The Beckman Coulter AQUA CAL 1, 2, and 3 are intended for use on SYNCHRON LX® and UniCel® DxC Systems for the calibration of Sodium, Potassium, Chloride, Urea Nitrogen, Urea, Glucose Creatinine, Calcium, Carbon Dioxide, and Phosphorus.

CREm reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System 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 LX20 System determines creatinine concentration by means of the Jaffe rate method. A precise volume of sample is injected into the reaction cup with CREm reagent containing picric acid. Absorbance readings are taken at 520 nm between 19 to 25 seconds after sample introduction. The SYNCHRON LX20 System utilizes a two level calibrator for the creatinine test. Beckman Coulter AQUA Cal is designed for optimal performance on the SYNCHRON LX20 Clinical and UniCel DxC Svstems. AQUA Cal 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

The provided text is a 510(k) Summary for a modification to the SYNCHRON® LX20 Clinical System, specifically concerning the creatinine measurement. It describes the device, its intended use, and a comparison to a predicate device, focusing on the change to calibrator set points.

However, the summary does not contain acceptance criteria or detailed study data proving the device meets acceptance criteria. It states "Performance data from validation testing supports equivalency" but does not elaborate on what that data is, what the acceptance criteria were, or the specifics of the study design.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the document:

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

Acceptance Criteria: Not explicitly stated in the provided text.
Reported Device Performance: Not explicitly stated in the provided text, beyond "Performance data from validation testing supports equivalency."

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: Not specified. The document mentions "a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectrometry (IDMS)", but the size of this set is not provided.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This is not applicable as the ground truth was established by Isotope Dilution Mass Spectrometry (IDMS), a reference method, not by expert consensus. Even if experts were involved in the IDMS process, their number and qualifications are not mentioned.

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

Not applicable as the ground truth was established by IDMS, not human adjudication.

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) system for quantitative determination of creatinine, not an imaging device or an AI application with human readers.

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

Yes, the performance of the SYNCHRON® LX20 Clinical System is inherently standalone, as it's an automated analyzer. The "modification to the creatinine module (CREm) involves modification of the calibrator set points coded in the chemistry database." The performance evaluation would be of the instrument's accuracy and precision against the IDMS reference method. However, the details of this standalone performance data are not provided.

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

Ground Truth Type: Isotope Dilution Mass Spectrometry (IDMS). This is a highly accurate and precise analytical technique often used as a reference method for determining the true concentration of substances in biological samples.

8. The sample size for the training set:

Not applicable. This device is a modification of an existing IVD system, and the change is to calibrator set points based on a "one time correlation" to IDMS. It's not a machine learning model that typically has a distinct training set. If 'training' refers to the set used to establish the new calibrator set points, its size is not provided.

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

The new calibrator set points were "value assigned... to values determined by a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectrometry (IDMS)." This indicates IDMS was used to establish the "ground truth" (reference values) for the samples that informed the new calibrator set points.

Summary

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510(k) Summary

1.0 Submitted By:

. 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

JUN - 1 2007

2.0 Date Submitted

May 4, 2007

3.0 Device Name(s):

3.1 Proprietary Names
SYNCHRON® LX20 Clinical System
Classification Names 3.2
Creatinine test system (21 CFR § 862.1225)

4.0 Legally Marketed Device

The SYNCHRON LX20 Clinical Systems, claims substantial equivalence to the Beckman Coulter SYNCHRON LX20 Clinical System currently in commercial distribution, FDA 510(k) Number K965240.

5.0 Device Description

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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

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

The modification to the creatinine module (CREm) 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 AQUA Cal 1, 2 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 manner as it is today. The creatinine level in each calibrator will still be based on addition of weighed-in specific values of creatinine.

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 consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circular border.

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: K071277

Trade/Device Name: Synchron® LX20 Clinical Systems Regulation Number: 21 CFR8 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.

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.

Yéan 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):

K071277

SYNCHRON® LX20 Clinical Systems, Creatinine Test Device Name: Systems

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.

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 Diagnostic vice Evaluation and Safety

510(k) K071397

Page 1 of 1

Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON Systems Creatinine Reagent File: LX CREm AquaCal s510k.doc, May 2007

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.