The VALIDATE Chem 6 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analyte: uric acid.

Device Description

VALIDATE Chem 6 Calibration Verification Test Set is an agueous based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analyte. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.

AI/ML Overview

Here's an analysis of the provided text regarding the VALIDATE Chem 6 Calibration Verification Test Set, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by its demonstration of "functional equivalence" and "substantial equivalence" to the predicate device, specifically in terms of linearity and correlation. The study aims to show that the VALIDATE Chem 6 performs as well as the predicate for its intended use.

Acceptance Criteria (Implied)	Reported Device Performance (VALIDATE Chem 6)	Predicate Device Performance (DOCUMENT Uric Acid CAL•VER)
Strong linear correlation (Correlation Coefficient (r)) for Uric Acid	0.99995	0.99996
Regression equation demonstrating similar linearity (Y=intercept + slope(X)) for Uric Acid	Y = 0.031 + 0.956(x)	Y = 0.155 + 0.91(x)
Functional equivalence for calibration verification and linearity assessment to the predicate device	Demonstrated functional equivalence using pre-production lots on a Beckman Synchron CX	Established as a legally marketed device; performance serves as the benchmark for equivalence

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

Sample Size: The document states that the analyte (Uric Acid) was "tested in triplicate." This refers to the number of replicates for each level of the calibration verification test set, not the total number of patient samples. The test set itself consists of six levels (including zero).
Data Provenance: The data was generated using "pre-production lots of VALIDATE Chem 6 Calibration Verification Test Sets." The instrument used was a "Beckman Synchron CX." The data provenance is internal to the manufacturer's testing and development process, likely conducted in the USA (manufacturer is in Maine, USA). It is a prospective study in the sense that it involves testing the new device.

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

This type of device (calibration verification test set) does not involve human expert interpretation of results to establish ground truth in the same way an imaging or diagnostic AI device would. The "ground truth" for linearity and calibration verification is established through the inherent chemical properties and expected concentrations of the analytes within the test solutions, which are then measured by a laboratory instrument. The performance of the predicate device serves as the benchmark for comparison. Therefore, there were no external experts used to establish ground truth in the traditional sense. The expertise lies in the analytical chemistry and metrology of the reference materials and the careful execution of laboratory measurements.

4. Adjudication Method for the Test Set

Not applicable. As explained above, this product does not involve human interpretation or subjective assessment that would require adjudication. The performance is determined by quantitative measurements against known reference values or comparisons to an established predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic devices where human readers (e.g., radiologists, pathologists) interpret images or other data, and the AI device either assists them or performs the interpretation independently. The VALIDATE Chem 6 is a laboratory quality control material, not a diagnostic interpretation device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a sense, a standalone performance was done for the device itself. The device is a "Calibration Verification Test Set," meaning it is a material used by an instrument. The "performance" being evaluated is how the material interacts with the instrument (Beckman Synchron CX) and how the instrument recovers the expected values, demonstrating linearity. The reported correlation coefficients and regression equations are measures of the intrinsic performance of the test set as measured by an instrument. There is no "human-in-the-loop" component to the test set itself, only to the laboratory professional who uses it and interprets the instrument's output.

7. Type of Ground Truth Used

The ground truth is based on:

Reference Values/Expected Concentrations: The "theoretical operation" of linearity and calibration verification is based on the known, manufactured concentrations of uric acid in each level of the VALIDATE Chem 6 set.
Performance of the Predicate Device: The DOCUMENT Uric Acid CAL•VER serves as the established benchmark for "substantial equivalence," meaning its previously validated performance implicitly defines the acceptable range for the new device's ground truth.

8. Sample Size for the Training Set

Not explicitly stated or applicable in the traditional sense of an AI/ML device. This device is a chemical reagent set, not a software algorithm that learns from data. Its "performance" is based on its chemical formulation and interaction with an analyzer. There isn't a "training set" in the context of machine learning.

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

Not applicable, as there is no "training set" for this type of device. The ground truth for the device's performance is established through the analytical chemistry principles by which the calibration verification materials are manufactured and assayed, and then demonstrated by direct comparison to a legally marketed predicate device.

Summary

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NOV 1 6 2001

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: Kol3119

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

Summary prepared on: September 11, 2001

Proprietary Name:	VALIDATE Chem 6 Calibration Verification Test Set
Common Name:	Calibration Verification
Classification Name:	Calibrator, Single Analyte

Predicate Devices:

DOCUMENT Uric Acid CAL-VER, K893139, manufactured by CASCO 1. NERL Diagnostics.
Device description: VALIDATE Chem 6 Calibration Verification Test Set is an agueous based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analyte. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.

Intended use: VALIDATE Chem 6 Calibration Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analyte: uric acid.

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Comparison of VALIDATE Chem 6 Calibration Verification Test Set to the predicate devices:

Table 1 compares characteristics of the VALIDATE Chem 6 Calibration Verification Test Set with those of the DOCUMENT Uric Acid CAL.•VER.

	VALIDATE CHEM 6Calibration Verification TestSet	DOCUMENTUric Acid CAL•VER
Catalog #	10006	M-106
Intended Use	For in vitro diagnostic use inquantitatively verifyingcalibration, validating reportableranges, and determininglinearity in automated, semi-automated and manualchemistry systems.	For in vitro diagnostic use in thequantitative determination oflinearity in manual, automatedand semi-automated chemistrysystems.
Analytes	Uric Acid	Uric Acid
Matrix	aqueous	aqueous
Number ofLevels	6 including Zero	5
Preparation	Liquid,ready to use	Liquid,ready to use
Packaging	5.0 mL each level	5.0 mL each level
Stability	Until Expiration	Until Expiration
Storage	2-8°C	2-8°C

Comparison of Products TABLE 1.

The performance of VALIDATE Chem 6 Calibration Verification Test Set solutions on the Beckman Synchron CX instrument system as compared to DOCUMENT Uric Acid CAL•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 6 Calibration Verification Test Sets. The results of correlation comparisons between the VALIDATE Chem 6 Calibration Verification Test Set and the predicate device are presented in Table 2.

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Linear Regression Statistical Comparison of VALIDATE Chem 5 TABLE 2. Calibration Verification Test Set to the predicate device.

	VALIDATEChem 6Calibration Verification Test Set		DOCUMENTUric AcidCAL·VER
Analyte	CorrelationCoefficient (r)	Regression EquationY=intercept + slope(X)	CorrelationCoefficient(r)	Regression EquationY=intercept + slope(X)
UA	0.99995	$.031 + .956(x)$	0.99996	$.155 + .91(x)$

Summary:

Linear regression analysis was carried out on recovered values for uric acid. The analyte was tested in triplicate. The VALIDATE Chem 6 Calibration Verification andition was been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Uric Acid CAL•VER.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 6 2001

Ms. Christine Beach Manager, RA/QA Maine Standards Company 765 Roosevelt Trail Windham, ME 04062

K013119 Re:

Trade/Device Name: VALIDATE Chem 6 Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 - 862.1660 - 862.1775 Regulation Name: Quality Control Material (assayed and unassayed). Regulatory Class: I Reserved Product Code: JJX Dated: September 11, 2001 Received: September 18, 2001

Dear Ms. Beach:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have love have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 the general of 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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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NOV 1 6 2001

INDICATIONS FOR USE STATEMENT

510(k) Number: Kol3119

Device Name: VALIDATE Chem 6 Calibration Verification Test Set

Indications for Use:

Jean Cooper
(Division Si
Division of (

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

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.