ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545

K080166 · Beckman Coulter, Inc. · JIT · Mar 19, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080166
• Device Name: ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
• Applicant: Beckman Coulter, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Mar 19, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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 Story

Device is a re-standardized estradiol calibrator for Beckman Coulter Access immunoassay systems. Modification involves shifting calibration traceability from USP reference material to isotope dilution gas chromatography/mass spectroscopy (ID-GC/MS) method. Used in clinical laboratory settings by laboratory technicians to calibrate estradiol assays. Output provides standardized reference values for patient sample quantification, ensuring consistency in estradiol measurement. Benefits include improved accuracy and traceability of clinical test results.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm performance following re-standardization of the calibrator.

Technological Characteristics

Liquid calibrators containing estradiol at levels of approximately 106, 570, 1800, 3100, and 4800 pg/mL. Traceability is established via ID-GC/MS (isotope dilution-gas chromatography/mass spectrometry) reference method. The device is used with the Access Immunoassay Systems, which utilize a competitive binding immunoenzymatic assay.

Indications for Use

Indicated for the calibration of the Access Estradiol assay for quantitative determination of estradiol levels in human serum and plasma using Access Immunoassay Systems.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Beckman Coulter Access Estradiol Calibrator (K097343)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Contact: Jeffrey L. Koll

Date Prepared: March 11, 2008

#### Device Names

| Proprietary Name: | Access® Estradiol Calibrators on the Access®<br>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

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.

## Intended Use

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.

| Attribute | Access Estradiol<br>Calibrators | Access Estradiol<br>Calibrators<br>(restandardized) |
|--------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | Calibration for quantitative<br>determination of estradiol<br>levels in human serum and<br>plasma | No Change |
| Calibrators | Estradiol at approximate<br>levels of 100, 500, 1500,<br>2500, and 3600 pg/mL,<br>liquid | Estradiol at approximate<br>levels of 106, 570, 1800,<br>3100, and 4800 pg/mL, liquid |
| Traceability | Traceable to USP reference<br>material | Traceable to ID-GC/MS<br>(isotope dilution-gas<br>chromatography/mass<br>spectrometry) reference<br>method |

## 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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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 [phone]. 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 [phone] or [phone] 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:

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.

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

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