(97 days)
VALIDATE® GC3 Calibration Verification / Linearity Test Kit is intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range. See the package insert for the list of all analytes claimed.
Each VALIDATE® GC 3 Calibration Verification / Linearity Test Kit contains purified chemicals in a human serum albumin base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.
This document is a 510(k) summary for the VALIDATE® GC3 Calibration Verification / Linearity Test Kit. It focuses on establishing substantial equivalence to a predicate device, rather than providing details of a standalone study for performance. Therefore, many of the requested data points related to a specific study design (e.g., sample sizes for test/training sets, expert consensus, MRMC studies) are not present.
However, I can extract the available information and state where the requested details are not provided within this document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria or device performance in the format typically seen for a new medical device study with specific metrics like sensitivity, specificity, or AUC. Instead, it states that the device behaves in a manner suitable for its intended use and is "as safe, as effective, and perform as well as or better than the predicate device." This indicates the acceptance criterion was likely substantial equivalence to the predicate device based on its performance characteristics for linearity, calibration verification, and reportable range verification.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device behaves in a manner suitable for evaluating calibration. | The VALIDATE® GC3 Calibration Verification / Linearity Test Kits behave in a manner suitable for the evaluation of calibration of the listed analytes over the ranges tested when compared to the predicate device. VALIDATE® GC3 Calibration Verification / Linearity Test Kits perform as well as or better than the predicate device. |
| Device behaves in a suitable manner for reportable range verification. | The VALIDATE® GC3 Calibration Verification / Linearity Test Kits behave in a manner suitable for the evaluation of verification of reportable range of the listed analytes over the ranges tested when compared to the predicate device. VALIDATE® GC3 Calibration Verification / Linearity Test Kits perform as well as or better than the predicate device. |
| Device behaves in a suitable manner for linear response verification. | The VALIDATE® GC3 Calibration Verification / Linearity Test Kits behave in a manner suitable for the evaluation of the linear response of the listed analytes over the ranges tested when compared to the predicate device. VALIDATE® GC3 Calibration Verification / Linearity Test Kits perform as well as or better than the predicate device. |
| Device is as safe and effective as the predicate device. | The VALIDATE® GC3 Calibration Verification / Linearity Test Kits are as safe, as effective, and perform as well as or better than the predicate device. (This is a summary statement indicating successful comparison to a predicate, rather than an explicit performance metric in itself). |
2. Sample size used for the test set and the data provenance
This document does not provide details on the specific sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The determination of substantial equivalence likely involved internal testing and comparison with the predicate device's established performance, rather than a clinical trial with a defined test set of patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a quality control material intended to verify the performance of other in vitro diagnostic devices. Its "ground truth" relates to its chemical composition and its expected behavior on a diagnostic instrument, rather than clinical interpretation by experts.
4. Adjudication method for the test set
Not applicable, as no external test set requiring expert adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a quality control material, not an AI-powered diagnostic tool, and therefore MRMC studies or human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A "standalone" performance evaluation was effectively done in the context of comparing the new device's performance to the predicate. The device's performance (its ability to demonstrate linearity, verify calibration, and define reportable range) was measured directly on analytical instruments, independent of human interpretation of complex images or data. The summary statement "The VALIDATE® GC3 Calibration Verification / Linearity Test Kits 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 device" serves as the high-level conclusion of this evaluation. Specific methods and results (e.g., linearity plots, statistical comparisons) would typically be found in the full 510(k) submission, not in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this type of device (calibration verification/linearity test kit) is based on:
- Chemical composition and known analyte concentrations: The kit contains purified chemicals at specific, known concentrations across multiple levels. These concentrations are the "ground truth" against which the instrument's measurements are challenged to verify linearity and calibration.
- Predicate device's established performance: The new device's performance is compared to a legally marketed predicate device, with the predicate's established performance serving as a benchmark for "ground truth" in the context of substantial equivalence.
8. The sample size for the training set
Not applicable. This device is a ready-to-use quality control material, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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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 line, with a horizontal line underneath it. The word "standards" is on the second line, with the word "company" underneath it in smaller letters.
JUL - 5 201
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: 长川の母 8D
| Submitter: | Maine Standards Company |
|---|---|
| Address: | 765 Roosevelt TrailWindham, ME 04062 |
207-892-1300 Telephone: 207-892-2266 Fax:
Holly Cressman Contact:
Summary prepared on: March 23, 2011
Multi-Analyte Controls. All Kinds (Assayed and Unassayed) Device classification name: Device description: Quality control material (assaved and un-assayed)*
VALIDATE® GC3 Calibration Verification / Linearity Test Kit Proprietary Name:
Regulation Number: 21 CFR 862.1660
: : Product Code: JJY*
*Note: There is no FDA product code for calibration verification / linearity materials. Therefore, as with previous submissions by Maine Standards Company and other calibration / linearity manufacturers, JJY has been selected as the "best fit" FDA code for this product.
Regulatory Class: Class I
Predicate Devices:
VALIDATE® GC3 Calibration Verification / Linearity Test Kit, Maine Standards Company, Windham, ME.
Device description: Each VALIDATE® GC 3 Calibration Verification / Linearity Test Kit contains purified chemicals in a human serum albumin base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.
Intended use: VALIDATE® GC3 Calibration Verification / Linearity Test Kits are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range. See the package insert for the list of all analytes claimed.
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Summary:
The VALIDATE® GC3 Calibration Verification / Linearity Test Kits 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 device. VALIDATE® GC3 Calibration Verification / Linearity Test Kits are as safe, as effective, and perform as well as or better than the predicate device.
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
JUL 0 5 2011
Maine Standards Company, LLC c/o Ms. Holly Cressman Manager Quality Assurance/Regulatory Affairs 765 Roosevelt Trail Windham, Maine 04062
Re: K110880
Trade Name: Validate ® GC3 Calibration Verification/Linearity Test Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class I, reserved Product Codes: JJY Dated: May 26, 2011 Received: June 01, 2011
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, 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
KILO880 510(k) Number:
Device Name: VALIDATE® GC3 Calibration Verification / Linearity Test Kit
Indications For Use:
VALIDATE® GC3 Calibration Verification / Linearity Test Kit is intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range. See the package insert for the list of all analytes claimed.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) KIID 880
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§ 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.