The VALIDATE® Cardiac Marker Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for CK-MB and Myoglobin.

Device Description

VALIDATE Cardiac Markers Calibration Verification Test Sets are human based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of solutions.

AI/ML Overview

The provided text describes a 510(k) summary for the "VALIDATE® Cardiac Markers Calibration Verification Test Set". This device is a quality control material intended to verify calibration, validate reportable ranges, and determine linearity in chemistry systems for CK-MB and Myoglobin. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested elements (acceptance criteria, study design, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of document, which is primarily a regulatory filing for an in vitro diagnostic quality control material.

However, I can provide the available information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not explicitly state numerical acceptance criteria in terms of accuracy, precision, sensitivity, or specificity. Instead, the primary "acceptance criterion" for this regulatory submission is "substantial equivalence" to predicate devices. This means that the device must perform similarly enough to a legally marketed device that it does not raise new questions of safety or effectiveness.

Reported Device Performance:

Characteristic	VALIDATE® CM1 (Preproduction Lots)	Predicate Devices (DOCUMENT® CK-MB CAL•VER and Bio-Rad Liquichek™ Cardiac Markers Control LT)
Performance Claim/Demonstration	The performance of VALIDATE® CM1 Calibration Verification Test Set solutions on the Abbott AxSym instrument system as compared to DOCUMENT® CK-MB CAL•VER and Bio-Rad Liquichek Cardiac Markers Control LT has been shown to be substantially equivalent. This implies that the ranges and linearity observed with the VALIDATE® CM1 material were comparable to those observed with the predicate devices when used in the same context (calibration verification).	DOCUMENT® CK-MB CAL•VER: Intended for quantitative determination of linearity, calibration verification, verification of analytical measurement range (AMR), and clinical reportable range (CRR) of manual and automated chemistry analyzers for CK-MB. Bio-Rad Liquichek™ Cardiac Markers Control LT: Intended as an assayed quality control serum to monitor the precision of laboratory testing procedures for CK-MB, MYO, Digitoxin, Homocysteine, NT-ProBNP, Troponin-I, Troponin-T. The specific performance metrics (e.g., expected linearity, accuracy ranges) of the predicate devices themselves are not explicitly detailed as acceptance criteria within this document, but their established performance serves as the benchmark for "substantial equivalence."

Note: For in vitro diagnostic quality control materials, "performance" is often demonstrated by showing that the material behaves predictably and consistently across a range of values, allowing for the verification of an instrument's calibration and linearity. The specific numerical accuracy or precision of the new material is typically compared to that of existing, similar products rather than to a fixed clinical endpoint.

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

Sample Size for Test Set: The document mentions "preproduction lots of VALIDATE® CM1 Calibration Verification Test Sets". However, it does not specify the number of individual vials, batches, or replicates used in the comparative testing.
Data Provenance: The study appears to be an internal, prospective validation performed by Maine Standards Company. There is no mention of country of origin of the data beyond the company's location in Maine, USA. The study design is not a traditional "test set" in the clinical sense, but rather a laboratory comparison.

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

Not applicable. "Ground truth" in the context of this device refers to the known, assigned values of the analytes in the control material for calibration verification. These values are established through rigorous analytical testing and metrology, not by expert consensus in the way a diagnostic image might be. The document does not specify the number or qualifications of the analytical chemists or metrology experts involved in assigning these values.

4. Adjudication Method for the Test Set

Not applicable. As this is not a diagnostic device involving interpretation, there is no need for adjudication of results by human experts. The "results" are analytical measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is not applicable for this type of in vitro diagnostic quality control material. MRMC studies are typically used to assess the effectiveness of diagnostic devices (e.g., imaging AI) where multiple human readers interpret cases.

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

Not applicable. This device is a physical diagnostic control material, not an algorithm or software. It is designed to be used with human-operated laboratory equipment.

7. The Type of Ground Truth Used

The ground truth for this device is the assigned analyte concentrations within the calibration verification materials. These values are established through a robust process of analytical measurement, often traceable to reference materials and methods, rather than expert consensus, pathology, or outcomes data. The document implies these values are "lot specific analyte values" provided with the product.

8. The Sample Size for the Training Set

Not applicable. This device is a physical in vitro diagnostic control material, not an AI/ML algorithm or system that requires a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the words "JAN 13, 2006" at the top. Below that is the word "maine" above a horizontal line. Below the line is the word "standards" and below that is the word "COMPANY" with each letter separated by a space.

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: K 053247 ."

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

Summary prepared on: November 7, 2005

Device classification name:	Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
Device description:	Quality control material (assayed and unassayed)*
Proprietary Name:	VALIDATE® Cardiac Markers Calibration Verification TestSet
Regulation Number:	21 CFR 862.1660
Product Code:	JJY*

*Note: There is no FDA product code for calibration / linearity materials. Therefore, as with previous submissions by Maine Standards and other calibration verification / linearity manufacturers, JJY has been selected as the "best fit" FDA code for this product.

Regulatory Class: Class I

Predicate Device:

1. Bio-Rad Liquichek Cardiac Markers Control LT (K040277), Bio-Rad Laboratories, Irvine, CA
1. DOCUMENT CK-MB CAL-VER, Microgenics Corporation, Fremont, CA Note: While the package insert for this commercially available product states that it is intended for in vitro diagnostic use in the determination of linearity and calibration verification for CK-MB and the accompanying worksheet provides lot specific analyte values, a k number could not be identified through the CDRH database.

Device description: VALIDATE Cardiac Markers Calibration Verification Test Sets are human based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of solutions.

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Intended use: The VALIDATE Cardiac Markers Calibration Verification Test Sets are 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 analytes listed on the package insert. These materials are not intended for use as routine quality control materials or as calibration materials.

Comparison of VALIDATE® CM 1 Calibration Verification Test Set to the predicate devices:

Table 1 compares characteristics of the VALIDATE® CM1 Calibration Verification Test Set With those of the DOCUMENT CK-MB CAL ●VER and Bio-Rad Liquichek Cardiac Markers Control LT.

	VALIDATE®CM1	DOCUMENT®CK-MB CAL·VER	Bio-RadLiquichek™Cardiac MarkersControl LT
Catalog #	CM1	M-116
IntendedUse	For in vitro diagnostic usein quantitatively verifyingcalibration, validatingreportable ranges, anddetermining linearity inautomated, semi-automated and manualchemistry analyzers.	For use in the quantitativedetermination of linearity,calibration verification,verification of analyticalmeasurement range(AMR), and clinicalreportable range (CRR) ofmanual and automatedchemistry analyzers.	For use as anassayed qualitycontrol serum tomonitor theprecision oflaboratory testingprocedures
Analytes	CK-MB, MYO	CK-MB	CK-MB, MYO,Digitoxin,Homocysteine,NT-ProBNP,Troponin-I,Troponin-T
Matrix	Human Serum	Human Serum	Human Serum
Number ofLevels	6 including zero	6	3
Preparation	Liquid, ready to use	Liquid, ready to use	Liquid, ready to use
Packaging	6 x 3.0mL	6 x 5.0ml	6 x 3.0mL
Stability	Until expiration	Until expiration	10 days afteropening
Storage	-10 to -20°C	-10 to -20°C	-10 to -20°C

TABLE 1 - Comparison of Devices

The performance of VALIDATE® CM1 Calibration Verification Test Set solutions on the Abbott AxSym instrument system as compared to DOCUMENT® CK-MB CAL·VER and Bio-Rad Liquichek Cardiac Markers Control LT has been shown to be substantially equivalent using preproduction lots of VALIDATE® CM1 Calibration Verification Test Sets.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is made up of three thick, curved lines that form the body and wings, and two ribbon-like lines that form the tail.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 3 2006

Ms. Christine Beach Director, QA/RA Maine Standards Co. 765 Roosevelt Trail Suite 9A Windham, ME 04062

Re: K053247

Trade/Device Name: VALIDATE® Cardiac Marker Calibration Verification Test Sets Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: November 10, 2005 Received: November 21, 2005

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, 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 (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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Alberto Guts

Alberto Gutierrez, Ph.D. 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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Indications for Use

K 053247 510(k) Number (if known):

VALIDATE® Cardiac Marker Calibration Verification Test Sets Device Name:

Indications For Use:

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)

R. Chelen for Carol Benson

ision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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K 053277

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.