The DOCUMENT® Salicylate CAL•VER® solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification, verification of Analytical Measurement Range (AMR) and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate. Multiple levels are provided to establish the linear relationship between theorctical operation and actual performance. There exists a linear relationship among each of the solutions.

Device Description

The DOCUMENT® Salicylate CAL•VER® set consists of 5 levels of solutions containing salicylate - Levels 1 through 5 - with concentrations ranging between 0 to approximately 100 mg salicylate/dL. The base matrix for these solutions is human serum with preservatives added for stability.

AI/ML Overview

The provided text describes a 510(k) summary for the DOCUMENT® Salicylate CAL•VER® kit, which is a quality control material. This type of device does not typically involve the kinds of studies (e.g., clinical trials, AI performance studies, human reader studies) that would have acceptance criteria and performance metrics in the way a diagnostic imaging device or an AI algorithm would.

The submission focuses on demonstrating substantial equivalence to a predicate device (DOCUMENT® Thyroid CAL•VER® kit, K992034) based on intended use and physical properties. There are no performance characteristics for the device itself that would require a study as described in the prompt's requirements (e.g., accuracy, sensitivity, specificity of an algorithm). The device is a calibration verification material, not a diagnostic tool that produces clinical results.

Therefore, many of the requested items are not applicable to this specific device submission. I will address the relevant points based on the provided text, and explicitly state where information is not available or not applicable.

1. Table of acceptance criteria and the reported device performance

For this type of device (calibration verification material), the "performance" is implicitly its ability to fulfill its intended use (linearity, calibration verification) and its physical characteristics matching the predicate. The "acceptance criteria" for regulatory clearance are based on demonstrating substantial equivalence.

Acceptance Criteria Category	Specific Criteria (Implicit for Substantial Equivalence)	Reported Device Performance / Characteristics (from comparison table)
Intended Use	Intended use aligns with predicate device type (in vitro diagnostic for quantitative determination of linearity, calibration verification, etc.).	Subject Device: In vitro diagnostic use in the quantitative determination of linearity, calibration verification, verification of Analytical Measurement Range (AMR), and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate. Multiple levels provided to establish linear relationship. Predicate Device (K992034): Assayed solutions for in vitro diagnostic use in quantitative determination of linearity, calibration verification, and verification of reportable range on immunochemistry and clinical chemistry systems for specific analytes (T4, T3, TSH).
Analytes	Analytes are specified and appropriate for the intended purpose.	Subject Device: Salicylate Predicate Device: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH)
Matrix	Matrix is appropriate and similar to predicate.	Subject Device: Human Serum Predicate Device: Human Serum
Control Form	Physical form is appropriate and similar to predicate.	Subject Device: Liquid Predicate Device: Liquid
Control Levels	Number and range of levels are suitable for linearity and calibration verification.	Subject Device: Five target levels ranging from 0 to approximately 100 mg/dL. Predicate Device: Eight levels across the reportable range.
Storage & Stability	Storage conditions and stability are appropriate for the shelf-life claimed.	Subject Device: 2°C to 8°C until expiration date, noted on vial label. Predicate Device: 2°C to 8°C until expiration date, noted on vial label.
Safety and Effectiveness	The device is safe and effective for its stated intended use, equivalent to a legally marketed predicate. (This is the overarching regulatory acceptance criterion).	"The information supplied in this pre-market notification provides reasonable assurance that DOCUMENT® Salicylate CAL • VER® kit is safe and effective for its stated intended use." (from Section II, Summary)

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

This information is not applicable as there is no "test set" in the context of clinical studies or AI algorithm validation described for this type of device. The submission focuses on demonstrating substantial equivalence through comparison of characteristics to a predicate device.

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 information is not applicable. The device is a quality control material; its intended use does not involve a diagnostic 'test set' that requires expert ground truth establishment.

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

This information is not applicable. See point 3.

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

This information is not applicable. The device is a quality control solution, not an AI-based diagnostic tool, and therefore no MRMC studies or human reader performance analyses were conducted or are relevant.

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

This information is not applicable. The device is not an algorithm or an AI system.

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

This information is not applicable. As a calibration verification material, the "ground truth" relates to the assigned values of the salicylate concentrations within the control solutions, which would typically be established through highly accurate reference methods, not expert consensus on pathology, outcomes, etc. The document does not detail how these salicylate concentrations were assigned or verified, beyond stating they "consist of 5 levels of solutions containing salicylate" and "There exists a linear relationship among each of the solutions."

8. The sample size for the training set

This information is not applicable. The device is not learning-based and does not have a "training set."

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

This information is not applicable. As there is no training set, there is no ground truth establishment for one.

Summary

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Ko41073

SECTION II

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number:

Submitter:

Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: (510)-979-5012 Facsimile: (510) 979-5212

Contact Person:

David Casal, Ph.D. Vice-President, Clinical, Regulatory and Quality Affairs Telephone: (510)-979-5012 Facsimile: (510) 979-5212

Preparation Date:

April21, 2004

Device Information:

Device Classification Name:	Single (Specifi ed) Analyte Control (assayed and unassayed)
Device Description	Quality control material (assayed and unassayed)
Proprietary Name:	DOCUMENT® Salicylate CAL•VER®
Regulation Number:	21 CFR§862.1660
Product Code:	JJX
Regulatory Class:	Class I

Predicate Devices:

Evaluation of the data and results enclosed herein demonstrate that the DOCUMENT® Salicylate CAL • VER® set is substantially equivalent in form and function to the DOCUMENT® Thyroid CAL • VER® set (K992034) for its stated intended use.

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Device Description:

Intended Use:

The DOCUMENT® Salicylate CAL•VER® solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification, verification of Analytical Measurement Range (AMR) and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance. There exists a linear relationship among each of the solutions.

Comparison to Predicate Device(s):

The DOCUMENT® Salicylate CAL•VER® Kit is substantially equivalent to the DOCUMENT® Thyroid CAL• VER® (K992034), also manufactured by Microgenics (CASCO) and previously cleared by FDA, for its stated intended use.

DeviceCharacteristics	Subject Device	Predicate Device (K992034)
Intended Use	The DOCUMENT® SalicylateCAL•VER® solutions are intended forin vitro diagnostic use in thequantitative determination of linearity,calibration verification, verification ofAnalytical Measurement Range (AMR)and verification of the reportable rangeon immunochemistry and clinicalchemistry systems for salicylate.Multiple levels are provided toestablish the linear relationship betweentheoretical operation and actualperformance. There exists a linearrelationship among each of the	· DOCUMENT® Thyroid CAI ·VER® contains assayed solutions forin vitro diagnostic use in thequantitative determination of linearity,calibration verification andverification of reportable range onimmunochemistry systems andclinical chemistry systems for thefollowing analytes: Thyroxine (T4),Triiodothyronine (T3) and ThyroidStimulating Hormone (TSH). Thisproduct is not intended for use as acalibration material on instrumentsystems or as a routine quality control
	solutions.	material.
Analytes(by configuration)	Salicylate	Thyroxine (T4),Triiodothyronine (T3)Thyroid Stimulating Hormone (TSH)
Matrix	Human Serum	Human Serum
Control Form	Liquid	Liquid
Control Levels	Five target levels ranging from 0 toapproximately 100 mg/dL.	Eight levels across the reportablerange
Storage	2°C to 8°C until expiration date	2℃ to 8℃ until expiration date
Stability	Until expiration date noted on viallabel.	Until expiration date noted on viallabel.

Summary:

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The information provided in this pre-market notification demonstrates that the DOCUMENT® Salicylate CAL • VER® kit is substantially equivalent in form and function to the DOCUMENT® Thyroid CAL • VER® (K992034) for its stated intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties of the subject device to the commercially available predicate device. The information supplied in this pre-market notification provides reasonable assurance that DOCUMENT® Salicylate CAL • VER® kit is safe and effective for its stated intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 1 2004

David Casal, Ph.D. Vice President, Clinical, Regulatory and Quality Affairs Microgenics Corp. 46360 Fremont Blvd. Fremont, CA 94538

K041073 Re:

Trade/Devicc Name: DOCUMENT® Salicylate CAL•VER® Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: April 21, 2004 Received: May 10, 2004

Dear Dr. Casal:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreased of 76, the enactment date of the Medical Device Amendments, or to conimores prox to rial and in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, iteres, and on of the Act include requirements for annual registration, listing of general voltaren profice, 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 ean be found in ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rouse be act not 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 edolul statuates and 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 promated 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, n fourstions 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,

Seavin M. Cooper, US, DVM.

Yean 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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SECTION III

INDICATIONS FOR USE STATEMENT

Ko4107 ಿಗೆ 510(k) Number (if known):

DOCUMENT® Salicylate CAL•VER® Kit Device name:

Indications for Use:

Ruth Cheda for Carol Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041073

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)

Page 1 of _

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.