Each VALIDATE® THY Calibration Verification / Linearity Test Set consists of two sets of bottles, a THY Set and a FT4 Set. The THY set consists of five (5) levels of the following four analytes: triiodothyronine (T3), thyroxine (T4), human thyroid stimulating hormone (TSH), and cortisol, and the FT4 set consists of five (5) levels containing Free T4.

VALIDATE® THY Calibration / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in automated, semi automated, and manual chemistry systems.

Device Description

Quality control material (assayed and un-assayed)

VALIDATE®THY Calibration Verification Test Sets are human serum based calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of Levels 1 through 5. One bottle of Base Matrix is also included. There exists a linear relationship among Levels 1 through 5.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the VALIDATE® THY Calibration Verification Test Set:

The provided document is a 510(k) Summary, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets specific performance criteria as a new, de novo device might. Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of demonstrating substantial equivalence.

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

The document does not explicitly present a table of acceptance criteria for the new device as separate from its predicate. Instead, it states that the device is "substantially equivalent in form and function to the predicate device for its stated intended use." This implies that the 'acceptance criteria' for the new device are inherently met if its performance is comparable to the predicate device, which is already legally marketed.

Therefore, we can infer the "acceptance criteria" are the established performance characteristics (e.g., linearity, calibration verification, reportable range verification) demonstrated by the predicate device, and the "reported device performance" is that the new device functions equivalently for these purposes.

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (as stated in the 510(k) Summary)
Demonstrated linearity for T3, T4, TSH, Cortisol, and Free T4.	Substantially equivalent in form and function to the predicate device for its intended use, which includes the quantitative determination of linearity.
Verification of calibration for T3, T4, TSH, Cortisol, and Free T4.	Substantially equivalent in form and function to the predicate device for its intended use, which includes calibration verification.
Verification of reportable range for T3, T4, TSH, Cortisol, and Free T4.	Substantially equivalent in form and function to the predicate device for its intended use, which includes verification of reportable range.
Suitable for use in automated, semi-automated, and manual chemistry systems.	Explicitly stated intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The 510(k) summary does not provide details about a specific test set, its sample size, or data provenance used to demonstrate substantial equivalence. The summary focuses on the intended use and device description, and then makes a general statement about equivalence. In such submissions, detailed performance data is often summarized or referenced rather than fully detailed in the publicly available summary.

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 type of information (number of experts, their qualifications, and their role in establishing ground truth) is not applicable or stated in this 510(k) summary. This device is a quality control material used for analytical performance verification (linearity, calibration, reportable range). The 'ground truth' in this context would likely be established through robust analytical methods, highly precise reference materials, and established metrological traceability, rather than expert review of clinical cases.

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

Not applicable or stated. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple expert readers. This is a quality control material for laboratory instruments, where analytical rigor replaces such human-centric 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 or stated. MRMC studies are used to evaluate diagnostic imaging devices or AI-assisted diagnostic tools where human readers are involved in making clinical decisions. This device is a calibration verification material for in vitro diagnostic assays, not a diagnostic imaging or AI-assisted reading device.

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

Not applicable or stated. This is not an algorithm or AI-based device. It is a physical chemical quality control material.

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

The document does not explicitly state the type of "ground truth" used. However, for a calibration verification and linearity material, the 'ground truth' for the analytes (T3, T4, TSH, Cortisol, Free T4) would typically be established through:

Reference measurement procedures: Highly accurate and precise analytical methods, often traceable to international reference standards.
Certified reference materials: Materials with assigned values derived from definitive methods.
Gravimetric/Volumetric preparation: Precise preparation of the different levels (1-5) to create a known linear relationship across concentrations.

8. The sample size for the training set

Not applicable or stated. As this is a quality control material and not an AI/ML or a complex diagnostic algorithm, there isn't a "training set" in the traditional sense. The device is manufactured to specific specifications and then analytically tested for its characteristics.

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

Not applicable or stated. See point 8. The 'ground truth' for the material itself (i.e., the actual concentration of analytes at each level and their linearity) would be established through the manufacturing process and subsequent analytical characterization using highly precise and accurate laboratory methods.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company LLC. The logo is divided by a diagonal line, with "maine" above the line and "standards" below. The words "COMPANY LLC" are written in smaller letters below "standards".

MAR 2 3 2009

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: (K083891"."

Submitter:	Maine Standards Company
Address:	765 Roosevelt TrailWindham, ME 04062
Telephone:	207-892-1300
Fax:	207-892-2266
Contact:	Holly A. Cressman, Mgr. QA/RA

December 19, 2008 Summary prepared on:

Device classification name:	Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
Device description:	Quality control material (assayed and un-assayed)
Proprietary Name:	VALIDATE® THY Calibration Verification Test Set
Regulation Number:	21 CFR 862.1660
Product Code:	JJY
Regulatory Class:	Class I

Predicate Device:

VALIDATE Calibration Verification Test Set (K062501), Maine Standards Company Windham, Maine

Device description: VALIDATE®THY Calibration Verification Test Sets are human serum based calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of Levels 1 through 5. One bottle of Base Matrix is also included. There exists a linear relationship among Levels 1 through 5.

Intended use; Each VALIDATE® THY-Galibration / Linearity Test Set consists / of two sets of bottles, a THY Set and a ET4 Set your set consists of five (5) levels of the following four analytes: triiodothyronine (T3), thyroxine (T4), human thyroid stimulating hormone (TSH), and cortisol, and the FT4 set consists of five (5) levels containing Free T4.

VALIDATE® TH Calibration Verification / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, and manual chemistry systems.

Summary:

The information provided in this pre-market notification demonstrates that the performance of VALIDATE® THUCalibration Verification Test Sets is substantially equivalent in form and function to the predicate device for its stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 3 2009

Maine Standards Company c/o Ms. Holly A Cressman Manager 765 Roosevelt Trail Windham, ME 04062

Re: K083891 Trade/Device Name: VALIDATE® THY Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: February 17, 2009 Received: February 17, 2009

Dear Ms. Cressman:

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 (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,

Cott C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indications for Use

510(k) Number: K083891

VALIDATE® THY Calibration Verification Test Set Device Name:

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)

Signature of Officer

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K083891

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Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.