The VALIDATE Lipoprotein Calibration Verification Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity on clinical chemistry for the following analytes: cholesterol, HDL-cholesterol, LDLcholesterol, Apolipoprotein A (Apo-A), and Apolipoprotein B (Apo-B).

The VALIDATE Lipoprotein Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in manual, semi-automated and automated clinical chemistry systems for the following analytes: cholesterol, HDL cholesterol, LDL cholesterol, Apolipoprotein A, and Apolipoprotein B.

Device Description

Quality control material (assayed and unassayed). VALIDATE Lipoprotein Calibration Test Set is a human protein serum based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters. There exists a linear relationship among each set of solutions.

AI/ML Overview

This document is a 510(k) summary for the VALIDATE Lipoprotein Calibration Verification Test Set. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria for performance in a clinical setting.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (like sample size for test/training sets, expert involvement, MRMC studies, or standalone performance) are not directly applicable or available in this type of submission. The device is a quality control material, not a diagnostic algorithm.

Here's a breakdown of the available information based on the prompt:

1. A table of acceptance criteria and the reported device performance:

This document does not present explicit "acceptance criteria" in terms of performance thresholds (e.g., sensitivity, specificity, accuracy) that a diagnostic device would typically have, nor does it present specific performance data beyond stating substantial equivalence. The "performance" described is the intended function of the calibration verification test set, which is to verify calibration, validate reportable ranges, and determine linearity.

The comparison table provided in the submission (Page 1) focuses on characteristics of the device and its predicate:

Characteristic	VALIDATE Lipoprotein Calibration Verification Test Set	VALIDATE Chem 4 Calibration Verification Test Set (Predicate)
Intended Use	For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems.	For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems.
Analytes	CHOL, HDL, LDL, Apo-A, Apo-B	ALP, ALT, AMY, AST, CK, GGT, LD, LIP, TBIL, DBIL
Matrix	human serum	protein
Number of Levels	6 including zero	6 including zero
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	-10 to -20°C	-10 to -20°C

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

Not applicable. This submission describes a quality control material, not a diagnostic device that processes patient data. Therefore, there is no "test set" of patient data in the typical sense for evaluating diagnostic performance. The submission relies on a comparison of device characteristics to a legally marketed 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):

Not applicable. As this is not a diagnostic device involving interpretation of patient data, there were no experts establishing ground truth for a test set.

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

Not applicable.

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 device is not an AI diagnostic tool and does not involve human readers in this context.

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

Not applicable. This device is a physical calibration verification test set, not a software algorithm.

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

Not applicable. The "ground truth" for a calibration verification material would be its precisely manufactured and assigned values for the analytes. The submission implies these values are established through the manufacturing process, but details on how these specific values are determined are not part of this 510(k) summary.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

Summary

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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: K041975."

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

Summary prepared on: July 14, 2004

Device classification name: Multi-Analyte Controls, All Kinds (Assayed and Unassayed) Device description: Quality control material (assayed and unassayed) Proprietary Name: VALIDATE Lipoprotein Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 Product Code: JJY Regulatory Class: Class I

Predicate Device:

1. Chem 4 Calibration Verification Test Set (K012120), manufactured by Maine Standards Company, Windham, ME.
  Device description: VALIDATE Lipoprotein Calibration Test Set is a human protein serum based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters. There exists a linear relationship among each set of solutions.

Intended use: VALIDATE Lipoprotein Calibration Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity on clinical chemistry for the following analytes: cholesterol, HDL-cholesterol, LDLcholesterol, Apolipoprotein A (Apo-A), and Apolipoprotein B (Apo-B).

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Comparison of VALIDATE Lipoprotein Calibration Verification Test Set to the l

eather of the consideration Verification Test Set Companson on Calibration Verification Test Set:

The VALIDATE Lipoprotein Calibration Test Set is substantially equivalent to The VALIDATE Lipoprotein Calibration Test Set (K012120) also manufactured by
the VALIDATE Chem 4 Calibration Verification Test Set (K012120), for its sted use the VALIDATE Chem 4 Gallbration Vermoution 1000 The FDA, for its stated use.

	VALIDATE Lipoprotein CalibrationVerification Test Set	VALIDATE Chem 4 CalibrationVerification Test Set
IntendedUse	For in vitro diagnostic use inquantitatively verifying calibration,validating reportable ranges, anddetermining linearity in automated,semi-automated and manual chemistrysystems.	For in vitro diagnostic use in quantitativelyverifying calibration, validating reportableranges, and determining linearity inautomated, semi-automated and manualchemistry systems.
Analytes	CHOL, HDL, LDL, Apo-A, Apo-B	ALP, ALT, AMY, AST, CK, GGT, LD,LIP, TBIL, DBIL
Matrix	human serum	protein
Number ofLevels	6 including zero	6 including zero
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	-10 to -20°C	-10 to -20°C

Summary:

The information provided in this pre-market notification demonstrates that the performance i he information provided in this pre-market is substantially equivalent in form of VALIDATE Lipoprolem Calibration Verification Test Set (K012120) for its stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 15 2004

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

Re: K041975

Trade/Device Name: VALIDATE® Lipoprotein 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: July 22, 2004 Received: July 22, 2004

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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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 no dicate 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). 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,

Seain M. Cooper, US, DVM.

Jean 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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INDICATIONS FOR USE STATEMENT

510(k) Number: K041975

Device Name: VALIDATE® Lipoprotein Calibration Verification Test Set

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041975

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.