The Access Free T3 Calibrator set is a device intended for medical purposes for use in the Access Immunoassay Systems to establish points of reference that are used in the determination of values in the measurement of free T3 levels in human serum and plasma.

Device Description

The Access Free T3 Calibrators are designed for use with the Access Free T3 Reagent for generation of the Free T3 assay calibration curve on Beckman Coulter's Access Immunoassay Systems. The Access Free T3 Calibrator kit contains 6 X 2.5 mL bottles, one for each of six calibrator levels. The Access Immunoassay Systems utilize a competitive binding immunoenzymatic method for quantitative analyte measurement.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Access Free T3 Calibrators" and discusses its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or detailed study results that prove the device meets specific performance thresholds.

It states that "Performance data from validation testing supports a finding of substantial equivalence to the Beckman Coulter Access Ultrasensitive hGH Calibrators already in commercial distribution," and mentions "Product claims and specifications." However, these claims and specifications, along with the actual performance data, are not provided in the submitted text.

Therefore, I cannot populate most of the requested fields as the information is not present in the provided document.

Here's an assessment based on the available information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified in the document (Simply states "demonstrated to be equivalent to the predicate product" and "supports a finding of substantial equivalence" based on unspecified "product claims and specifications.")

Study Details

Sample size used for the test set and the data provenance: Not specified in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in the document.
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 a calibrator for an immunoassay system, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an "algorithm only" as a calibrator is a physical product used in conjunction with an immunoassay system. The performance of the calibrators themselves would be evaluated, likely for stability, accuracy in generating a calibration curve, and equivalence to the predicate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified in the document.
The sample size for the training set: Not applicable and not specified. The device is a calibrator, not a machine learning algorithm that requires a "training set" in the conventional sense. Testing would involve validation of its manufacturing and functional performance.
How the ground truth for the training set was established: Not applicable and not specified.

Conclusion: The provided document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria and results. The "Summary of Performance Data" section is very high-level and refers to unspecified "product claims and specifications" and "validation testing." To answer the questions thoroughly, the actual validation reports and performance data submitted to the FDA would be required.

Summary

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DC1 5 - 2004

K042651/

Access Free T3 Calibrator 510(k) Summary

1.0 Submitted By:

Valynda Machen Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 (952) 368-1383 Telephone: (952) 368-7610 FAX:

2.0 Date Submitted

September 27, 2004

3.0 Device Name(s):

Proprietary Names 3.1
Access® Free T3 Calibrators
3.2 Classification Names
Calibrator (21 CFR § 862.1150)

4.0 Legally Marketed Device

The Access Free T3 Calibrators claim substantial equivalence to the Beckman Coulter Access Ultrasensitive hGH Calibrators currently in commercial distribution, FDA 510(k) Number K003098.

5.0 Device Description

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Intended Use 6.0

The Access Free T3 Calibrators are intended to calibrate the Access Free T3 The Access ITEE 15 Oalibrators are internets of free triiodothyronine levels in human assay for the qualifising the Access Immunoassay Systems.

Comparison to the Predicate 7.0

The Access Free T3 Calibrators and the predicate calibrator utilize the same test The Access ITEE 15 Oalbratore and mo productions . Each calibrator is intended for use in a different analyte test system. The Access Free T3 intentied for use in a different are provided in a stabilized bovine serum callurators and the prodicate device contains somatropin (human growth albumin Thum. - The preatedie T3 calibrator contains 3', 3, 5-triiodothyronine. homone) while the Access for are liquid stable while the predicate calibrator is lyophilized and requires preparation.

Summary of Performance Data 8.0

The Access Free T3 Calibrators have been demonstrated to be equivalent to the The Access Product. Based on the results of the performance characteristics predioute product: "Product claims and specifications and specifications.

Performance data from validation testing supports a finding of substantial renomance to the Beckman Coulter Access Ultrasensitive hGH Calibrators already in commercial distribution.

Beckman Coulter, Inc. Access Free T3 Calibrators

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 5 - 2004

Ms. Valynda Machen Senior Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

Re: K042651

K042031
Trade/Device Name: Free T3 Calibrators on the Access Immunoassay System Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: September 27, 2004 Received: September 28, 2004

Dear Ms. Machen:

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 for the enated of 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, do noos mat hat (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 I va may) attols 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 or any I 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) I ms lotter will and wy a the FDA finding of substantial equivalence of your device to a legally premaince notification " assessification 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, ar you store on the promotion and advertising of your device, please contact the Office of or Yatodollo en atte provise Evaluation and Safety at (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, 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): ___ K042651

Device Name: Free T3 Calibrators on the Access Immunoassay Systems

Indications For Use: The Access Free T3 Calibrator set is a device intended for medical purposes for use in the Access Immunoassay Systems to establish points of reference that are used in the determination of values in the measurement of free T3 levels in human serum and plasma.

Prescription Use X (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)

Albert Satz
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042651

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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.