial equivalence to the predicate device, rather than providing a detailed clinical study for a novel device. The modification primarily involves changes in system parameters and calibration methodology.

Therefore, many of the requested categories cannot be fully addressed from the provided text.

Here's the information that can be extracted or reasonably inferred from the document, along with an explanation of why other requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Performance data from validation testing supports equivalency." However, it does not provide a table of specific acceptance criteria or quantitative reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision data, limits of detection, linearity ranges that would typically be detailed in a robust study report). It only broadly claims that the data "supports equivalency."

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

This information is not provided in the document. The filing focuses on the modification of a reagent, not a clinical study involving a "test set" in the context of AI device evaluation.

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

This information is not provided and is not applicable in the context of a chemical reagent modification. Ground truth, in the AI diagnostic sense, would refer to definitive diagnoses or measurements established by human experts or gold standard methods for comparison with AI output. For a creatinine reagent, performance is typically assessed against established analytical methods traceable to international standards (like IDMS mentioned for calibrator material).

4. Adjudication Method for the Test Set

This information is not provided and is not applicable for a chemical reagent modification. Adjudication methods (e.g., 2+1, 3+1) are common in AI diagnostic image reading studies where human readers resolve discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

An MRMC study was not performed. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a chemical reagent.

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

This concept is not applicable to a chemical reagent test. "Standalone performance" refers to the algorithm's performance without human interaction, a concept for AI diagnostics, not for a laboratory reagent. The device itself (the reagent in combination with the analyzer) is designed to perform the measurement quantitatively.

7. The Type of Ground Truth Used

The document alludes to the traceability of calibrator values to "Isotope Dilution Mass Spectrometry (IDMS) for creatinine recovery." IDMS is a highly accurate and precise analytical method often considered a "gold standard" for creatinine measurement. While this isn't "ground truth" in the AI diagnostic sense, it suggests that the calibration and potentially the accuracy validation of the reagent would be referenced against this highly accurate analytical method.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. Chemical reagents are not "trained" in the machine learning sense. Their performance is inherent in their chemical composition and reaction kinetics when used with the specified analytical system.

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

This information is not provided and is not applicable. As stated above, chemical reagents are not "trained" using a "training set" with established ground truth in the way an AI algorithm is. Their accuracy and performance are established through rigorous analytical validation studies.

In summary:

The provided document, a 510(k) summary for a reagent modification, focuses on demonstrating substantial equivalence through analytical performance data, not a clinical study involving experts, test sets for AI evaluation, or ground truth establishment in the context of diagnostic imaging. Therefore, most of the requested information pertinent to AI device evaluation is not present. The key takeaway is that the device's performance data "supports equivalency" to a predicate device, and its calibrator values are traceable to IDMS, indicating a high level of analytical accuracy reference.

Summary

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510(k) Summary

K071283

1.0 Submitted By:

JUN - 1 2007

Tara M. Viviani Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000 Telephone: (714) 961-3626 FAX: (714) 961-4123

Date Submitted 2.0

May 4, 2007

3.0 Device Name(s):

3.1 Proprietary Names
SYNCHRON® Systems Creatinine Reagent

3.2 Classification Names

Creatinine test system (21 CFR § 862.1225)

4.0 Legally Marketed Device

The SYNCHRON Systems Creatinine (CR-S) Reagent claims substantial equivalence to the Beckman Coulter SYNCHRON Systems Creatinine (CREA) reagent currently in commercial distribution, FDA 510(k) Number K042291.

5.0 Device Description

Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON Systems Creatinine Reagent File: CR-S s510k.doc

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6.0 Intended Use

CR-S reagent, when used in conjunction with UniCel® DxC 600/800 System(s) and SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or urine.

7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)

The modification to the SYNCHRON Systems CREA assay involves duplication of the system parameters under the acronym CR-S. The calibration methodology will be modified from a single point linear method with a fixed intercept using CX Multical (serum matrix) to a two point linear calibration using AQUA CAL on 1 and 2 (aqueous matrix) on UniCel DxC systems. Values assigned to the calibrator material are traceable to Isotope Dilution Mass Spectometry (IDMS) for creatinine recovery.

8.0 Summary of Performance Data

Performance data from validation testing supports equivalency.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Beckman Coulter, Inc. c/o Ms. Tara M. Viviani, Senior Regulatory Affairs Specialist 200 South Kraemer Blvd., M/S W-110 Brea, CA 92821

JUN - 1 2007

Re: K071283

Trade/Device Name: Synchron® Systems Creatinine Reagent Regulation Number: 21 CFR§ 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: CGX Dated: May 04, 2007 Received: May 07, 2007

Dear Ms. Viviani:

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. Iisting 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

510(k) Number (if known): K01

Device Name: SYNCHRON® Systems Creatinine Reagent

Indications for Use:

Clinical Significance:

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.

ﺪ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 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

Division Sign

Office of In Vitro Diagnostic Device Evaluation and

510(k) K071203

Page 1 of 1

Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON Systems Creatinine Reagent File: CR-S s510k.doc

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.