FASTPACK FREE T4 IMMUNOASSAY

{0}------------------------------------------------ 510(k) Summary k030329 ## FastPack® Free T4 Immunoassay on the FastPack® Analyzer System ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 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 92009 | | | |----|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|--| | | | Telephone:<br>Fax: | (760) 918-9165<br>(760) 918-9127 | | | | | Contact Person: | Dorothy Deinzer | | | | | Date Prepared: | January 28, 2003 | | | 2. | Device name | Proprietary name: | FastPack® Free T4 Immunoassay<br>on the FastPack® Analyzer System | | | | | Common name: | Chemiluminescense assay for the determination of<br>Free T4 | | | | | Classification Name: | Quantitative Determination of Free T4 in Human<br>Serum | | | 3. | Predicate<br>device | Abbott Laboratories IMx Free T4 (K902834) | | | | 4. | Device<br>description | FastPack® Free T4 Immunoassay Reagents | | | | | | The FastPack® Free T4 Immunoassay is a competitive chemiluminescense<br>assay. | | | | | | ● Primary incubation: Sample, calibrator, or control (100 µL) is added<br>to the antibody solution (100 µL) to start the sequence. The reaction<br>time is 10 seconds at 37° C. | | | {1}------------------------------------------------ - . Secondary incubation: The initial reaction mixture (200 uL) is transferred to the magnetic particles with bound testosterone and competition between the sample testosterone and the beads continues for an additional 2.5 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® Analyzer System at 37° C. - Intended use న. The FastPack® Free Ta Immunoassay is a paramagnetic particle immunoassay intended for the in vitro quantitative determination of Free T4 in human serum. The FastPack® Free T4 Immunoassay is designed for use with the FastPack® Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of thyroid dysfunction. - 6. Comparison to The following tables compare the FastPack® Immunoassay System Predicate Device for Free T4 with the Abbott Laboratories Free T4 method. | Feature | FastPack® System | Abbott IMx® System | |------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Intended Use | For the quantitative<br>measurement of free<br>thyroxine in human serum. | For the quantitative<br>measurement of free thyroxine<br>(FT4) in human serum and<br>heparinized plasma. | | Assay<br>Methodology: | Competitive immunoassay | Competitive 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: | Serum | Serum, Heparinized Plasma | | Detector: | Photomultiplier Tube<br>(PMT) | Photomultiplier Tube (PMT) | | Label | Alkaline Phosphatase | Alkaline Phosphatase | {2}------------------------------------------------ | Sample Volume | 100 µL | 150 µL | |-------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | Assay Range | 0.4 to 6 ng/dL | 0.4 to 6 ng/dL | | Instrument<br>Required | FastPack® Analyzer<br>System | Abbott IMx® System | | Control Levels | 2(not supplied) | 3 | | Antibody | Monoclonal | Polyclonal | | Competing<br>component | T3 covalently coupled to<br>paramagnetic particles | T3-Alkaline Phosphatase<br>Conjugate | | Solid Phase | Paramagnetic particles | Latex Microparticles | | Substrate | ImmuGlow™ (Indoxyl -3-<br>phosphate and lucigenin) | 4-Methylumbelliferyl<br>Phosphate | | Detection | Chemiluminescense | Fluorescence | | Calibration | Factory generated master<br>curve with 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 | 7 minutes | 45 minutes to first result | | Reagents<br>Supplied as | Box of 50 disposable self<br>contained reagent packs | Free T4 Reagent Pack for 100<br>test, 6 vials of calibrator | ## Performance Characteristics: | Feature | | FastPack® Free T4 | | | Abbott IMx® Free T4 | | |---------------------------|---------------------------------------------------|-------------------|------|-------------|---------------------|------| | Precision | | Mean<br>ng/dL | %CV | | Mean<br>ng/dL | %CV | | | Between Run | | | Run to Run | | | | | 1 | 1.43 | 7.4 | 1 | 1.18 | 4.47 | | | 2 | 3.51 | 6.2 | 2 | 3.23 | 5.59 | | | Between Analyzer | | | Between Run | | | | | 1 | 1.43 | 2.8 | 1 | 1.18 | 3.80 | | | 2 | 3.51 | 1.8 | 2 | 3.23 | 4.79 | | | Between Reagent Lot | | | | | | | | 1 | 1.43 | 11.1 | | | | | | 2 | 3.51 | 4.8 | | | | | Analytical<br>Sensitivity | | 0.4 ng T4/dL | | | 0.4 ng T4/dL | | | Method<br>Comparison | versus Abbott IMx Free T4: | | | | | | | | n = 131 | | | | | | | | Range of values (IMx): 0.61 to 5.52 ng T4/dL | | | | | | | | Range of values (FastPack): 0.52 to 5.93 ng T4/dL | | | | | | | | y = 1.07x - 0.17 | | | | | | | | r = 0.95 | | | | | | {3}------------------------------------------------ ## Qualigen, Incorporated | Interfering<br>Substances | No interference up to: | No interference up to: | |---------------------------|------------------------|------------------------| | Bilirubin | 40 mg/dL | 20 mg/dL | | Hemoglobin | 1000 mg/dL | 1000 mg/dL | | Triglycerides | 1000 mg/dL | 1200 mg/dL | | Specificity | L-T3<br>≤ 0.9% | L-T3<br>≤ 0.5% | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. Food and Drug Administration 2098 Gaither Road Rockville MC 20850 Ms. Dorothy Deinzer Vice President Quality and Regulatory Affairs Qualigen, Inc. 2042 Corte Del Nogal Carlsbad, CA 92009 'JUL 0 3 2003 k030329 Re: Trade/Device Name: FastPack® Free T4 Immunoassay FastPack® Testo/Free T4 Calibrator Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system : Regulatory Class: Class II Product Code: CEC; JIX Dated: May 23, 2003 Received: May 28, 2003 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 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). {5}------------------------------------------------ #### Page 2 -- 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Steven Sutman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Page 1 of 2 # Attachment 4 # Indications for Use Statement | 510(k) Number | K030329 | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | FastPack ^® Free T4 Immunoassay | | Indications for Use | The FastPack ^® Free T4 Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the <i>in vitro</i> quantitative determination of free thyroxine (FT4) in human serum. The FastPack ^® Free T4 Immunoassay is designed for use with the FastPack ^® Analyzer System. It is intended strictly for <i>in vitro</i> diagnostic use as an aid in the diagnosis and management of thyroid dysfunction. | Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety | 510(k) | K030329 | |--------|---------| |--------|---------| PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ {7}------------------------------------------------ Page 2 of 2 # Indications for Use Statement | 510(k) Number | K030329 | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | FastPack® Testo/Free T4 Calibrator | | Indications for Use | The FastPack® Testo/Free T4 Calibrator is intended to calibrate the FastPack® Analyzer system when used for the quantitative determination of Total Testosterone or Free T4 in human serum | Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K030329 ### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED ## Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________