The VALIDATE Chem 9 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity for automated and manual chemistry systems for the following eighteen analytes: albumin (ALB), calcium (CA), cholesterol (CHOL), chloride (CL), carbon dioxide (CO2), creatinine (CRE), glucose (GLU), iron (FE), lactate (LAC), lithium (LI), magnesium (MG), phosphorus (PQ4), potassium (K), sodium (NA), total protein (TP), triglyceride (TRIG), urea nitrogen (BUN), and uric acid (UA).

The VALIDATE Chem 9 Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated, and manual clinical chemistry systems for the following eighteen analytes. albumin, calcium, cholesterol, chloride, carbon dioxide, creatinine, glucose, iron, lactate, lithium, magnesium, phosphorus, potassium, sodium, total protein, triglyceride, urea nitrogen, and uric acid.

Device Description

VALIDATE Chem 9 Calibration Verification Test Set contains purified chemicals in a protein matrix. 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 five (5) levels. Each bottle contains 5 milliliters.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VALIDATE Chem 9 Calibration Verification Test Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VALIDATE Chem 9 device are not explicitly stated as numerical thresholds (e.g., "correlation coefficient must be > 0.99"). Instead, the primary acceptance criterion is "functional equivalence for calibration verification and linearity assessment" to the predicate devices. This functional equivalence is demonstrated through linear regression analysis and correlation coefficients.

The reported device performance, represented by the correlation coefficients (r) and regression equations, establishes this equivalence.

Analyte	Acceptance Criteria (Implied)	VALIDATE Chem 9 Performance (Correlation Coefficient (r))	VALIDATE Chem 9 Regression Equation (Y = slope(X) + intercept)	Predicate 1 (DOCUMENT Serum) Performance (Correlation Coefficient (r))	Predicate 1 (DOCUMENT Serum) Regression Equation (Y = slope(X) + intercept)	Predicate 2 (Ortho-Clinical VITROS) Performance (Correlation Coefficient (r))	Predicate 2 (Ortho-Clinical VITROS) Regression Equation (Y = slope(X) + intercept)
ALB	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9942	x - 0.1	0.998	0.997x + 0.022	(Not applicable for this analyte)	(Not applicable for this analyte)
BUN	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9999	1.0138x - 0.4276	0.999	1.005x + 0.618	(Not applicable for this analyte)	(Not applicable for this analyte)
CA	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9974	1.01x + 0.288	0.999	0.995x + 0.035	(Not applicable for this analyte)	(Not applicable for this analyte)
CHOL	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9999	0.9935x + 1.8102	0.995	1.058x - 6.192	(Not applicable for this analyte)	(Not applicable for this analyte)
CL	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9996	0.9581x + 3.6226	0.998	1.010x - 1.389	(Not applicable for this analyte)	(Not applicable for this analyte)
CO2	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9971	0.875x + 1.675	0.998	1.009x - 0.176	(Not applicable for this analyte)	(Not applicable for this analyte)
CRE	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9986	0.9364 + 0.1791	0.999	0.974x + 0.073	(Not applicable for this analyte)	(Not applicable for this analyte)
FE	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9988	0.9205x + 14.617	0.998	1.119x - 14.492	(Not applicable for this analyte)	(Not applicable for this analyte)
GLU	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9999	1.0132x - 0.7707	0.999	1.050x - 9.370	(Not applicable for this analyte)	(Not applicable for this analyte)
K	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9987	0.9984x - 0.2576	0.999	0.983 + 0.170	(Not applicable for this analyte)	(Not applicable for this analyte)
LITH	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9997	0.9733x + 0.0187	0.994	0.924x + 0.015	(Not applicable for this analyte)	(Not applicable for this analyte)
MG	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9993	0.9832 + 0.1053	0.998	1.051x - 0.082	(Not applicable for this analyte)	(Not applicable for this analyte)
NA	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9991	1.0042x + 1.8979	0.998	1.076x - 7.561	(Not applicable for this analyte)	(Not applicable for this analyte)
PO4	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9998	0.975x + 0.035	0.999	0.992x + 0.093	(Not applicable for this analyte)	(Not applicable for this analyte)
TP	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9986	1.097x - 0.5097	0.998	1.086x - 0.261	(Not applicable for this analyte)	(Not applicable for this analyte)
TRIG	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9999	1.0226x - 3.6259	0.999	1.018x + 2.292	(Not applicable for this analyte)	(Not applicable for this analyte)
URIC ACID	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	0.9997	0.97x + 0.161	0.999	0.992x + 0.040	(Not applicable for this analyte)	(Not applicable for this analyte)
LAC	Functional equivalence to predicate devices (demonstrated by high correlation and similar regression).	1.0000	1.012x - 0.0272	(Not applicable for this analyte)	(Not applicable for this analyte)	0.9995	0.9398x + 0.0692

Note: For the LAC analyte, the comparison is specifically against Ortho-Clinical Diagnostics VITROS Calibrator Kit 1, which primarily targets lactate.

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

Sample Size: The document states that performance was evaluated on "pre-production lots of VALIDATE Chem 9 Calibration Verification Test Set." It also mentions, "Each analyte was tested in triplicate." However, the specific number of distinct samples or cases in the test set is not explicitly stated. The core of the test involves comparing values obtained from the VALIDATE Chem 9 kit to those from predicate devices across multiple concentration levels (5 levels for VALIDATE Chem 9 and DOCUMENT Serum, 3 levels for Ortho-Clinical VITROS).
Data Provenance: The document does not specify the country of origin of the data. The study appears to be prospective in nature, as it uses "pre-production lots" of the VALIDATE Chem 9 device for comparison.

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

This type of study does not involve "experts" in the human diagnostic sense (e.g., radiologists). Instead, the "ground truth" or reference values are established by the well-characterized and legally marketed predicate devices (DOCUMENT Serum Multi-Analyte CAL·VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1). The performance of these predicate devices on the VITROS instrument system serves as the benchmark against which the new device is compared.

4. Adjudication Method for the Test Set

Not applicable. This study involves a direct measurement comparison between calibration verification materials on an instrument system, not human interpretation requiring adjudication.

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

Not applicable. This is a study comparing in vitro diagnostic calibration materials, not a human-in-the-loop diagnostic imaging study involving human readers or AI.

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

This study is inherently a "standalone" performance evaluation of the calibration verification test set, as it assesses its behavior on an instrument system (specifically the VITROS instrument system). There is no human intervention in the performance of the calibration verification process itself, beyond the initial setup by laboratory professionals. The comparison is between the new device and existing devices, all performing their function as "algorithms" (or chemical/physical standards) on the instrument.

7. The Type of Ground Truth Used

The "ground truth" is established by the performance of the legally marketed predicate devices (DOCUMENT Serum Multi-Analyte CAL·VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1) on the VITROS instrument system. This can be considered a form of reference standard comparison against established and accepted laboratory calibration materials.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical calibration verification test set, not an AI/ML algorithm that requires a training set. Its "performance" is inherent to its chemical composition and how it interacts with analytical instruments.

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

Not applicable, as this is not an AI/ML device requiring a training set.

Summary

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1023352

NOV 22 2002

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: _

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

Summary prepared on: September 30, 2002

Proprietary Name:	VALIDATE Chem 9 Calibration Verification Test Set
Common Name:	Calibration Verification
Classification Name:	Calibrator, Multi-Analyte

Predicate Devices:

1. DOCUMENT Serum Multi-Analyte CAL-VER, K950469, manufactured by CASCO NERL Diagnostics.
1. Ortho-Clinical Diagnostics VITROS Calibrator Kit 1

Device description: VALIDATE Chem 9 Calibration Verification Test Set contains purified chemicals in a protein matrix. 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 five (5) levels. Each bottle contains 5 milliliters.

Intended use: VALIDATE Chem 9 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity for automated and manual chemistry systems for the following eighteen analytes: albumin (ALB), calcium (CA), cholesterol (CHOL), chloride (CL), carbon dioxide (CO2), creatinine (CRE), glucose (GLU), iron (FE), lactate (LAC), lithium (LI), magnesium (MG), phosphorus (PQ4), potassium (K), sodium (NA), total protein (TP), triglyceride (TRIG), urea nitrogen (BUN), and uric acid (UA).

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Comparison of VALIDATE Chem 9 Calibration Verification Test Set to the predicate devices:

Table 1 compares characteristics of the VALIDATE Chem 9 Calibration Verification Test Set with those of the DOCUMENT Serum Multi-Analyte CAL.•VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1.

	VALIDATE CHEM 9CalibrationVerification Test Set	DOCUMENT SerumMulti-AnalyteCAL·VER	Ortho-ClinicalDiagnostics VITROSCalibrator Kit 1
Catalog #	109	M-115	1882208
Intended Use	For in vitro diagnosticuse in quantitativelyverifying calibration,validating reportableranges, anddetermining linearity inautomated, semi-automated and manualchemistry systems	For in vitro diagnosticuse in the quantitativedetermination oflinearity in manual,automated and semi-automated chemistrysystems.	For use in thecalibration of VITROSchemistry systems forthe quantitativemeasurementof lactate.
Analytes	ALB, CA, CHOL, CL,CO2, CREAT, GLU, FE,LAC, LITH, MG, PO4,K, NA, TPROT, TRIG,BUN, URIC ACID	ALB, CA, CHOL, CL,CO2, CREAT, GLU, FE,LITH, MG, PO4, K, NA,TPROT, TRIG, BUN,URIC ACID	LAC
Matrix	Bovine serum albumin	Human serum	Bovine serum albumin
Number ofLevels	5	5	3
Preparation	Liquid,ready to use	Liquid,ready to use	Lypholized
Packaging	5.0 mL each level	2 x 3.0 mL each level	3.0 mL each level
Stability	9 months	9 months	24 hours afterreconstitution
Storage	-10 to -20°C	-10 to -20°C	-10 to -20°C

Comparison of Products TABLE 1.

The performance of VALIDATE Chem 9 Calibration Verification Test Set solutions on the VITROS instrument system as compared to DOCUMENT Serum Multi-Analyte CAL.•VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1 been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 9 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 9 Calibration Verification Test Set and the predicate devices are presented in Table 2.

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		VALIDATE	DOCUMENT
	Chem 9 Calibration Verification Test Set		Serum Multi-Analyte CAL•VER
Analyte	Correlation Coefficient(r)	Regression EquationY = slope(X) + intercept	Correlation Coefficient(r)	Regression EquationY = slope(X) + intercept
ALB	0.9942	x - 0.1	0.998	0.997x + 0.022
BUN	0.9999	1.0138x - 0.4276	0.999	1.005x + 0.618
CA	0.9974	1.01x + 0.288	0.999	0.995x + 0.035
CHOL	0.9999	0.9935x + 1.8102	0.995	1.058x - 6.192
CL	0.9996	0.9581x + 3.6226	0.998	1.010x - 1.389
CO2	0.9971	0.875x + 1.675	0.998	1.009x - 0.176
CRE	0.9986	0.9364 + 0.1791	0.999	0.974x + 0.073
FE	0.9988	0.9205x + 14.617	0.998	1.119x - 14.492
GLU	0.9999	1.0132x - 0.7707	0.999	1.050x - 9.370
K	0.9987	0.9984x - 0.2576	0.999	0.983 + 0.170
LITH	0.9997	0.9733x + 0.0187	0.994	0.924x + 0.015
MG	0.9993	0.9832 + 0.1053	0.998	1.051x - 0.082
NA	0.9991	1.0042x + 1.8979	0.998	1.076x - 7.561
PO4	0.9998	0.975x + 0.035	0.999	0.992x + 0.093
TP	0.9986	1.097x - 0.5097	0.998	1.086x - 0.261
TRIG	0.9999	1.0226x - 3.6259	0.999	1.018x + 2.292
URICACID	0.9997	0.97x + 0.161	0.999	0.992x + 0.040

		TABLE 2. Linear Regression Statistical Comparison of VALIDATE Chem 9
		Calibration Verification Test Set to the predicate devices.

VALIDATEChem 9Calibration Verification Test Set			Ortho-Clinical Diagnostics VITROSCalibrator Kit 1
Analyte	Correlation Coefficient(r)	Regression EquationY = slope(X) + intercept	Correlation Coefficient(r)	Regression EquationY = slope(X) + intercept
LAC	1.0000	1.012x - 0.0272	0.9995	0.9398x + 0.0692

Summary:

Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE Chem 9 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Serum Multi-Analyte CAL.�VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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od and Drug Administra 98 Gaither Road ckville MD 20850

OV 22 2002

Ms. Christine Beach Manager, RA/QA Maine Standards Company 765 Roosevelt Trail - Suite 9A Windham, ME .04062

Re: K023352

Trade/Device Name: Validate Chem 9 Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 30, 2002 Received: October 7, 2002

Dear Ms. Beach:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (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 may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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 comply with all the Act s requirements. 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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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 marketed 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, or questions 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). 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: ________________

Device Name: Validate Chem 9 Calibration Verification Test Set

Indications for Use:

Gran Crogn

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023352

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.