FASTPACK TOTAL PSA METHOD VERIFICATION KIT

K062957 · Qualigen, Inc. · JJX · Apr 2, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062957
• Device Name: FASTPACK TOTAL PSA METHOD VERIFICATION KIT
• Applicant: Qualigen, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 2, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The FastPack® Total PSA Method Verification Kit consists of assayed quality control materials for verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay to meet CLIA requirements.

Device Story

Qualigen FastPack Total PSA Method Verification Kit provides assayed quality control materials for verifying calibration and reportable range of FastPack Total PSA Immunoassay. Kit contains three liquid, ready-to-use verifiers at 0, 25, and 50 ng/mL concentrations. Verifiers consist of human PSA purified from seminal fluid in TRIS buffer with bovine serum albumin and 0.1% sodium azide preservative. Used with FastPack analyzer by laboratory personnel to ensure assay performance meets CLIA requirements. Value assignment involves running verifiers across multiple analyzers and lots, calculating mean concentrations, and ensuring results fall within specified acceptable limits. Device provides standardized reference points to confirm accuracy of PSA measurements in clinical settings.

Clinical Evidence

No clinical data. Bench testing only. Performance established via value assignment protocols using multiple analyzers and lots to calculate robust means and ensure results fall within specified concentration ranges. Stability supported by accelerated studies at 25°C, 30°C, and 37°C, with real-time testing ongoing.

Technological Characteristics

Liquid, ready-to-use assayed quality control material. Composition: Human PSA (purified from seminal fluid), TRIS buffer, bovine serum albumin, 0.1% sodium azide. Three levels: 0, 25, 50 ng/mL. Used with FastPack analyzer. Storage: 4°C.

Indications for Use

Indicated for use as assayed quality control materials to verify calibration and reportable range of the FastPack® Total PSA Immunoassay in clinical laboratory settings to meet CLIA requirements.

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

• FastPack® PSA Controls (k003095)

Submission Summary (Full Text)

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K062957

APR - 2 2007

# 510(k) Summary

## FastPack® Total PSA Method Verification Kit

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| 1. | Submitter<br>name, address,<br>contact | Qualigen, Incorporated<br>2042 Corte del Nogal<br>Carlsbad, CA 92011 | |
|----|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| | | Telephone:<br>Fax: | [phone]<br>[phone] |
| | | Contact Person: | Melissa Saam |
| | | Date Prepared: | September 28, 2006 |
| 2. | Device name | Proprietary name: | FastPack® Total PSA Method Verification Kit |
| | | Common name: | Total PSA Quality Controls |
| | | Classification Name: | Single (specified) Analyte Controls (assayed and<br>unassayed) |
| 3. | Predicate<br>device | FastPack® Controls | |
| 4. | Device<br>description | FastPack® PSA Method Verification Kit<br>The FastPack® Total PSA Method Verification kit components are in liquid<br>form, in vials, from which the user can directly remove sample. They are<br>formulated at three (3) levels packaged together as a kit. | |
| 5. | Intended use | The FastPack® Total PSA Method Verification Kit consists of assayed<br>quality control materials for verification of the calibration and reportable<br>range of the FastPack® Total PSA Immunoassay to meet CLIA<br>requirements. | |

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#### The following table compares the FastPack® PSA Method Verification Kit 6. Comparison with the FastPack® Calibrators. to Predicate

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Device

| Feature | Predicate Device | New Device |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | FastPack® Controls | FastPack® Total PSA<br>Method Verification Kit |
| Intended Use | Assayed quality control<br>materials for the verification<br>of the accuracy and<br>precision of the FastPack®<br>Analyzer system when used<br>for the quantitative<br>determination of PSA in<br>human serum or plasma. | Assayed quality control<br>materials for the<br>verification of the<br>calibration and reportable<br>range of the FastPack®<br>Total PSA Immunoassay<br>to meet CLIA<br>requirements. |
| Analytes | Total PSA | Total PSA |
| Matrix | Bovine Serum Albumin | Bovine Serum Albumin |
| Form | Liquid | Liquid |
| Volume | 5.0 mL | 5.0 mL |
| Levels | 2 | 3 |
| PSA | 2 ng/mL | 0 ng/mL |
| Concentrations | 10 ng/mL | 25 ng/mL |
| | | 50 ng/mL |

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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 is circular and features the department's name around the perimeter. In the center of the logo is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# APR - 2 2007

Qualigen, Inc. c/o Ms. Melissa Saam Manager, QA/RA 2042 Corte Del Nogal Carlsbad, CA 92011

Re: k062957

Trade/Device Name: Qualigen™ FastPack® Total PSA Method Verification Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: March 13, 2007 Received: March 19, 2007

Dear Ms. Saam:

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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The

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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

ia M chan
for Dr Robert Becker

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):

K062957

Device Name: FastPack® Total PSA Method Verification Kit

Indications for Use:

The FastPack® Total PSA Method Verification Kit consists of assayed quality control materials for verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay to meet CLIA requirements.

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 Device Evaluation (ODE)

Mona M. Chan
Division Sign-Off

510(k)

Office of In Vitro Diagnostic Device Evaluation and Safety

062957

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