The VALIDATE Chem 2 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 analytes: carbon dioxide, uric acid, glucose, and urea nitrogen.

Device Description

VALIDATE Chem 2 Calibration Verification Test Set contains purified chemicals in an aqueous base. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the VALIDATE Chem 2 Calibration Verification Test Set, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence in this context are not explicitly stated as numerical benchmarks for the device's performance in the typical sense of accuracy, sensitivity, or specificity. Instead, the acceptance criterion for this type of calibrator verification test set is demonstrating functional equivalence and strong correlation to predicate devices. The "reported device performance" is the correlation and regression analysis results achieved during the comparison study.

Analyte	Acceptance Criterion (Implicit)	Reported Device Performance (Correlation Coefficient 'r')	Reported Device Performance (Regression Equation Y=intercept + slope(X))	Predicate Device Used for Comparison
GLU (Glucose)	Strong correlation and comparable linearity to predicate calibrators.	0.99997	1.493 + 0.983X	DOCUMENT Multi-Analyte CAL·VER
BUN (Urea Nitrogen)	Strong correlation and comparable linearity to predicate calibrators.	0.99984	0.95 + 0.965X	DOCUMENT Multi-Analyte CAL·VER
CO2 (Carbon Dioxide)	Strong correlation and comparable linearity to predicate calibrators.	0.99888	0.514 + 0.946X	DOCUMENT Direct ISE CAL·VER
UA (Uric Acid)	Strong correlation and comparable linearity to predicate calibrators.	0.99935	-0.192 + 1.009X	DOCUMENT Uric Acid CAL·VER

Note on Acceptance Criteria: For calibrators and verification materials, the primary method to demonstrate safety and effectiveness for a 510(k) submission is typically by showing substantial equivalence to a legally marketed predicate device. This involves demonstrating that the new device performs similarly in its intended use, often through linearity and correlation studies. A correlation coefficient close to 1 (e.g., >0.99) and a regression slope close to 1 with an intercept close to 0 typically indicate strong agreement and functional equivalence.

2. Sample Sizes and Data Provenance

Test Set Sample Size: "Each analyte was tested in triplicate." This implies that for each analyte within the VALIDATE Chem 2 set (Glucose, BUN, CO2, UA), three measurements were taken. Since the set contains 6 levels, this would mean 6 levels * 3 replicates = 18 data points per analyte for the VALIDATE Chem 2 set. The predicate devices also have multiple levels (5 levels typically), which would also be tested similarly.
Data Provenance: Not explicitly stated, but typically such studies for regulatory submissions are conducted in a controlled laboratory setting (e.g., at the manufacturer's facility or a contract lab). The use of a "Roche Diagnostics Hitachi 911 instrument system" is mentioned. The data is retrospective in the sense that it's generated from pre-production lots for the purpose of demonstrating equivalence, not collected from ongoing clinical use. The country of origin is implicitly the United States, given the submitter is a US company and the submission is to the FDA.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a calibration verification test set, not a diagnostic device that requires expert interpretation of results. The "ground truth" for calibrators relates to their assigned values and their performance in establishing linearity, which is determined by analytical methods, not human experts.

4. Adjudication Method

Not applicable for this type of device and study. Adjudication is relevant for studies involving human interpretation or subjective assessments.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices or other tools where human readers interpret results, and the AI's role is to assist or replace human interpretation. The VALIDATE Chem 2 device is a laboratory reagent for instrument calibration.

6. Standalone (Algorithm Only) Performance

Not applicable. The device itself is a physical reagent (test set) used by laboratory instruments. There is no "algorithm only" performance to evaluate. The performance noted ("Correlation Coefficient (r)" and "Regression Equation") reflects how well the combined system (instrument + VALIDATE Chem 2) performs compared to the combined system (instrument + predicate device).

7. Type of Ground Truth Used

The ground truth used here is the assigned values/concentrations of the calibrator materials (both the VALIDATE Chem 2 and the predicate devices) and their pre-established linearity in verifying instrument performance. The study aims to show that the new device measures these known values in a way that correlates strongly with how predicate devices measure them, thereby establishing its own suitability for linearity determination.

8. Sample Size for the Training Set

Not applicable. This device is a chemical reagent and not an AI/ML algorithm that requires a separate training set. The study describes the performance of the final product (pre-production lots).

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

Not applicable, as there is no training set in the context of an AI/ML model for this device. The "ground truth" for calibrator values is established through rigorous analytical chemistry methods for assaying the concentrations of the constituents in the calibrator solution.

Summary

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AUG 2 0 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: KOIQII I B

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

Summary prepared on: July 2, 2001

Proprietary Name:	VALIDATE Chem 2 Calibration Verification Test Set
Common Name:	Calibration Verification
Classification Name:	Calibrator, Multi-Analyte

Predicate Devices:

1. DOCUMENT Multi-Analyte CAL-VER, K870252, manufactured by CASCO NERL Diagnostics.
DOCUMENT Uric Acid CAL-VER, K893139, manufactured by CASCO 2. NERL Diagnostics.
ന് DOCUMENT Direct ISE CAL-VER, K881773, manufactured by CASCO NERL Diagnostics.

Device description: VALIDATE Chem 2 Calibration Verification Test Set contains purified chemicals in an aqueous base. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.

Intended use: VALIDATE Chem 2 Calibration Verification 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 analytes: carbon dioxide, uric acid, glucose and urea nitrogen.

Office location . 765 Roosevelt Trail . Windham, Maine 04062 Mailing address • P.O. Box 8360 • Portland, ME 04104-8360 Tel. 207-892-1300 · Fax 207-892-2266 · Toll Free 800-377-9684

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Comparison of VALIDATE Chem 2 Calibration Verification Test Set to the predicate devices:

Table 1 compares characteristics of the VALIDATE Chem 2 Calibration Verrification Test Set with those of the DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER, and DOCUMENT Uric Acid CAL•VER.

	VALIDATECHEM 2CalibrationVerification TestSet	DOCUMENTMulti-AnalyteCAL·VER	DOCUMENTDirect ISECAL·VER	DOCUMENTUric AcidCAL·VER
Catalog #	10002	M-100	M-101	M-106
Intended Use	For in vitrodiagnostic use inquantitativelyverifyingcalibration,validatingreportableranges, anddetermininglinearity inautomated, semi-automated andmanual chemistrysystems.	For in vitrodiagnostic use inthe quantitativedetermination oflinearity inmanual,automated andsemi-automatedchemistrysystems.	For in vitrodiagnostic use inthe quantitativedetermination oflinearity inmanual,automated andsemi-automatedchemistrysystems.	For in vitrodiagnostic use inthe quantitativedetermination oflinearity inmanual,automated andsemi-automatedchemistrysystems.
Analytes	GLU, BUN, CO2UA	GLU, BUN, NA,K, CL, CRE, CA,PO4	CO2	UA
Matrix	aqueous	aqueous	aqueous	aqueous
Number ofLevels	6 including Zero	5	5	5
Preparation	Liquid,ready to use	Liquid,ready to use	Liquid,ready to use	Liquid,ready to use
Packaging	5.0 mL each level	15.0 mL eachlevel	10.0 mL eachlevel	5.0 mL each level
Stability	Until Expiration	Until Expiration	Until Expiration	Until Expiration
Storane	2-800	18-2590	18-2590	2-8°C

TABLE 1.	Comparison of VALIDATE Chem 2 Calibration Verification Test Set to
	the predicates devices.

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The performance of VALIDATE Chem 2 Calibration Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER, and DOCUMENT Uric Acid CAL•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 2 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 2 Calibration Verification Test Set and the predicate devices are presented in Table 2.

	VALIDATEChem 2CalibrationVerification Test Set		DOCUMENTMulti-AnalyteCAL·VER		DOCUMENTDirect ISECAL·VER		DOCUMENTUric AcidCAL·VER
Analyte	CorrelationCoefficient(r)	RegressionEquationY=intercept+ slope(X)	CorrelationCoefficient(r)	RegressionEquationY=intercept+ slope(X)	CorrelationCoefficient(r)	RegressionEquationY=intercept+ slope(X)	CorrelationCoefficient(r)	RegressionEquationY=intercept+ slope(X)
GLU	0.99997	1.493 +.983	0.99994	2.529 +1.02	N/A	N/A	N/A	N/A
BUN	0.99984	.95 + .965	0.99972	1.836 +.924	N/A	N/A	N/A	N/A
CO2	0.99888	.514 +.946	N/A	N/A	.99791	3.58 +.875	N/A	N/A
UA	0.99935	-.192 +1.009	N/A	N/A	N/A	N/A	0.99990	.147 +.959

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

Summary:

Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE Chem 2 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Multi-Analyte CAL.VER, DOCUMENT Direct ISE CAL.VER, and DOCUMENT Uric Acid CAL.VER.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with a curved line beneath them.

AUG 2 0 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: 510(k) Number: K012118 Trade/Device Name: VALIDATE Chem 2 Calibration Verification Test Set Regulation Number: 862.1660 Regulatory Class: Class I, Reserved Product Code: JJY Dated: July 3, 2001 Received: July 6, 2001

Dear Ms. Beach:

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 to 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 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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Page 2 -

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" (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 Gutman

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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INDICATIONS FOR USE STATEMENT

510(k) Number: _KOI2118

Device Name: VALIDATE Chem 2 Calibration Verification Test Set

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

X OR Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Kesia Alexander for Sean Casper
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K012118

2 - 1

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.