FASTPACK TSH IMMUNOASSAY

K052301 · Qualigen, Inc. · JLW · Jan 4, 2006 · Clinical Chemistry

Device Facts

• Record ID: K052301
• Device Name: FASTPACK TSH IMMUNOASSAY
• Applicant: Qualigen, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Jan 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

The FastPack® TSH Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of Thyroid-Stimulating Hormone in human plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The FastPack® TSH is designed for use with the FastPack® System. The FastPack® TSH Calibrator is intended to calibrate the FastPack® System when used for the quantitative determination of TSH in human plasma. The FastPack® Controls are assayed quality control materials for the verification of the accuracy and precision of the FastPack® System when used for the quantitative determination of PSA in human serum and plasma, and TSH in human plasma.

Device Story

FastPack® TSH Immunoassay is a competitive chemiluminescence assay performed on the FastPack® System. Input: 100 µL human plasma sample. Process: Sample incubated with antibody solution (10 min, 37°C); transferred to paramagnetic particles (2 min, 37°C); unbound materials washed; chemiluminogenic substrate (ImmuGlow™) added. Output: Chemiluminescent glow measured by photomultiplier tube (PMT). System performs automated data reduction via internal microcomputer. Used in clinical settings for diagnostic testing. Results assist clinicians in diagnosing thyroid or pituitary disorders.

Clinical Evidence

Bench testing only. Method comparison study (n=93) against Abbott IMx Ultrasensitive hTSH II showed correlation (y = 0.91x + 1.26, r = 0.98). Analytical sensitivity 0.01 µIU/mL; functional sensitivity 0.13 µIU/mL. Precision evaluated across runs, analyzers, and reagent lots with %CVs ranging from 0.3% to 10.9%. Interference testing performed for bilirubin, hemoglobin, and triglycerides; specificity tested against LH, FSH, and hCG.

Technological Characteristics

Paramagnetic particle-based competitive chemiluminescence immunoassay. Uses alkaline phosphatase label and ImmuGlow™ (indoxyl-3-phosphate and lucigenin) substrate. Detection via photomultiplier tube. Automated processing at 37°C. Requires FastPack® System instrument. Storage 2-8°C. Software performs internal data reduction.

Indications for Use

Indicated for the quantitative determination of TSH in human plasma to aid in the diagnosis of thyroid or pituitary disorders.

Regulatory Classification

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Predicate Devices

• Abbott Laboratories IMx Ultrasensitive hTSH II (k942566)

Submission Summary (Full Text)

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K052301

JAN 4 2006

# 510(k) Summary

# FastPack® TSH Immunoassay on the FastPack® System

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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 name, address, contact | Qualigen, Incorporated<br>2042 Corte del Nogal<br>Carlsbad, CA 92011 |
|----|----------------------------------|------------------------------------------------------------------------|
| | | Telephone: [phone]<br>Fax: [phone] |
| | | Contact Person: Dorothy Peterson |
| | | Date Prepared: August 15, 2005 |
| 2. | Device name | Proprietary name: FastPack® TSH Immunoassay<br>on the FastPack® System |
| | | Common name: Chemiluminescence assay for the determination of TSH |
| | | Classification Name: Quantitative Determination of TSH in Human Plasma |
| 3. | Predicate device | Abbott Laboratories IMx Ultrasensitive hTSH II (K942566) |

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#### FastPack® TSH Immunoassay Reagents 4. Device description

The FastPack® TSH Immunoassay is a competitive chemiluminescence assay.

- . Primary incubation: Sample, calibrator, or control (100 uL) is added to the antibody solution (100 uL) to start the sequence. The reaction time is 10 minutes at 37° C.
- . Sccondary incubation: The initial reaction mixture (200 µL) is transferred to the magnetic particles and is incubated an additional 2 minutes at 37° C.
- . Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials.
- Substrate addition and detection: Chemiluminogenic substrate [140 . uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® System at 37° C.
- The FastPack® TSH Immunoassay is a paramagnetic particle immunoassay 5. Intended use intended for the in vitro quantitative determination of TSH in human plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The FastPack® TSH Immunoassay is designed for use with the FastPack® System.

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- 6. Comparison to The following tables compare the FastPack® Immunoassay System Predicate Device for TSH with the Abbott Laboratories Ultrasensitive TSH II method.
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| Feature | FastPack® System | Abbott IMx® System |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the quantitative<br>measurement of Thyroid-<br>Stimulating Hormone<br>(TSH) in human plasma.<br>The measurements of<br>thyroid stimulating<br>hormone (TSH) produced<br>by the anterior pituitary<br>are used in the diagnosis of<br>thyroid or pituitary<br>disorders. | For the quantitative<br>measurement of Thyroid-<br>Stimulating Hormone (TSH)<br>in human serum and<br>heparinized plasma. |
| Assay<br>Methodology: | Sandwich immunoassay | Sanwich immunoassay |
| Storage<br>Condition: | 2-8 °C | 2-8 °C |
| Data Analysis | Internal data reduction via<br>microcomputer | Internal data reduction via<br>microcomputer |
| Temperature<br>Control | Required | Required |
| Test Processing | Automated | Automated |
| Sample Type: | Plasma | Serum, Heparinized Plasma |
| Detector: | Photomultiplier Tube<br>(PMT) | Photomultiplier Tube (PMT) |
| Label | Alkaline Phosphatase | Alkaline Phosphatase |
| Sample Volume | 100 µL | 150 µL |
| Assay Range | 0 to 100 µIU/mL | 0 to 100 µIU/mL |
| Instrument<br>Required | FastPack® System | Abbott IMx® System |
| Control Levels | 2 | 3 |
| Antibody | Monoclonal/Monoclonal | Monoclonal/Polyclonal |
| Solid Phase | Paramagnetic particles | Latex Microparticles |
| Substrate | ImmuGlow™ (Indoxyl -3-<br>phosphate and lucigenin) | 4-Methylumbelliferyl<br>Phosphate |
| Detection | Chemiluminescence | Fluorescence |
| Calibration | Factory generated master<br>curve with a single level<br>calibration adjustment<br>every 14 days. | Full calibration curve (six<br>standards) with change in<br>reagents. |
| Throughput | Single Sample | Batch |
| Time to Result | 16 minutes | 45 minutes to first result |
| Reagents<br>Supplied as | Box of 50 disposable self<br>contained reagent packs | Reagent Pack for 100 test |

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## Qualigen, Incorporated

## Performance Characteristics:

| Feature | FastPack® TSH | | Abbott IMx® hTSH II | |
|---------------------------|------------------------|------|--------------------------------------------------------------------------------------------------------------------------------------------|------|
| Precision | | | | |
| | Mean<br>µIU/mL | %CV | Mean<br>µIU/mL | %CV |
| | Between Run | | Run to Run | |
| | 0.53 | 10.9 | 0.28 | 4.20 |
| | 1.54 | 7.4 | 6.10 | 3.42 |
| | 12.39 | 5.2 | | |
| | Between Analyzer | | Between Run | |
| | 0.53 | 2.2 | 0.28 | 3.44 |
| | 1.54 | 0.5 | 6.10 | 3.25 |
| | 12.39 | 1.1 | | |
| | Between Reagent Lot | | | |
| | 0.53 | 1.2 | | |
| | 1.54 | 0.3 | | |
| | 12.39 | 4.8 | | |
| Analytical<br>Sensitivity | 0.01 µIU/mL | | 0.02 µIU/mL | |
| Functional<br>Sensitivity | 0.13 µIU/mL | | 0.04 µIU/mL | |
| Method<br>Comparison | | | versus Abbott IMx Ultrasensitive hTSH II: | |
| | | | n = 93<br>Range of values (IMx): 0.00 to 75.00 µIU/mL<br>Range of values (FastPack): 0.03 to 64.25 µIU/mL<br>y = 0.91 x + 1.26<br>r = 0.98 | |
| Interfering<br>Substances | No interference up to: | | No interference up to: | |
| Bilirubin | 40 mg/dL | | 10 mg/dL | |
| Hemoglobin | 1000 mg/dL | | 1000 mg/dL | |
| Triglycerides | 1000 mg/dL | | 1200 mg/dL | |
| Specificity | 500 mIU/mL LH | n.d. | 1000 mIU/mL LH | n.d. |
| | 500 mIU/mL FSH | n.d. | 1000 mIU/mL FSH | n.d. |
| n.d. = not detected | 200,000 mIU/mL hCG | n.d. | 200,000 mIU/mL hCG | n.d. |

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## Qualigen, Incorporated

| Functional<br>Sensitivity | 0.13 µIU/mL | 0.04 µIU/mL |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Method<br>Comparison | versus Abbott IMx Ultrasensitive hTSH II:<br><br>n = 93<br>Range of values (IMx): 0.00 to 75.00 µIU/mL<br>Range of values (FastPack): 0.03 to 64.25 µIU/mL<br>y = 0.91 x + 1.26<br>r = 0.98 | |
| Interfering<br>Substances | No interference up to:<br> | No interference up to: |
| Bilirubin | 40 mg/dL | 10 mg/dL |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Triglycerides | 1000 mg/dL | 1200 mg/dL |
| Specificity | | |
| | 500 mIU/mL LH    n.d.<br>500 mIU/mL FSH    n.d.<br>200.000 mIU/mL hCG    n.d. | 1000 mIU/mL LH    n.d.<br>1000 mIU/mL FSH    n.d.<br>200.000 mIU/mL hCG    n.d |
| n.d. = not detected | | |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.

### JAN 4 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Dorothy Deinzer Peterson Vice President Ouality Assurance and Regulatory Affairs Qualigen Incorporated 2042 Corte del Nogal Carlsbad, CA 92011

Re: k052301

> Trade/Device Name: FastPack® TSH Immunoassay FastPack® TSH Calibrator FastPack® TSH Controls

Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system

Regulatory Class: Class II Product Code: JLW, JJX, JIT

Dated: December 6, 2005

Received: December 14, 2005

Dear Ms. Peterson:

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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 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" (21CFR 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 vours.

Alberto Guts

Alberto Gutierrez, 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 Statement

| 510(k) Number | K052301 |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | FastPack® TSH Immunoassay, FastPack® TSH Calibrator, FastPack® Controls |
| Indications for Use | The FastPack® TSH Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the <i>in vitro</i> quantitative determination of Thyroid-Stimulating Hormone in human plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The FastPack® TSH is designed for use with the FastPack® System.<br>The FastPack® TSH Calibrator is intended to calibrate the FastPack® System when used for the quantitative determination of TSH in human plasma.<br>The FastPack ® Controls are assayed quality control materials for the verification of the accuracy and precision of the FastPack® System when used for the quantitative determination of PSA in human serum and plasma, and TSH in human plasma. |
| Prescription Use<br>(Per 21 CFR 801 Subpart D) | X |
| | AND/OR Over-The-Counter Use<br>(21 CFR 807 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Ann Chappe

Division Sign-Off

Office of In Vitro Diagnostic Device

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