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 chemistry systems for the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol.

Device Description

DOCUMENT® Thyroid CAL . VER contains assayed solutions of the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol in a serum matrix. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance of each chemistry. DOCUMENT Thyroid CAL . VER contains 6 levels, 1 bottle per level, 5.0 milliliters per bottle.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the DOCUMENT® Thyroid CAL•VER™ device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Covers the reportable range of instrumentation on the market for Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol analytes.	DOCUMENT® 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.	Targets cover the clinical reference range for the analytes present.
Shelf life at frozen temperatures (-10 to -20℃).	This product has a 12-month shelf life at frozen temperatures (-10 to -20℃).

Study Details

It's important to note that the provided document is a 510(k) summary for a premarket notification. These summaries generally focus on establishing substantial equivalence to a predicate device rather than detailing comprehensive clinical efficacy studies for the device itself. Therefore, many of the requested details about a study proving the device meets acceptance criteria are not explicitly present in this type of document.

The document primarily states the device's characteristics and its intended use for calibration verification and linearity studies. The "Performance Characteristics and Data" section merely describes the device's attributes, not the results of a formal study to prove those attributes met a predefined acceptance criteria with a specific sample size, ground truth, or expert involvement.

Based on the provided text, here's what can be inferred or explicitly stated:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated. The document mentions the device has "8 levels" and "targets cover the clinical reference range," but it doesn't describe a specific "test set" in the context of a validation study with a defined sample size. The provenance of any underlying data is also not mentioned.
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):
- Not applicable/Not explicitly stated. This device is a calibration verification material. Its "ground truth" (i.e., the theoretical values for each analyte at each level) would be established during its manufacturing process and quality control, not by expert consensus in the way a diagnostic imaging device's ground truth would be. The document does not describe the process of establishing these theoretical values or the experts involved.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not explicitly stated. Adjudication methods are typically used in clinical studies involving interpretation of results, which is not the primary function of this calibration material.
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:
- No. This device is a calibration verification material, not an AI-powered diagnostic tool. MRMC studies are not relevant to its function.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical reagent, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For a calibration verification material, the "ground truth" would be the assigned, theoretical concentration values for each analyte at each of the 8 levels. This is established through rigorous gravimetric and/or volumetric preparation, followed by extensive analytical testing using reference methods and/or highly characterized reference materials within the manufacturer's quality control process. The document does not specify how these theoretical values were assigned.
The sample size for the training set:
- Not applicable/Not explicitly stated. This device is a material for verifying the performance of other instruments, not a learning algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this type of device.

Summary

{0}------------------------------------------------

NOV 26 1999

ATTACHMENT 2

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:	September 7, 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® Thyroid CAL•VER™510(k) #K992034

Description of the Device:

Intended Use of the Device:

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

Technological Characteristics:

Many inspection agencies require the documentation of periodic linearity, calibration verification of reportable range studies on procedures in the clinical laboratory, DOCUMENI® 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

DOCUMENT® 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℃).

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized depiction of a human figure embracing a bird, representing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 26 1999

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

Re: K993014

Trade Name: DOCUMENT Thyroid CAL VERTM Regulatory Class: I Product Code: JJY Dated: September 3, 1999 Received: September 8, 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.

{2}------------------------------------------------

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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Autman

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

{3}------------------------------------------------

III. INDICTATIONS FOR USE STATEMENT

510(k) Number (if known): K_993014

Device name: DOCUMENT Thyroid CAL•VER™

Indications for Use:

Prescription Use (Per 21 CFR 801.109) OR

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)

Teta E. Mahini

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K993014

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.