(253 days)
VALIDATE PSA Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analytes: Total prostate-specific antigen (PSA) and free prostate-specific antigen (fPSA) on automated systems.
Quality control material (assayed and un-assayed)*
Each VALIDATE® PSA Calibration / Linearity Test Kit contains purified chemicals in a human serum base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.
This document describes the VALIDATE® PSA Calibration Verification / Linearity Test Kit, a device intended for in vitro diagnostic use to verify calibration and linearity of automated systems for measuring Total Prostate-Specific Antigen (PSA) and free Prostate-Specific Antigen (fPSA).
Here's an analysis of the provided information relating to acceptance criteria and the study:
Acceptance Criteria and Device Performance
The provided document describes the device as behaving "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." However, specific numerical acceptance criteria (e.g., % bias, correlation coefficients, or specific ranges of linearity) are not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed quantitative acceptance criteria for its own performance.
Therefore, the table below reflects what can be inferred.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Suitable for evaluation of calibration, verification of reportable range, and linear response for Total PSA and fPSA. (Implied by intended use and summary of safety/effectiveness) | "The VALIDATE® PSA Calibration / Linearity Test Kit 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® PSA Calibration Verification / Linearity Test Kit is as safe and effective as the predicate device." (Implied to meet the same or comparable performance standards as the predicate). |
Study Details
The provided text is a 510(k) summary, which often focuses on demonstrating substantial equivalence rather than providing a detailed study report. As such, many of the requested details about the study are not explicitly present in the provided document.
Here's what can be extracted or inferred:
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The description mentions "Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes." This suggests that a series of concentrations were tested, but the number of replicates or distinct samples is not specified.
- Data Provenance: Not explicitly stated, but given that it's a submission to the FDA by a US company (Maine Standards Company), it implies the study was likely conducted with data relevant to the U.S. market. The study is retrospective in the sense that the results were generated and then submitted to the FDA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not stated. For calibration verification kits, "ground truth" is typically established by the known concentrations of the analytes in the manufactured control materials, rather than expert interpretation of a biological sample. The accuracy of these known concentrations would be verified through reference methods and quality control procedures during manufacturing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not stated. Adjudication methods are typically relevant for studies where subjective interpretation (e.g., medical imaging) forms the basis of ground truth. For a linearity/calibration verification kit, the assessment is based on quantifiable measurements against expected values.
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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:
- No. This type of study is completely irrelevant for a calibration verification/linearity test kit. MRMC studies are used for evaluating diagnostic aids, often involving human interpretation of images or other data with and without AI assistance. This device is a quality control material.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not stated in these terms. The "performance" of this device is its inherent chemical and physical stability and its ability to provide accurate and linear responses across different analytes when measured by automated systems. The study likely involves running the kit on various automated systems and comparing the results to expected values and to the predicate device's performance. It's an "algorithm only" in the sense that the automated systems are the "algorithms" that process the kit, but the kit itself isn't an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this type of device is the assigned target values/concentrations for each analyte at each level of the kit, established during the manufacturing process through precise analytical methods and verified against reference standards (e.g., gravimetric measurements, certified reference materials).
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The sample size for the training set:
- Not applicable / Not stated. This device is not an AI algorithm that requires a "training set." It is a physical chemical product.
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How the ground truth for the training set was established:
- Not applicable / Not stated. As above, it's not an AI algorithm requiring a training set. The "ground truth" for the device's performance is tied to the manufacturing and characterization of the control material itself.
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Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company. The logo is black and white and features the word "maine" on top of a horizontal line. A diagonal line extends from the top right of the word "maine" to the bottom left of the word "standards" which is below the horizontal line. The word "COMPANY" is below the word "standards" in a smaller font.
JUN 1 4 2013
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: K123127."
- Submitter: Maine Standards Company Address: 765 Roosevelt Trail Windham, ME 04062
207-892-1300 Telephone: 207-892-2266 Fax:
Contact: James Champlin
Summary prepared on: June 14, 2013
| Device classification name: | Multi-Analyte Controls, All Kinds (Assayed and Unassayed) |
|---|---|
| Device description: | Quality control material (assayed and un-assayed)* |
| Proprietary Name: | VALIDATE® PSA Calibration Verification / Linearity Test Kit |
| Regulation Number: | 21 CFR 862.1660 |
Product Code: JJX*
*Note: There is no FDA product code for calibration / linearity materials. Therefore, as with previous submissions by Maine Standards Company and other calibration verification / linearity manufacturers, JJX was selected as the "best fit" FDA code for this product.
Regulatory Class: Class I
Predicate Device:
VALIDATE® Chem 6 Calibration / Linearity Test Kit, Maine Standards Company, Windham, ME.
Device description: Each VALIDATE® PSA Calibration / Linearity Test Kit contains purified chemicals in a human serum base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.
Intended use:
VALIDATE PSA Calibration / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analytes: Total prostate-specific antigen (PSA) and free prostate-specific antigen (fPSA) on automated systems.
Summary:
The VALIDATE® PSA Calibration / Linearity Test Kit 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® PSA Calibration Verification / Linearity Test Kit is as safe and effective as the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2013
MAINE STANDARDS COMPANY, LLC C/O MR. JAMES W. CHAMPLIN MANAGER, QA & RA 765 ROOSEVELT TRAIL WINDHAM ME 04062
Re: K123127
Trade/Device Name: VALIDATE PSA Calibration Verification/ Linearity Test Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: II Product Code: JJX Dated: May 24, 2013 Received: May 24, 2013
Dear Mr. Champlin:
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 andadulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Maria.M.Chan -S
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123127
Device Name: VALIDATE® PSA Calibration Verification / Linearity Test Kit
Indications For Use:
VALIDATE PSA Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analytes: Total prostate-specific antigen (PSA) and free prostate-specific antigen (fPSA) on automated systems.
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=AN0THER=PAGE=1F= NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Maria M. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k): K123127
§ 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.