DOCUMENT Thyroid CAL • VER contains assayed solutions intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range on immunochemistry systems and clinical ana volificalled on the following analytes: Thyroxine (T4), Triiodothyronine (T3) and Thyroid Stimulating Hormone (TSH).

Device Description

DOCUMENT Thyroid CAL • VER contains assayed solutions of the following analytes: Thyroxine (T4), Trilodothyronine (T3) and Thyroid Stimulating Hormone (TSH) in a serum matrix. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance of each chemistry. d Thyroid CAL • VER contains 8 levels, 1 bottle per level, 5.0 millliters per bottle.

AI/ML Overview

The provided text describes a medical device called "DOCUMENT Thyroid CAL • VER™", which is a calibration verification quality control material. It contains assayed solutions for measuring Thyroxine (T4), Triiodothyronine (T3), and Thyroid Stimulating Hormone (TSH) in a serum matrix.

However, the document is a 510(k) summary for a calibration verification quality control material. This type of device is used to check the accuracy and linearity of other diagnostic instruments, not for direct diagnosis of patients. Therefore, the concept of "device performance" in terms of clinical accuracy (like sensitivity, specificity, or AUC) as expected for an AI diagnostic device, or a study proving its clinical efficacy, is not applicable here.

The "Performance Characteristics and Data" section in the summary refers to the stability and coverage of the target range for the calibration material itself, not the diagnostic performance of a system using it.

Consequently, much of the requested information (like acceptance criteria for clinical performance, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) is not relevant or present for this specific type of device (calibration verification material).

However, I can extract the relevant performance characteristics mentioned for this device:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Analyte Coverage	Cover reportable range of instrumentation; targets cover clinical reference range	Eight levels provided; targets cover the clinical reference range for T4, T3, and TSH.
Shelf Life	Stable for a specified period	12-month shelf life at frozen temperatures (-10 to -20℃).
Matrix	Serum matrix	Serum matrix
Number of Levels	Multiple levels to establish linearity	8 levels, 1 bottle per level
Volume per Level	Sufficient for use	5.0 milliliters per bottle

Note: The acceptance criteria for a calibration verification material are typically related to its stability, accuracy of target values, and ability to cover the analytical measurement range of the instruments it's intended to verify. The document does not explicitly state numerical acceptance criteria (e.g., ±X% of target value), but rather describes the characteristics of the product. The "reported device performance" are the described characteristics of the product.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This device is a calibration verification material, not a diagnostic test evaluated on patient samples. Its performance is assessed through its manufacturing quality, stability, and calibration against reference methods, not by testing it on a "test set" of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. Ground truth, in the context of an AI diagnostic device, refers to the definitive diagnosis or condition for patient samples. For a calibration verification material, the "ground truth" would be the assayed target values of the analytes within the material, established through rigorous analytical methods and traceability to international standards, not by expert medical opinion on patient cases.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is designed to assess the performance of diagnostic systems (often AI-assisted) by comparing human reader performance with and without AI assistance on a set of patient cases. This is not relevant for a calibration verification material.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

No. This is not an algorithm or an AI device. It's a physical control material.

7. The Type of Ground Truth Used

For a calibration verification material, the "ground truth" refers to the assigned values of the analytes within the material. These values are established through:

Reference measurement procedures: Highly accurate and precise analytical methods, traceable to international standards (e.g., NIST, WHO).
Consensus values: Often determined through inter-laboratory studies using reference methods.

The document does not detail the specific methodology for establishing these assigned values, but it's implicit in a "calibration verification quality control material" that these values are robust and well-defined.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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JUL 23 1999

L992034

ATTACHMENT 3

510(k) SUMMARY

[Refer to 21 CFR §807.92]

CASCO.NERL Diagnostics

Submitted by:	500 Riverside Industrial Parkway
	Portland, ME 04103-1418(207)-878-7550
Contact Person:	Karen Hickey
Date Prepared:	June 10,1999
Proprietary Name:	DOCUMENT Thyroid CAL•VER™
Common Name:	Calibration Verification Quality Control Material
Classification Name:	Control, Multianalyte Assayed(21 CFR §862.1660)
Predicate Device:	DOCUMENT Serum Multianalyte Calibration Verification Test Set510(k) #K950469

Description of the Device:

Intended Use of the Device:

d Thvroid CAL • VER contains assayed solutions for in vitro diagnostic use in the quantitative determination of linearity, calibration verification of reportable range on immunochemistry systems and clinical chemistry systems for the following analytes: Thyroxine (T4), Triodothyronine (T3) and Thyroid Stimulating Hormone (TSH) . This product is not intended for use as a calibration material on instrument systems or as a routine quality control material.

Technological Characteristics:

Many inspection agencies require the documentation of periodic linearity, calibration of reportable range studies on procedures in the clinical laboratory. d Thyroid CAL • VER will assist in this process when used as instructed. In addition, d Thyroid CAL . VER will provide valuable assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.

Performance Characteristics and Data

d Thyroid CAL • VER consists of 8 levels which cover the reportable range of instrumentation on the market. Targets cover the clinical reference range for the analytes present. This product has a 12-month shelf life at frozen temperatures (-10 to -20℃).

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three overlapping human figures, representing the department's focus on people and their well-being. The logo is simple, clean, and easily recognizable.

JUL 2 3 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Karen Hickey Director, Quality Assurance and Regulatory Affairs CASCO NERL Diagnostics Corporation 500 Riverside Industrial Parkway Portland, Maine 04103-1418

K992034 Re: Trade Name: DOCUMENT Thyroid CAL.VERTM Regulatory Class: I Product Code: JJY Dated: June 15, 1999 Received: June 16, 1999

Dear Ms. Hickey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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III. INDICTATIONS FOR USE STATEMENT

510(k) Number (if known): K_99 30,34

Device name: DOCUMENT Thyroid CAL•VER™

Indications for Use:

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter-Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rita E. Madri

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 1992034

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.