FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

K994419 · Qualisys Diagnostics, Inc. · LTJ · Jun 28, 2000 · Immunology

Device Facts

• Record ID: K994419
• Device Name: FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
• Applicant: Qualisys Diagnostics, Inc.
• Product Code: LTJ · Immunology
• Decision Date: Jun 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

The FastPack™ PSA Immunoassay is a paramagnetic particle, chemiluminescence immunoassay intended for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The FastPack™ PSA Immunoassay is indicated as an aid in the management of patients with prostate cancer. The FastPack™ PSA Immunoassay is designed for use with the FastPack™ Analyzer System.

Device Story

FastPack™ PSA Immunoassay is a two-site chemiluminescence sandwich immunoassay performed on the FastPack™ Analyzer System. Input: 100 µL human serum sample. Process: Sample reacts with PSA antibody solution; streptavidin-coated paramagnetic particles added; sandwich complex binds to solid phase; unbound materials washed away; chemiluminogenic substrate added. Analyzer uses pressure pads to move reagents within a 2D plastic pack and magnets to hold particles during wash. Output: Chemiluminescent glow measured by photomultiplier tube (PMT). Used in clinical laboratory settings by trained personnel. Output provides quantitative PSA levels to assist physicians in prostate cancer management.

Clinical Evidence

Method comparison study (n=110) against Abbott IMx® PSA. Results: Deming regression y = 0.971x - 0.2367; r² = 0.984. Analytical sensitivity: 0.04 ng/mL. Precision (between-run) ranged from 9.4% to 13.1% CV. Spike recovery: 96-107%. Dilution recovery: 94-120%. No high-dose hook effect up to 500 ng/mL.

Technological Characteristics

Two-site sandwich chemiluminescence immunoassay. Components: FastPack™ (reagent pack), Sample Filler, Analyzer, Pressure/Power Supply. Solid phase: Streptavidin-coated paramagnetic particles. Substrate: ImmuGlow™ (Indoxyl-3-phosphate and lucigenin). Detection: Photomultiplier tube (PMT). Temperature control: Heated metal plates. Automated processing via pressure-driven reagent movement. Connectivity: Internal microcomputer for data reduction.

Indications for Use

Indicated for the in vitro quantitative determination of PSA in human serum as an aid in the management of patients with prostate cancer.

Regulatory Classification

Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Predicate Devices

• Abbott IMx® PSA (P910007) using Abbott IMx® Analyzer (K864319)

Submission Summary (Full Text)

{0}------------------------------------------------

994419

JUN 2 8 2000

Attachment 2 Page I of S

# 510(k) Summary

# FastPack™ PSA Immunoassay on the FastPack™ Analyzer System

This summary of 510(k) safety and effectivencss 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 92009 | | | | |
|----|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--|--|--|
| | | Telephone: | [phone] | | | |
| | | Fax: | [phone] | | | |
| | | Contact Person: | Vijay K. Mahant, Ph.D. | | | |
| | | Date Prepared: | June 22, 2000 | | | |
| 2. | Device name | Proprietary name: | FastPackTM PSA Immunoassay<br>on the FastPackTM Analyzer System | | | |
| | | Common name: | Chemiluminescence assay for the determination<br>of Prostate-Specific Antigen (PSA). | | | |
| | | | Photometer for clinical use. | | | |
| | | Classification Name: | Prostate-Specific Antigen (PSA) for Management<br>of Prostate Cancer | | | |
| | | | | | | |
| 3. | Predicate<br>device | Abbott IMx® PSA (P910007) using Abbott IMx® Analyzer (K864319) | | | | |
| 4. | Device<br>description | FastPackTM PSA Immunoassay Reagents | | | | |
| | | The FastPackTM PSA Immunoassay is a two-site chemiluminescence assay. | | | | |
| | | 1st incubation: 5 minutes at 37° C. Sample, control or calibrator [100<br>µL] and PSA antibody solution [100 µL] react to form a sandwich<br>complex. | | | | |

{1}------------------------------------------------

#### Qualigen, Incorporated

### 510(k) Summary (continued)

Attachment 2 Page 2 of 5

- 240 incubation; 5 minutes at 37° C. Streptavidin-coated paramagnetic ● particle solution is added to the reaction mixture. After the 5-minute incubation, the sandwich complex is bound to the solid phase via the interaction of biotin and streptavidin.
- Removal of unbound materials: The paramagnetic particles are washed . six times with wash buffer [0.2 mL/wash] to remove unbound materials.
- Substrate addition and detection: Chemiluminogenic substrate [175 . uL } is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack™ Analyzer System.

#### FastPack™ Analyzer System

The FastPack™ Analyzer System is a compact chemiluminuescent immuoassay system. The system consists of four components:

- FastPack™ (Reagent Pack) .
- FastPack™ Sample Filler ●
- FastPack™ Analyzer .
- Pressure/Power Supply ●

The FastPack™ is a small essentially two-dimensional plastic package that contains all the pre-measured reagents, in sealed chambers, necessary to perform the desired test. The pack label contains a barcode with all necessary information required by the analyzer to run the test.

The FastPack™ Sample Filler delivers an accurate quantified sample (100 UL) of sample, calibrator or control for testing.

The FastPack™ Analyzer is designed to receive the FastPack™ and to perform the necessary assay by automatically mixing and moving the sample and reagents within the pack. The sample and reagents are moved from one chamber to another by applying uniform pressure to the compartments by means of pressure pads extended from the analyzer. The analyzer uses a small magnet to hold the paramagnetic particles during the wash phase. During the entire run of the FastPack™, temperature control is achieved by heating metal plates that adjoin the FastPack™.

- ഗ് Intended use The FastPack™ PSA Immunoassay is a paramagnetic particle, chemiluminescence immunoassay intended for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The FastPack™ PSA Immunoassay is indicated as an aid in the management of patients with prostate cancer. The FastPack™ PSA Immunoassay is designed for use with the FastPack™ Analyzer System.

{2}------------------------------------------------

Attachment 2 Page 3 of 5

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The FastPack™ PSA Immunoassay on the FastPack™ Analyzer System is Comparison to 6. predicate substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the device currently marketed Abbott IMx® PSA on the Abbott IMx® Analyzer.

> The following tables compare the FastPack™ Immunoassay System for PSA with the Abbott IMx® System for PSA:

Similarines:

.

| • Assay Methodology: | Sandwich immunoassay |
|-----------------------|-------------------------------------------|
| • Sample Type: | Serum |
| • Storage Condition: | 2-8 °C |
| • Label | Alkaline Phosphatase |
| • Detector: | Photomultiplier Tube (PMT) |
| • Data Analysis | Internal data reduction via microcomputer |
| • Temperature Control | Required |
| • Test Processing | Automated |

| Comparison to | Differences: | | | | | |
|-----------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|--|--|--|
| predicate | Feature | FastPack™ PSA | Abbott IMx® PSA | | | |
| device<br>(continued) | Intended Use | For the in vitro<br>quantitative determination<br>of PSA in human serum.<br>It is indicated as an aid in<br>the management of<br>patients with prostate<br>cancer. | As an aid in the<br>management of prostate<br>cancer patients. | | | |
| | Sample Volume | 100 ul | 150 UL | | | |
| | Assay Range | 0 to 50 ng/mL | 0 to 100 ng/mL | | | |
| | Instrument<br>Required | FastPack™ Analyzer<br>System | Abbott IMx® Analyzer | | | |
| | Control Levels | 2 | 3 | | | |
| | Calibration<br>Levels | 5 | 6 | | | |
| | Capture<br>Antibody | Monoclonal | Polyclonal | | | |
| | Solid-phase | Streptavidin-coated<br>paramagnetic particles | Monoclonal Anti-PSA<br>coated microparticles | | | |
| | Substrate | ImmuGlowTN (Indoxyl -3-<br>phosphate and lucigenin) | 4-Methylumbelliferyl<br>Phosphate | | | |

{3}------------------------------------------------

# 510(k) Summary (continued)

# Qualigen, Incorporated

Attachment 2 Page 4 of 5

| Detection | Chemiluminescence | Fluorescence |
|---------------------|----------------------------------------------------------------------------------|-----------------------------------------|
| Calibration | Factory generated master<br>curve with daily two-level<br>calibration adjustment | Full calibration curve<br>every 4 weeks |
| Throughput | Single Sample | 24 Samples |
| Time to Result | 30 minutes | 40 minutes |
| Sample<br>Cartridge | All reagent included | Reagent pack and wash<br>separate |

# Performance Characteristics:

| Feature | FastPack™ PSA | Abbott IMx® PSA |
|----------------------------------------------|-------------------------------------------------|------------------|
| Precision | ng/mL PSA | ng/mL PSA |
| | Between Run | Intra-assay |
| | Low (0.75) 13.1% | Low (4.6) 3.5% |
| | Med (2.94) 11.2% | Med (15.6) 3.3% |
| | High (23.41) 9.4% | High (60.2) 3.1% |
| | Between Analyzer | Inter-assay |
| | Low (0.75) 6.2% | Low (4.6) 4.7% |
| | Med (2.94) 3.7% | Med (15.6) 4.5% |
| | High (23.41) 1.1% | High (60.2) 5.3% |
| | Between Reagent Lot | |
| | Low (0.75) 1.7% | |
| | Med (2.94) 5.0% | |
| | High (23.41) 1.4% | |
| Analytical<br>Sensitivity | 0.04 ng PSA/mL | 0.1 ng PSA/mL |
| Spike Recovery | 96 to 107% | 91 to 103% |
| Dilution<br>Recovery<br>Method<br>Comparison | 94 to 120% | Not reported |
| | versus Abbott IMx® PSA: | |
| | n = 110 | |
| | Range of values (Abbott): 0 to 51.6 ng PSA/mL | |
| | Range of values (FastPack): 0 to 57.0 ng PSA/mL | |
| | y = $0.971x - 0.2367$ (Deming) | |
| | $r^2$ = 0.984 (Spearman) | |
| | $s^2_{slope}$ = 0.000403 | |
| | $s^2_{intercept}$ = 0.111306 | |

{4}------------------------------------------------

#### Qualigen, Incorporated

# 510(k) Summary (continued)

Attachment 2
Page 5 of 5

| Interfering<br>Substances | | |
|---------------------------|---------------------------------------------|------------------------------------|
| Bilirubin | No interference up to:<br>49 mg/dL | No interference up to:<br>25 mg/dL |
| Hemoglobin | 600 mg/dL | 600 mg/dL |
| IgG | 1900 mg/dL | 250-2900 mg/dL |
| PAP | 1000 ng/mL | 1000 ng/mL |
| HSA | Interference found at 3 g/dL | 3-13 g/dL |
| Triglycerides | 3000 mg/dL | 3000 mg/dL |
| Cyclophosphamide | 700 µg/mL | 700 µg/mL |
| DES | 1 µg/mL | 2 µg/mL |
| Doxorubicin HCl | 16 µg/mL | 16 µg/mL |
| Methotrexate | 8 µg/mL | 30 µg/mL |
| Megestrol Acetate | 90 µg/mL | 90 µg/mL |
| Flutamide | 10 µg/mL | 10 µg/mL |
| Lupron | 100 µg/mL | 100 µg/mL |
| High Dose Hook<br>Effect | No high dose hook effect<br>up to 500 ng/mL | Not reported |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

### JUN 2 8 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Vijay Mahant, Ph.D. Vice President, Research and Development Qualigen, Inc. 2042 Corte del Nogal Carlsbad, California 92009

K994419 Re:

> Trade Name: Fastpack™ PSA Immunoassay Product Code: LTJ Regulatory Class: II JJO II Dated: April 25, 2000 Received: May 3, 2000

Dear Dr. Mahant:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{6}------------------------------------------------

#### Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin marketing your device to a legally marketed notification. The FD7 midnig of baseian.can vour device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and II you desire specific advices for your as ic devices), please contact the Office of Compliance at additionally 607.10 for m-rire diagnestions on the promotion and advertising of your device, [phone]. Truditionally, for quice at [phone]. Also, please note the regulation prease contact the Orneo or Complanes (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibilities and the end the results of [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

{7}------------------------------------------------

### Attachment 1

### Indications for Use Statement

| 510(k) Number | K994419 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | FastPack™ PSA Immunoassay and the FastPack™ Analyzer System |
| Indications for Use | The FastPack™ PSA Immunoassay is a paramagnetic particle,<br>chemiluminescence immunoassay for the in vitro quantitative<br>determination of prostate-specific antigen (PSA) in human serum. The<br>FastPack™ PSA Immunoassay is indicated as an aid in the management<br>of patients with prostate cancer. The FastPack™ PSA Immunoassay is<br>designed for use with the FastPack™ Analyzer System. |

#### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

### Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

: