Validate® GC Calibration Verification / Linearity Test Sets are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi automated, and manual chemistry systems. See attached Package Insert labeling for all analytes claimed.

Device Description

VALIDATE® GC Calibration Verification / Linearity Test Sets are human and aqueous 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 is a 510(k) summary for a medical device called "VALIDATE® GC Calibration Verification / Linearity Test Sets." This device is a quality control material intended for in vitro diagnostic use to determine linearity, calibration verification, and reportable range in chemistry systems.

It is crucial to understand that this submission is for a quality control material, not an AI device or an imaging device. Therefore, the concepts of human readers, AI assistance, complex imaging, and expert adjudication (as typically applied in imaging or AI-driven diagnostic tools) are not applicable here. The "device" in this context is a set of chemical solutions with known properties, and its performance is evaluated based on its chemical stability, consistency, and how accurately it can verify the calibration and linearity of laboratory instruments.

Given this context, I will address the questions as they pertain to a quality control material and the information provided in the 510(k) summary. Many of the questions are specifically designed for AI/imaging devices and cannot be directly answered from the provided text for a chemical control.

Here's the analysis:

Acceptance Criteria and Study for VALIDATE® GC Calibration Verification / Linearity Test Sets

The core of the study for this type of device lies in demonstrating its equivalence to existing predicate devices and its ability to accurately assess the linearity and calibration of various chemistry analyzers.

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

The provided 510(k) summary does not include a detailed table of specific acceptance criteria or reported device performance data. It states:

"The VALIDATE® GC Calibration Verification / Linearity Test Sets behave in a manner suitable for the evaluation of calibration, verification of reportable range, and the linear response of the listed analytes over the ranges tested when compared to the predicate devices."
"VALIDATE® GC Calibration Verification / Linearity Test Sets are as safe, as effective, and perform as well as or better than the predicate device."

Such specific data would typically be found in the full 510(k) submission, including the package insert and detailed study reports, which are not part of this summary excerpt. For a calibration verification material, acceptance criteria would typically include:
* Linearity: The observed values for each level across the concentration range should demonstrate a linear relationship. This is often assessed by linear regression analysis, with criteria for correlation coefficient (e.g., R > 0.99) and acceptable deviation from linearity (e.g., % bias at specific points).
* Accuracy/Bias: The expected values of the control material should be accurately recovered by the chemistry systems, often compared to target values with a specified allowable bias.
* Stability: The material must maintain its stated characteristics over its shelf life and during use.
* Matrix Effects: Minimal interference from the control material matrix on various analytical methods.

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

The summary does not specify the sample size (e.g., number of runs, number of instruments, number of analyte levels tested on each instrument) or the provenance (country, retrospective/prospective) of the data. For this type of device, a "test set" would refer to the various levels of the calibration verification material across different analytes, tested on multiple instrument platforms.

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)

This question is not applicable to a chemical quality control material. "Ground truth" for these materials is established through rigorous manufacturing processes, formulation, and analytical testing by qualified chemists and laboratory personnel using highly accurate reference methods and/or validated assays. It's not typically established by clinical "experts" in the sense of physicians or radiologists.

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

This question is not applicable to a chemical quality control material. Adjudication methods like 2+1 are used for human interpretation of clinical data (e.g., image reading) where disagreement among experts might occur. The "truth" for a chemical control is determined by its inherent chemical properties and the accuracy of its manufacture and assay.

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

This question is completely inapplicable. MRMC studies and "human readers improving with AI" are concepts specific to AI-assisted diagnostic imaging or similar interpretation tasks. This device is a chemical control, not an AI or imaging diagnostic tool.

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

This question is completely inapplicable. There is no "algorithm" in the sense of AI or software for this chemical control material. The device itself is a physical substance.

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

As mentioned in #3, "ground truth" for this device would be established by:

Reference Methods: Highly accurate and precise laboratory methods used to assign target values to the various levels of the control material.
Gravimetric and Volumetric Standards: Precise measurements during formulation.
Interlaboratory Consensus: In some cases, target values might be confirmed through round-robin studies among multiple qualified laboratories.
Traceability: Ensuring the values are traceable to internationally recognized reference materials or methods.

It is not based on expert consensus in a clinical diagnostic sense, pathology, or outcomes data.

8. The sample size for the training set

This concept is not applicable here. A "training set" refers to data used to train a machine learning model. This device is a chemical control material, not a machine learning algorithm. Its development involves chemical formulation and analytical testing, not statistical training data sets in the AI sense.

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

Not applicable, as there is no "training set" in the context of this chemical control material.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company. The word "maine" is on the top left, with a horizontal line underneath it. A diagonal line goes from the top right of "maine" to the bottom left of "standards", which is on the bottom right. Underneath "standards" is the word "COMPANY".

JUN 2 5 2009

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: _ 09 1225

Submitter:	Maine Standards Company
Address:	765 Roosevelt TrailWindham, ME 04062
Telephone:	207-892-1300
Fax:	207-892-2266
Contact:	Holly Cressman

Summary prepared on: April 17, 2009

Device classification name: Multi-Analyte Controls, All Kinds (Assayed and Unassayed) Device description: Quality control material (assayed and un-assayed)*

VALIDATE® GC1 Calibration Verification / Linearity Test Set Proprietary Name: VALIDATE® GC2 Calibration Verification / Linearity Test Set VALIDATE® GC3 Calibration Verification / Linearity Test Set VALIDATE® GC4 Calibration Verification / Linearity Test Set

Regulation Number:	21 CFR 862.1660
Product Code:	JJY*
	*Note: There is no FDA product code for colibra

Note: There is no FDA product code for calibration verification / 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 |

Predicate Devices:

VALIDATE® Chem 1 Calibration Verification / Linearity Test Set, Maine Standards Company, Windham, ME. WHEIDATE® Chem 1 Calibration / Linearity Test Set, Maine Standards Company, Windham, ME. VALIDATE® Chem 3 Calibration Verification / Linearity Test Set, Maine Standards Company, Windham, ME. VALIDATE® Chem 4 Calibration Verification / Linearity Test Set, Maine Standards Company, Windham, ME. VALIDATE® Chem 5 Calibration Verification / Linearity Test Set, Maine Standards Company, Windham, ME. VALIDATE® Chilibration Verification / Linearity Test Set, Maine Standards Company, Windham, M.C.
VALIDATE® Collination Verification / Linearity Test Set, Maine Standards Co 77 Libration of Calibration Verification / Linearity Toot Oot, Maine Standards Company, Windham, ME.

**Note: The VALIDATE® CHEM 4 K012120 that was filed contained the following analytes: ALT, AST, CK, LD, ALP, AMY, GGT, LIP, TBIL, and DBIL. Later, the TBIL and DBIL analytes were split off into a stand alone product called VALIDATE® CHEM 5.

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Device description: VALIDATE® GC Calibration Verification / Linearity Test Sets are human and aqueous 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.

Intended use: Validate® GC Calibration Verification / Linearity Test Sets are intended for in vitro diagnostic use in the guantitative determination of linearity, calibration verification of reportable range in automated, semi automated, and manual chemistry systems. See attached 510k submission for the list of all analytes claimed.

Summary:

The VALIDATE® GC Calibration Verification / Linearity Test Sets behave in a manner suitable for the evaluation of calibration, verification of reportable range, and the linear response of the listed analytes over the ranges tested when compared to the predicate devices. VALIDATE® GC Calibration Verification / Linearity Test Sets are as safe, as effective, and perform as well as or better than the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 25 2009

Maine Standards Company c/o Ms. Holly A. Cressman Manager QA/RA 765 Roosevelt Trail Windham, ME 04062

Re: K091225

Trade/Device Name: VALIDATE GC1 Calibration Verification/Linearity Test Set, GC2 Calibration Verification/Linearity Test Set, GC3 Calibration Verification/Linearity Test Set and GC4 Calibration Verification/Linearity Test Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: April 17, 2009 Received: April 27, 2009

Dear Ms. Cressman:

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

G.C.H.

Courtney C. Harper, Ph.D. Acting 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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Indication for Use

510(k) Number (if known): 《○91乙乙5

Device Name:

VALIDATE® GC1 Calibration Verification / Linearity Test Set VALIDATE® GC2 Calibration Verification / Linearity Test Set VALIDATE® GC3 Calibration Verification / Linearity Test Set VALIDATE® GC4 Calibration Verification / Linearity Test Set

Indication For Use:

Prescription Use X

And/Or

Over the Counter Use

(21 CFR Part 801 Subpart D)

(21 CFR Part 801

Subpart C)

(Please Do Not WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

signature

Dision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091225

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.