The Access Estradiol Calibrators are intended to calibrate the Access Estradiol assay for the quantitative determination of estradiol levels in human serum and plasma using the Access Immunoassay Systems.

Device Description

The Access Estradiol Calibrators are liquid calibrators to be used with the Access Estradiol assay to generate the estradiol calibration curve on the Access Immunoassay Systems. The Access Estradiol Calibrator kit contains six vials, one for each calibrator level. The Access Immunoassay Systems utilize a competitive binding immunoenzymatic assay for the quantitative measurement of estradiol.

AI/ML Overview

The provided documentation describes a 510(k) premarket notification for a modification to an existing device, the Access® Estradiol Calibrators. The modification is a restandardization of the calibrators' traceability. The document focuses on demonstrating substantial equivalence to the predicate device, not on directly proving new acceptance criteria for a novel device or AI algorithm. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC studies, training set details) are not applicable or not provided in this type of submission.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

The document doesn't explicitly state numerical "acceptance criteria" in the typical sense for an AI/diagnostic algorithm (e.g., sensitivity, specificity thresholds). Instead, the performance demonstrated is that the restandardized calibrators are "substantially equivalent" to the predicate device. This is a regulatory finding rather than a specific performance metric.

Aspect of Performance	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	No change from predicate device	"No Change" in intended use.
Calibrator Levels	New, specified approximate levels (traceable to ID-GC/MS)	Estradiol at approximate levels of 106, 570, 1800, 3100, and 4800 pg/mL, liquid.
Traceability	Traceable to ID-GC/MS reference method (change from predicate)	"Traceable to ID-GC/MS (isotope dilution-gas chromatography/mass spectrometry) reference method."
Fundamental Technology	No alteration from predicate device	"does not... alter the fundamental scientific technology."
Safety and Efficacy	No impact on safety and efficacy compared to predicate device	"does not... affect the safety and efficacy of the device." "Performance data generated from validation testing demonstrates that the restandardized Access Estradiol Calibrators on the Access Immunoassay Systems is substantially equivalent to the currently commercialized Access Estradiol Calibrators."

2. Sample sized used for the test set and the data provenance

The document states "Performance data generated from validation testing," but does not specify the sample size used for this testing or the data provenance. This type of detail is typically found in the full submission, not the 510(k) summary.

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

Not applicable to this type of device (calibrators) or submission. The "ground truth" here refers to the reference method (ID-GC/MS) for estradiol levels, which is a chemical method, not an interpretation by human experts.

4. Adjudication method for the test set

Not applicable. This concept pertains to resolving discrepancies in human interpretation, which is not relevant for the chemical calibration process described.

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 submission is for a medical device (calibrators) that is part of an immunoassay system, not an AI algorithm for image interpretation or diagnosis that would involve human readers.

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

Not applicable. There is no standalone algorithm being evaluated in this submission. The device is a calibrator for an immunoassay system.

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

The "ground truth" for the calibrator values is established through ID-GC/MS (isotope dilution-gas chromatography/mass spectrometry) reference method. This is a highly accurate and precise analytical chemistry method.

8. The sample size for the training set

Not applicable. Calibrators are developed and manufactured according to specific chemical and analytical processes to meet target concentrations. There is no "training set" in the context of machine learning for this type of device.

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

Not applicable. As above, there is no training set. The values for the calibrators are established by rigorous analytical methods (ID-GC/MS) to ensure their accuracy and traceability.

Summary

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MAR 1 9 2008

510(k) SUMMARY

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.

The assigned 510(k) number is: K080166

Submitter's Name and Address

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-7899 Fax: (952) 368-7610 Contact: Jeffrey L. Koll

Date Prepared: March 11, 2008

Device Names

Proprietary Name:	Access® Estradiol Calibrators on the Access®Immunoassay Systems
Common Name:	Calibrators
Classification Name:	Calibrator, Secondary (862.1150. JIT)

Predicate Device

Access Estradiol Calibrators Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

510(k) Number: K973743, K970126

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Device Description

Intended Use

Attribute	Access EstradiolCalibrators	Access EstradiolCalibrators(restandardized)
Intended Use	Calibration for quantitativedetermination of estradiollevels in human serum andplasma	No Change
Calibrators	Estradiol at approximatelevels of 100, 500, 1500,2500, and 3600 pg/mL,liquid	Estradiol at approximatelevels of 106, 570, 1800,3100, and 4800 pg/mL, liquid
Traceability	Traceable to USP referencematerial	Traceable to ID-GC/MS(isotope dilution-gaschromatography/massspectrometry) referencemethod

Summary of Technological Characteristics

The device modification consists of restandardizing the Access Estradiol Calibrators traceability from USP reference material to the ID-GC/MS reference method. There is no change to calibrator materials, functionality, or stability.

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Conclusion

The restandardization of the Access Estradiol Calibrators does not change the intended use or indications for use, alter the fundamental scientific technology, or affect the safety and efficacy of the device. Performance data generated from validation testing demonstrates that the restandardized Access Estradiol Calibrators on the Access Immunoassay Systems is substantially equivalent to the currently commercialized Access Estradiol Calibrators.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 9 2008

Beckman Coulter, Inc. c/o Mr. Jeffrey L. Koll Regulatory Specialist 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

Re: K080166

Trade/Device Name: Access® Estradiol Calibrators on the Access® Immunoassay Systems Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrators Regulatory Class: Class II Product Code: JIT Dated: February 19, 2008 Received: February 20, 2008

Dear Mr. Koll:

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 Statement

510(k) Number (if known):

Device Name: Access® Estradiol Calibrators on the Access® Immunoassay Systems

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson

Sign-Off

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Office of In Vitro Diagnosti bation a

080166

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.