FASTPACK TESTOSTERONE CALIBRATOR

K022533 · Qualigen, Inc. · JIT · Sep 30, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022533
• Device Name: FASTPACK TESTOSTERONE CALIBRATOR
• Applicant: Qualigen, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Sep 30, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The FastPack® Total Testosterone Calibrator is intended to calibrate the FastPack® Analyzer system when used for the quantitative determination of testosterone in human serum.

Device Story

FastPack® Testosterone Calibrator is a liquid-form calibrator used to calibrate the FastPack® Analyzer system. It consists of total testosterone in a buffered bovine serum albumin matrix. The device is used in a clinical laboratory setting by trained personnel to establish the calibration curve required for the quantitative measurement of testosterone in human serum samples. By ensuring the accuracy of the analyzer's output, the calibrator supports clinicians in making diagnostic decisions regarding testosterone levels in patients.

Technological Characteristics

Liquid-form calibrator; contains total testosterone in buffered bovine serum albumin matrix; 2.5 mL volume; single-level calibration; intended for use with the FastPack® Analyzer system.

Indications for Use

Indicated for the calibration of the FastPack® Analyzer system for the quantitative determination of testosterone in human serum.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Diagnostic Products Corporation's Coat-A-Count Total Testosterone RIA Kit (K844423), Calibrator component

Submission Summary (Full Text)

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KO22533

SEP 3 0 2002

# 510(k) Summary

## FastPack® Testosterone Calibrator

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,<br>address,<br>contact | Qualigen, Incorporated<br>2042 Corte del Nogal<br>Carlsbad, CA 92009 | |
|----|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| | Telephone:<br>Fax: | [phone]<br>[phone] | |
| | Contact Person: | Dorothy Deinzer | |
| | Date Prepared: | July 23, 2002 | |
| 2. | Device<br>name | Proprietary name: | FastPack® Testosterone Calibrator |
| | | Common name: | Calibrator |
| | | Classification Name: | Calibrator, Secondary |
| 3. | Predicate<br>device | Diagnostic Products Corporation's Coat-A-Count Total Testosterone<br>RIA Kit (K844423), Calibrator component | |
| 4. | Intended<br>use | The FastPack® Total Testosterone Calibrator is intended to calibrate<br>the FastPack® Analyzer system when used for the quantitative<br>determination of testosterone in human serum. | |

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- The following table compares the FastPack® Testosterone 5. Comparison to Calibrator with the calibrator component of the DPC Coat-A-Predicate Count® Total Testosterone: Device

| Feature | FastPack®<br>Testosterone<br>Calibrator | DPC Coat-A-Count,<br>Calibrator Component |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For calibration of the<br>FastPack® Analyzer<br>system when used for<br>the quantitative<br>determination of<br>testosterone in human<br>serum. | The testosterone calibrator<br>is intended to prepare the<br>standard curve for the DPC<br>Coat-A-Count assay kit for<br>determination of total<br>testosterone in human serum<br>or heparinized plasma. |
| Analyte<br>Matrix | Total Testosterone<br>Buffered Bovine Serum<br>albumin | Total Testosterone<br>Human serum – based |
| Form | Liquid | Liquid |
| Volume | 2.5 mL | 0 level, 4.0 mL<br>Other levels, 1.0 mL |
| Levels | 1 | 6 |

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes emanating from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Dorothy Deinzer Director of Quality Assurance and Regulatory Affairs Qualigen, Inc. 2042 Corte Del Nogal Carlsbad, CA 92009

SEP 3 0 2002

Re: k022533

Trade/Device Name: FastPack® Testosterone Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: July 30, 2002 Received: July 31, 2002

Dear Ms. Deinzer:

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 (OS) 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrlv/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Attachment 4

### Indications for Use Statement

| 510(k) Number | K022533 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | FastPack® Testosterone Calibrator |
| Indications for Use | The FastPack® Testosterone Calibrator is intended to calibrate the FastPack® Analyzer system when used for the quantitative determination of Testosterone in human serum. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Acan Copy
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022533

Prescription Use ***_***
(Per 21 CFR 801.109)
OR
Over-The-Counter Use **_**