(253 days)
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No
The summary describes a calibration and linearity test kit for in vitro diagnostic use, which is a quality control material. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on verifying the performance of automated systems for PSA testing.
No
This device is an in vitro diagnostic test kit used for calibration and linearity verification of automated systems that measure PSA levels. It is a quality control material and not a device used for therapy.
No
Explanation: This device is a calibration and linearity test kit used to verify the performance of automated systems for determining PSA levels. It is an in vitro diagnostic (IVD) product but acts as a quality control material rather than directly diagnosing a patient's condition.
No
The device description explicitly states it is a "Quality control material" containing "purified chemicals in a human serum base," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the solutions are "intended for in vitro diagnostic use".
- Device Description: The device is described as "Quality control material (assayed and un-assayed)*" and is used to "establish the relationship between theoretical and actual performance" of analytes. This is consistent with the function of an IVD used for quality control and calibration verification in laboratory testing.
- Intended User / Care Setting: The "Intended User / Care Setting" section also states "in vitro diagnostic use".
All of these points clearly indicate that the device is designed and intended for use in diagnostic procedures performed outside of the living body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JJX
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
VALIDATE® Chem 6 Calibration / Linearity Test Kit
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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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.
2
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