The Access Ultrasensitive hGH Calibrators are intended to calibrate the Access Ultrasensitive hGH Assay for the quantitative determination of hGH levels in human serum and plasma on the Access Immunoassay Systems.

Device Description

The Access Ultrasensitive hGH calibrators are lyophilized calibrators to be used with the Access Ultrasensitive hGH assay to generate the hGH calibration curve on the Access Immunoassay Systems. The Access Ultrasensitive hGH calibrator kit contains six 2.0 mL vials, one for each calibrator level. The Access Immunoassay Systems utilize a one-step immunoenzymatic ("sandwich") assay for the quantitative measurement of hGH.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device (calibration kit) and does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML or diagnostic performance as typically measured by metrics like sensitivity, specificity, or accuracy.

The submission focuses on demonstrating substantial equivalence of a modified calibration product to its predicate device. The modification involves restandardizing the calibrators to a new WHO standard. There is no mention of a "device" in the sense of an AI/ML algorithm or a diagnostic instrument that would require establishing ground truth with experts, test sets, or comparative effectiveness studies with human readers.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a diagnostic device. The acceptance criterion is implicit: demonstrate that the restandardized calibrators perform equivalently to the predicate calibrators and do not alter the intended use, indications for use, or fundamental scientific technology, or affect safety and efficacy.
Reported Device Performance: The text states, "Performance data generated from validation testing demonstrates that the restandardized Access Ultrasensitive hGH Calibrators on the Access Immunoassay Systems is substantially equivalent to the currently commercialized Access Ultrasensitive hGH calibrators." However, the specific metrics or values from this "validation testing" are not provided.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
No change in intended use or indications For use	Met
No alteration to fundamental scientific technology	Met
No effect on safety and efficacy	Met
Substantial equivalence to predicate calibrators	Demonstrated through validation testing

2. Sample sized used for the test set and the data provenance: Not applicable. This is a calibration product, not a diagnostic device evaluated with patient samples. The "validation testing" mentioned is likely related to analytical performance (e.g., standard curve generation, precision, accuracy using control materials), not clinical test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for patient diagnosis or imaging interpretation is not relevant for a calibrator product.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is being evaluated.

7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. For the calibrators, the "ground truth" for hGH concentration is traceable to WHO 98/574 (the second international standard).

8. The sample size for the training set: Not applicable. No training set for an AI/ML algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable.

Summary

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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.

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Submitter's Name and Address

JUN - 2 2006

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-7629 Fax: (952) 368-7610 Contact: Jennifer Ruether

Date Prepared: May 5, 2006

Device Names

Proprietary Name:	Ultrasensitive hGH Calibrators on the Access®Immunoassay Systems
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Common Name: Calibrators

Classification Name: Calibrator, Secondary (862.1150, JIT)

Predicate Device

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

510(k) Number: K003089

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Device Description

Intended Use

Attribute	Access Ultrasensitive hGH Calibrators	Access Ultrasensitive hGH Calibrators (modified)
Intended Use	Calibration for quantitative determination of hGH levels in human serum and plasma	Calibration for quantitative determination of hGH levels in human serum and plasma
Calibrators	hGH at approximate levels of 0.1, 1.0, 10, 20, and 50 ng/mL (µg/L), lyophilized	hGH at approximate levels of 0.07, 0.7, 7, 14, or 35 ng/mL (µg/L), lyophilized
Traceability	Traceable to WHO 80/505	Traceable to WHO 98/574

Summary of Technological Characteristics

The device modification consists of restandardizing the Access Ultrasensitive hGH Calibrators from the WHO Pituitary hGH 80/505 standard to the second international standard, WHO 98/574. The restandardization involves the use of the new WHO standard as the reference for assigning the calibrator values; there is no change to calibrator materials, functionality, or stability,

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Conclusion

The restandardization of the Access Ultrasensitive hGH 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 Ultrasensitive hGH Calibrators on the Access Immunoassay Systems is substantially equivalent to the currently commercialized Access Ultrasensitive hGH calibrators.

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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 caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jennifer Ruether Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

JUN - 2 2006

K061282 Re:

Trade/Device Name: Access Ultrasensitive hGH Calibrators on the Access® Immunoassay Systems Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator

Regulatory Class: Class II Product Code: JIT Dated: May 5, 2006 Received: May 8, 2006

Dear Ms. Ruether:

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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutz

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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Indications for Use Statement

510(k) Number (if known): Kd61282

Device Name: Access Ultrasensitive hGH Calibrators on the Access® Immunoassay Systems

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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 Benam
Division Sign-Off

Cice of In Vitro Diagnostic Device Laation and Safery

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K061282

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.