CREA reagent, when used in conjunction with UniCel® DxC 600/800 System(s), SYNCHRON® Systems Multi Calibrator and the CRTX Application Sheet, is intended for the quantitative determination of Creatinine concentration in human serum or plasma as a User Defined Reagent (UDR) application.

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.

Device Description

The SYNCHRON Systems Creatinine (CREA) reagent is designed for optimal performance on SYNCHRON CX and UniCel DxC SYNCHRON instrument models. The reagent kit contains two 300-test cartridges that are packaged separately from the associated calibrator.

The candidate CRTX User Defined application is designed for optimal use on UniCel DxC Systems as a sample-blanked method to reduce bilirubin interference in serum and plasma samples.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modification to the SYNCHRON Systems Creatinine Reagent. This submission mainly focuses on the intended use, device description, and a comparison to the predicate device, emphasizing the reduction of bilirubin interference.

However, the document does not contain the specifics needed to completely fill out the acceptance criteria and study details as requested in the prompt. It states "Performance data from verification testing supports equivalency" but does not elaborate on the details of this testing.

Therefore, many sections of your request cannot be fully answered from the provided text. I will fill in what information is available and indicate where information is missing.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission states "Performance data from verification testing supports equivalency," but does not list specific acceptance criteria or quantitative performance results (e.g., accuracy, precision, linearity, interference studies with specific values).

Acceptance Criteria	Reported Device Performance
Not provided	Not provided

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

Sample size for the test set: Not provided.
Data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is a reagent for diagnostic testing (Creatinine concentration). The "ground truth" for chemical assays like this is typically established through reference methods, certified standards, and analytical validation (e.g., comparison to a predicate, linearity studies). The concept of "experts" in the context of image interpretation (like radiologists) does not directly apply here. Therefore, this information is not relevant in the same manner as for AI-driven image analysis devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for this type of in vitro diagnostic device focused on chemical assay performance. Adjudication methods are typically used in studies involving human interpretation, often in imaging or clinical decision scenarios.

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:

No, an MRMC study was not done/is not applicable. This device is an in vitro diagnostic reagent, not an AI-driven interpretation tool intended to assist human readers.

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

As an in vitro diagnostic reagent, the device itself provides a quantitative measurement. The "standalone" performance, in this context, refers to its analytical performance characteristics (accuracy, precision, linearity, interference, etc.). The document indicates "Performance data from verification testing supports equivalency" but does not provide the specific results of these standalone performance metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For a chemical assay, the "ground truth" would be established using reference methods or certified reference materials to determine the true concentration of creatinine in samples. The document does not explicitly state the methodology used to establish the ground truth for their verification testing, but this is the standard approach for such devices.

8. The sample size for the training set:

Not applicable/Not provided. This is a chemical reagent, not a machine learning algorithm that requires a "training set" in the conventional sense of AI development.

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

Not applicable/Not provided for the same reasons as #8.

Summary

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L0600935

510(k) SUMMARY

1.0 Submitted By:

2002 8 2000

Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123

2.0 Date Submitted

April 4, 2006

3.0 Device Name(s):

3.1 Proprietary Names SYNCHRON Systems Creatinine Reagent
3.2 Classification Names [862.1225 Creatinine test system]

4.0 Legally Marketed Device

SYNCHRON Systems Creatinine Reagent claims substantial The equivalence to the SYNCHRON Systems Creatinine Reagent currently in commercial distribution. FDA 510(k) Number K042291.

5.0 Device Description

The candidate CRTX User Defined application is designed for optimal use on UniCel DxC Systems as a sample-blanked method to reduce bilirubin interference in serum and plasma samples.

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6.0 Intended Use

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.

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

The creatinine-triggered assay offers an alternative parameter set designed to work with the existing SYNCHRON Creatinine Reagent. The creatinine-triggered reagent application effectively reduces the interference seen with bilirubin when using the creatinine assay for serum and plasma samples. The creatinine-triagered assay uses a reaction trigger cycle employed for sample blanking. Use of the trigger cycle will reduce the sample throughput when compared to the system bar-coded creatinine assay.

8.0 Summary of Performance Data

Performance data from verification 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 wing-like shapes, symbolizing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 8 2006

Ms. Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. M/S W-110, PO Box 8000 Brea, CA 92822-8000

Re: K060935

Trade/Device Name: SYNCHRON® Systems Creatinine (CREA) Reagent Regulation Number: 21 CFR§ 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: CGX Dated: April 4, 2006 Received: April 5, 2006

Dear Ms. Hellie:

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 Ivqally 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) 276-0484. Also, please other 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 tolloffree miber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez

Alberto Gutierrez, Ph.D. 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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page 1 of 1

510(k) Number (if known): K060935

SYNCHRON® Systems Creatinine (CREA) Reagent Device Name:

Indications for Use:

CREA reagent, when used in conjunction with UniCel® DxC 600/800 System(s), and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or 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.

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)

Carol C. Benson

ty
K060935

Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON® Systems Creatinine Reagent File: CTRX s510k supplement.doc, 3/06

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.