VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406

K123127 · Maine Standards Co. · JJX · Jun 14, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123127
• Device Name: VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
• Applicant: Maine Standards Co.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended 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 prostrate-specific antigen (PSA) and free prostrate-specific antigen (fPSA) on automated systems.

Device Story

The VALIDATE PSA Calibration / Linearity Test Kit consists of purified PSA and fPSA chemicals in a human serum base. It is provided in multiple levels to establish the relationship between theoretical and actual performance of automated clinical analyzer systems. The kit is used by laboratory professionals to verify the reportable range and linear response of PSA assays. By comparing the measured values of the test kit levels against expected values, clinicians can ensure the accuracy and reliability of patient PSA testing results, facilitating appropriate clinical decision-making for prostate health monitoring.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

The device consists of purified PSA and fPSA in a human serum base. It is a multi-level, liquid, ready-to-use test kit designed for use on automated clinical chemistry systems. No specific energy source or software algorithm is involved in the test kit itself; it serves as a reference material for system verification.

Indications for Use

Indicated for in vitro diagnostic use to verify linearity, calibration, and reportable range of total PSA and free PSA assays on automated clinical systems.

Regulatory Classification

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.

Predicate Devices

• VALIDATE® Chem 6 Calibration Verification Test Set (k013119)

Submission Summary (Full Text)

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## 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: [phone] 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.

11

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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 [phone] or [phone] 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 [phone] or [phone] 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