FASTPACK TESTO IMMUNOASSAY

K101388 · Qualigen, Inc. · CDZ · Feb 18, 2011 · Clinical Chemistry

Device Facts

• Record ID: K101388
• Device Name: FASTPACK TESTO IMMUNOASSAY
• Applicant: Qualigen, Inc.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Feb 18, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Intended Use

The FastPack® Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack® Testo Immunoassay is designed for use with the FastPack® System.

Device Story

FastPack® Testo Immunoassay is a competitive chemiluminescence assay for quantitative testosterone measurement in human serum or plasma. Device utilizes disposable packs containing paramagnetic particles with covalently coupled testosterone, alkaline phosphatase-labeled monoclonal antibody, wash buffer, and ImmuGlow™ substrate. Operation occurs on FastPack® Analyzer; sample and antibody solution undergo primary incubation; reaction mixture added to paramagnetic particles for secondary incubation; unbound materials washed away; chemiluminogenic substrate added; analyzer measures resulting 'glow' at 37°C. Amount of bound labeled-antibody is inversely proportional to testosterone concentration. Used in professional clinical settings to assist physicians in diagnosing and managing androgen-related conditions. Provides quantitative results to inform clinical decision-making regarding hormone status.

Clinical Evidence

Bench testing only. Validation included method comparison, precision, linearity, limits of blank/detection/quantitation, and analytical specificity to confirm performance with lithium heparin and K2 EDTA plasma matrices compared to serum.

Technological Characteristics

Paramagnetic particle chemiluminescent immunoassay. Components: paramagnetic particles with covalently coupled testosterone, mouse monoclonal antibody labeled with alkaline phosphatase, Tris wash buffer, and ImmuGlow™ (indoxyl-3-phosphate and lucigenin) substrate. Preservatives: 0.1% sodium azide, 0.03% Proclin® 150. Operates at 37°C on FastPack® Analyzer. Professional use only.

Indications for Use

Indicated for quantitative determination of total testosterone in human serum and plasma to aid in diagnosis and treatment of androgenic hormone disorders, including hypogonadism, puberty disorders, cryptorchidism, hirsutism, virilization, and testicular or adrenal tumors.

Regulatory Classification

Identification

A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Predicate Devices

• FastPack® Testo Immunoassay (K021972)

Submission Summary (Full Text)

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K101388

Image /page/0/Picture/1 description: The image shows the word "Qualigen" in a stylized, bold, black font. The "Q" is large and has a swooping tail that underlines the rest of the word. The letters are slightly slanted to the right, giving the word a dynamic appearance. The overall impression is of a company name or brand logo.

# FEB 18 2011

### 510(k) SAFETY AND EFFECTIVENESS 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.

- Submitter's Name, Address, Telephone Number, Contact Person and date the summary l. was prepared.

| Submitter's Name: | Qualigen, Inc. |
|----------------------------|-------------------------------------------------------------------------------|
| Address: | 2042 Corte Del Nogal<br>Carlsbad, CA 92011<br>(760)-918-9165 |
| Contact Person: | Michael Poirier<br>Senior Vice President, CSO/CTO<br>[e-mail] |
| Date the summary prepared: | February 18, 2011 |
| Device Name | |
| Trade/Proprietary Name: | FastPack® Testo Immunoassay |
| Common/Usual Name: | Total Testosterone Immunoassay |
| Classification Name: | Total Testosterone Immunoassay, §21 CFR 862.1690 |
| Class: | Class II |
| Trade/Proprietary Name: | FastPack® Testo Immunoassay |
| Common/Usual Name: | Total Testosterone Immunoassay |
| Classification Name: | Total Testosterone Immunoassay, §21 CFR 862.1690 |
| Class: | Class II |

- 3. Predicate Device:
2.

FastPack® Testo Immunoassay K021972 510(k) number:

agi 2008 Socie 8 - Lansional CA 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 Of 4 For Startis V. .

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#### 4. Device Description

The FastPack® Testo Immunoassay for the quantitative determination of testosterone in human serum, lithium heparin plasma and K2 EDTA plasma is designed for use on the FastPack® Analyzer.

#### FastPack® Testo Immunoassay Reagents

The FastPack® Testo Immunoassay Reagents are contained in a disposable pack (FastPack®). Each FastPack® contains the following four components:

- 1. Paramagnetic Particles, 150 uL Paramagnetic particles with covalently coupled testosterone in buffer containing 0.1% sodium azide as a preservative.
- 2. Testosterone Antibody Solution, 100 uL Antibody solution containing mouse monoclonal antibody labeled with alkaline phosphatase in a protein matrix containing 0.03% Proclin® 150 as a preservative.
- Wash Buffer, 2.0 mL 3. Tris buffer containing surfactants.
- Substrate, 140 uL 4. ImmuGlow™: Indoxyl-3-phosphate and lucigenin in buffer containing preservatives.

The FastPack® Testo Immunoassay is a competitive chemiluminescence assay.

- Primary incubation: Antibody solution (a buffer solution containing a . monoclonal C3-testosterone-specific antibody labeled with alkaline phosphatase )[100 uL] reacts with testosterone from the patients sample, control, or calibrator [100 uL].
- Secondary incubation: The reaction mixture is added to paramagnetic particle . with covalently coupled testosterone. During this incubation, the testosteronecoated beads compete with the sample testosterone.
- Removal of unbound materials: The paramagnetic particles are washed with . wash buffer [0.2 mL/wash] to remove unbound materials.
- Substrate addition and detection: Chemiluminogenic substrate [140 µL] is added . to the solid-phase bound complex and results in "glow" chemiluminescence, which is measured using the FastPack® Analyzer at 37℃.
- The amount of bound labeled-antibody is inversely proportional to the . concentration of testosterone in the sample.

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#### 5. Intended Use:

The FastPack® Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack® Testo Immunoassay is designed for use with the FastPack® System.

- 6. Assessment of Performance:
An evaluation of the FastPack® Testo Immunoassay was conducted in-house. The studies demonstrated the safety and effectiveness of the device when used as intended.

- 7. Comparison to Predicate Device.

| CHARACTERISTIC | Qualigen FastPack® Testo<br>Immunoassay Serum or Plasma | Qualigen FastPack® Testo Serum<br>Only K021972 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | for the in-vitro quantitative<br>determination of total testosterone in<br>human serum or lithium-heparin or<br>K2 EDTA plasma. The FastPack®<br>Testo Immunoassay is designed for<br>use with the FastPack® System. | for the in-vitro quantitative<br>determination of total testosterone in<br>human serum. The FastPack® Testo<br>Immunoassay is designed for use<br>with the FastPack® System. |
| Indications for Use | Quantitative determination of total<br>testosterone. | Quantitative determination of total<br>testosterone. |
| Sample | Serum or plasma (heparin or K2<br>EDTA) | Serum |
| Sample Preparation | Standard processing for serum or<br>plasma | Standard processing for serum |
| Calibration | An active calibration is required<br>every 14 days and with each new lot;<br>system includes calibration solutions<br>and instructions. | An active calibration is required<br>every 14 days and with each new lot;<br>system includes calibration solutions<br>and instructions. |
| Methodology | The FastPack® Testo Immunoassay<br>is a paramagnetic particle,<br>chemiluminescent immunoassay. | The FastPack® TestoImmunoassay is<br>a paramagnetic particle,<br>chemiluminescent immunoassay. |
| Testing Environment | Professional use | Professional use |
| Measuring Range | 23 ng/dL to 1600 ng/dL | 23 ng/dL to 1600 ng/dL |
| Precision | Total imprecision is 10.9% CV at<br>712 ng/dL (high sample) and 0.07<br>SD at 14 ng/dL (low sample) | Total imprecision is 10.9% CV at 712<br>ng/dL (high sample) and 0.07 SD at<br>14 ng/dL (low sample) |
| Linearity | Assay linear throughout dynamic<br>range | Assay linear throughout dynamic<br>range |

## Similarities / Differences between EastPack® Testo Serum & Plasma Assays

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| Interfering Substances | No interference from Bilirubin up to<br>concentrations of 10mg/dL. No<br>interference from Hemoglobin up<br>to concentrations of 250mg/dL.<br>Triglyceride demonstrated<br>interference for all concentrations of<br>interferent tested at < 100 ng/dL of<br>testosterone. Based on these studies,<br>no visibly hemolyzed or cloudy<br>(lipemic) samples should be used<br>with this assay. | No interference from Bilirubin up to<br>concentrations of 10mg/dL. No<br>interference from Hemoglobin up<br>to concentrations of 250mg/dL.<br>Triglyceride demonstrated<br>interference for all concentrations of<br>interferent tested at < 100 ng/dL of<br>testosterone. Based on these studies,<br>no visibly hemolyzed or cloudy<br>(lipemic) samples should be used<br>with this assay. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cross-reactivity | No significant cross-reactivity from<br>high levels of 5-α-DHT.<br>Androstenediol and 19-<br>Norethisterone Acetate generated the<br>highest cross-reactivity in this study<br>though although the magnitude was<br>limited to <4%. | No significant cross-reactivity from<br>high levels of 5-α-DHT.<br>Androstenediol and 19-<br>Norethisterone Acetate generated the<br>highest cross-reactivity in this study<br>though although the magnitude was<br>limited to <4%. |
| Comparative Testing vs | Serum | Serum |
| Established Methods | N = 135 | N = 135 |
| | Range of observations: | Range of observations: |
| (Deming Regressions) | 24.0 - 1587.2 ng/dL | 24.0 - 1587.2 ng/dL |
| | Slope: 1.054 | Slope: 1.054 |
| | y-intercept: 6.5<br>$r² = 0.914$ | y-intercept: 6.5<br>$r² = 0.914$ |
| | | |
| | Lithium Heparin Plasma vs Serum<br>N = 60<br>Range of observations:<br>24.0 - 1440.0 ng/dL<br>Slope: 0.992<br>y-intercept: -8.0<br>$r² = 0.987$<br><br>K2 EDTA Plasma vs Serum<br>N = 67<br>Range of observations:<br>27.5 - 1425.0 ng/dL<br>Slope: 0.998<br>y-intercept: - 10.9<br>$r² = 0.996$ | Lithium Heparin Plasma vs Serum<br>N = 60<br>Range of observations:<br>24.0 - 1440.0 ng/dL<br>Slope: 0.992<br>y-intercept: -8.0<br>$r² = 0.987$<br><br>K2 EDTA Plasma vs Serum<br>N = 67<br>Range of observations:<br>27.5 - 1425.0 ng/dL<br>Slope: 0.998<br>y-intercept: - 10.9<br>$r² = 0.996$ |

- 8. Conclusions
The results of the evaluation studies of the FastPack® Testo Immunoassay demonstrate
that the device is equivalent in performance to the predicate device and suitable for its intended use.

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Public Health Service

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circle around the eagle.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Qualigen, Inc. c/o Mr. Michael S. Poirier Senior Vice President 2042 Corte Del Nogal, Suite B Carlsbad, CA 92011-1438

Re: k101388

Trade/Device Name: Fastpack® Testo Immunoassay Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone test system Regulatory Class: I, reserved Product Code: CDZ Dated: February 3, 2011 Received: February 4, 2011

FEB 18 201

Dear Mr. Poirier:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 –

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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). 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/ReportalProblem/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/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology 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): K101388

#### Device Name:

#### Indications for Use:

The FastPack® Testo Immunoassay is a paramagnetic particle immunoassay for the invitro quantitative determination of total testosterone in human serum or plasma. The FastPack® Testo Immunoassay is designed for use with the FastPack® System. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

Prescription Use XX Use (Part 21 CFR 801 Subpart D) Subpart C)

AND/OR

Over -the-Counter

(Part 21 CFR 801

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of 1 of Intended Use

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_K 101 388