CRE3 reagent, in conjunction with SYNCHRON CX® Delta Systems and SYNCHRON CX® Calibrators 1, 2 and 3 is intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine.

Device Description

The SYNCHRON CX Delta System determines creatinine concentration by means of the Jaffe rate method. A precise volume of sample is injected into the reaction cup with CRE3 reagent containing picric acid. Absorbance readings are taken at 520 nm between 19 to 25 seconds after sample introduction. The SYNCHRON CX Delta System utilizes a two level calibrator for the creatinine test. SYNCHRON CX Calibrator is designed for optimal performance on the SYNCHRON CX Delta Clinical Systems. CX Calibrator is an aqueous based calibrator made by New England Reagent Laboratory (NERL) to Beckman Coulter specifications, This product is tested during manufacturing using standards traceable to National Institute of Standard and Technology (NIST) reference materials. The creatinine concentrations are established based on addition of weighed-in specific quantities of creatinine to achieve the appropriate level of each calibrator. Each calibrator level is packaged individually in 25 mL bottles, 6 to a package.

AI/ML Overview

Here's an analysis of the provided text regarding the SYNCHRON CX Delta Clinical System, focusing on acceptance criteria and supporting studies:

It's important to note that the provided text is a 510(k) summary for a modification to an already legally marketed device (SYNCHRON CX Delta Clinical System, K950958). The modification specifically involves changing the calibrator set points for the creatinine module (CRE3) based on correlation to Isotope Dilution Mass Spectrometry (IDMS). This is not an initial clearance of a novel device, so the depth of performance data might differ from a completely new product.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria values (e.g., precision limits, bias limits, linearity ranges) in the provided sections. It broadly states that "Performance data from validation testing supports equivalency."

However, based on the context of a 510(k) for a calibrator set point change, the implicit acceptance criteria would be that the modified system's performance (specifically for creatinine measurement) remains substantially equivalent to the predicate device and meets established analytical performance standards for creatinine assays. These standards would typically involve accuracy, precision, linearity, and verification of the new calibration's impact.

While specific numbers are missing, the type of performance data implied by a calibrator change would include:

Acceptance Criteria Type (Implicit)	Reported Device Performance (Implied)
Accuracy/Bias (vs. IDMS)	Calibrator set points correlated to IDMS.
Equivalency to Predicate	"Performance data from validation testing supports equivalency."
Precision	(Not explicitly stated, but assumed to be maintained)
Linearity	(Not explicitly stated, but assumed to be maintained)
Interference	(Not explicitly stated, but assumed to be maintained)

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document mentions "a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectometry (IDMS)." It does not specify the sample size of this "sample set."
Data Provenance: Not specified.
Retrospective or Prospective: The "one-time correlation" suggests a retrospective analysis of an existing sample set, or a prospective collection specifically for this correlation study. The text does not definitively state.

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

Number of Experts: Not applicable in the traditional sense of human readers. The "ground truth" for the new calibrator set points was established by Isotope Dilution Mass Spectrometry (IDMS). IDMS is a highly accurate and precise analytical method often used as a reference method for clinical chemistry analytes.
Qualifications of Experts: N/A for human experts for ground truth establishment. The expertise lies in the IDMS methodology and instrument operators.

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

Adjudication Method: Not applicable. IDMS provides a direct, highly accurate measurement; there's no "adjudication" among multiple interpretations.

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 in vitro diagnostic (IVD) for quantitative measurement of creatinine, not an imaging or AI-assisted diagnostic tool requiring human reader studies.

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

Standalone Performance: Yes, the core of the evaluation involves the analytical performance of the SYNCHRON CX Delta Clinical System in measuring creatinine, with the new calibrator set points. This is inherently a "standalone" analytical performance assessment, as the device provides a quantitative result directly. The modification (calibrator set points) is applied to the algorithm/instrument's interpretation of the optical density readings.

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

Type of Ground Truth: Isotope Dilution Mass Spectrometry (IDMS) for the creatinine values used to establish the new calibrator set points. It's a gold standard reference method for creatinine determination.

8. The sample size for the training set

Not explicitly mentioned. The modification involved "value assignment of the creatinine levels to values determined by a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectometery (IDMS)." This "sample set" serves as the reference for setting the new calibration but the text doesn't differentiate it as a "training set" in the machine learning sense, nor does it specify the size.

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

The ground truth for the "sample set" (which functions as the reference for the new calibration and thus, implicitly, a form of "training") was established by Isotope Dilution Mass Spectrometry (IDMS) measurements.

Summary

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K071280

510(k) Summary

JUN - 1 2007

1.0 Submitted Bv:

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

2.0 Date Submitted

May 4, 2007

3.0 Device Name(s):

3.1 Proprietary Names
SYNCHRON® CX Delta Clinical System SYNCHRON® CX Calibrator 1, 2 &3

3.2 Classification Names

Creatinine test system (21 CFR § 862.1225) Calibrator, Multi-Analyte Mixutre (21 CFR § 862.1150)

4.0 Legally Marketed Device

The SYNCHRON CX Delta Clinical Systems, claims substantial equivalence to the Beckman Coulter SYNCHRON CX Delta Clinical System currently in commercial distribution, FDA 510(k) Number K950958.

5.0 Device Description

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Calibrator is designed for optimal performance on the SYNCHRON CX Delta Clinical Systems. CX Calibrator is an aqueous based calibrator made by New England Reagent Laboratory (NERL) to Beckman Coulter specifications, This product is tested during manufacturing using standards traceable to National Institute of Standard and Technology (NIST) reference materials. The creatinine concentrations are established based on addition of weighed-in specific quantities of creatinine to achieve the appropriate level of each calibrator. Each calibrator level is packaged individually in 25 mL bottles, 6 to a package.

6.0 Intended Use

CRE3 reagent, when used in conjunction with SYNCHRON CX® Delta System(s) SYNCHRON® Systems CX Calibrator 1 and 2. is intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine.

Beckman Coulter SYNCHRON CX Calibrators 1, 2, and 3 are to be used for calibrating SYNCHRON CX Delta, CX® CE, and CX PRO Systems only.

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

The modification to the creatinine module (CRE3) involves modification of the calibrator set points coded in the chemistry database. No formulation changes or system parameters have been modified with the exception of the calibrator set points. The modification to the CX Calibrator 1, 2 & 3 set points involves value assignment of the creatinine levels to values determined by a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectometery (IDMS). These new calibrator set points will replace the current values contained in the chemistry database. The product will continue to be manufactured in the same

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manner as it is today. The creatinine level in each calibrator will still be based on addition of weighed-in specific values of creatinine.

Summary of Performance Data 8.0

Performance data from validation testing supports equivalency.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

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

Re: K071280

Trade/Device Name: Synchron® CX Delta Clinical Systems Regulation Number: 21 CFR§ 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: CGX, JIX 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JUN - 1 2007

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 yours,

Jean M. Cooper, M.S., D.V.M.

Jean 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): K071280

SYNCHRON® CX Delta Clinical Systems, Creatinine Test Device Name: Systems

Indications for Use:

Beckman Coulter SYNCHRON CX Calibrators 1, 2, and 3 are to be used for calibrating SYNCHRON CX Delta, CX® CE, and CX PRO Systems only.

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.

1 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

Office of In Vitro Dlagr

510(k) K071382

Page 1 of 1

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.