← Product Code [CDZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ) · K021972 # FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY (K021972) _Qualigen, Inc. · CDZ · Aug 21, 2002 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K021972 ## Device Facts - **Applicant:** Qualigen, Inc. - **Product Code:** [CDZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ.md) - **Decision Date:** Aug 21, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1680 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Intended Use The FastPack® Total Testosterone Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of testosterone in human serum. The FastPack® Total Testosterone 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 conditions involving excess or deficiency of this androgen. ## Device Story FastPack® Total Testosterone Immunoassay is a competitive chemiluminescence immunoassay performed on the FastPack® Analyzer System. Input: 100 µL human serum sample. Process: Sample incubated with antibody solution; mixture transferred to paramagnetic particles coated with testosterone; competitive binding occurs; unbound materials washed away; chemiluminogenic substrate added. Output: Chemiluminescent glow measured by photomultiplier tube (PMT) in the analyzer. Used in clinical laboratory settings by trained personnel. System provides automated data reduction via internal microcomputer. Results assist clinicians in diagnosing and managing androgen-related conditions. Benefits include automated processing and faster turnaround time (12 minutes) compared to traditional manual radioimmunoassays. ## Clinical Evidence Bench testing only. Performance characteristics include: analytical sensitivity of 0.13 ng/mL; intra-assay precision (3.8% to 10.3% CV); spike recovery (94-110%); dilution recovery (99-132%). Method comparison against DPC Coat-A-Count (n=144) yielded y = 1.065x - 0.004 and r = 0.930. Interference testing performed for bilirubin, hemoglobin, and triglycerides. Specificity evaluated against various steroids (e.g., 5-α-DHT, androstenedione, estradiol) showing low cross-reactivity. ## Technological Characteristics Competitive chemiluminescence immunoassay. Uses paramagnetic particles coated with testosterone-3-CMO. Detection via alkaline phosphatase label and ImmuGlow™ substrate (indoxyl-3-phosphate and lucigenin). Automated processing on FastPack® Analyzer System using a photomultiplier tube. Requires 37°C temperature control. Reagents supplied in disposable self-contained packs. Storage at 2-8°C. ## Regulatory 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 - Diagnostic Products Corporation's Coat-A-Count Total Testosterone RIA Kit ([K964889](/device/K964889.md)) ## Related Devices - [K223405](/device/K223405.md) — Access Testosterone · Beckman Coulter, Inc. · Jan 13, 2023 - [K101388](/device/K101388.md) — FASTPACK TESTO IMMUNOASSAY · Qualigen, Inc. · Feb 18, 2011 - [K032881](/device/K032881.md) — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE · Diagnostic Products Corp. · Oct 10, 2003 - [K041866](/device/K041866.md) — ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) · Axis-Shield Diagnostics, Ltd. · Sep 29, 2004 ## Submission Summary (Full Text) {0}------------------------------------------------ K021972 # AUG 2 1 2002 to the may be and the first the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the state # 510(k) Summary ## FastPack® Total Testosterone 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, contact | Qualigen, Incorporated<br>2042 Corte del Nogal<br>Carlsbad, CA 92009 | |----|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Telephone:<br>(760) 918-9165<br>Fax:<br>(760) 918-9127 | | | | Contact Person:<br>Dorothy Deinzer | | | | Date Prepared:<br>June 14, 2002 | | 2. | Device name | Proprietary name:<br>FastPack® Total Testosterone Immunoassay<br>on the FastPack® Analyzer System | | | | Common name:<br>Chemiluminescense assay for the determination of<br>Total Testosterone | | | | Classification Name:<br>Quantitative Determination of Total Testosterone<br>in Human Serum | | 3. | Predicate device | Diagnostic Products Corporation's Coat-A-Count Total Testosterone RIA<br>Kit (K964889) | | 4. | Device description | FastPack® Total Testosterone Immunoassay Reagents<br>The FastPack® Total Testosterone Immunoassay is a competitive<br>chemiluminescense 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 5 minutes 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. The FastPack® Total Testosterone Immunoassay is a paramagnetic particle 5. Intended use immunossay intended for the in vitro quantitative determination of total testosterone in human serum. The FastPack® Total Testosterone 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 conditions involving excess or deficiency of this androgen - ર્વ Comparison to The following tables compare the FastPack™ Immunoassay System Predicate Device for Testosterone with the DPC Coat-A-Count@ Total Testosterone: | Feature | FastPack™ System | DPC Coat-A-Count | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For the <i>in vitro</i><br>quantitative determination<br>of testosterone in human<br>serum. It is intended<br>strictly for <i>in vitro</i><br>diagnostic use as an aid<br>in the diagnosis and<br>management of<br>conditions involving<br>excess or deficiency of<br>this androgen. | For the quantitative<br>measurement of testosterone in<br>unextracted serum or<br>heparinized plasma. Coupled<br>with an acid hydrolysis<br>procedure, it is also suitable<br>for assaying urine samples. It<br>is intended strictly for <i>in vitro</i><br>diagnostic use as an aid in the<br>diagnosis and management of<br>conditions involving excess or<br>deficiency of this androgen. | | Assay<br>Methodology: | Competitive immunoassay | Competitive immunoassay | | Storage<br>Condition: | 2-8 °C | 2-8 °C | {2}------------------------------------------------ | Data Analysis | Internal data reduction via<br>microcomputer | Manually Graph Logit-Log | |-------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Temperature<br>Control | Required | Required | | Test Processing | Automated | Manual | | Sample Type: | Serum | Serum, Heparinized Plasma,<br>Acid Hydrolyzed Urine | | Detector: | Photomultiplier Tube<br>(PMT) | Gamma Counter | | Label | Alkaline Phosphatase | 125I | | Sample Volume | 100 µL | 50 µL | | Assay Range | 0.07 to 16 ng/mL | 4 to 1600 ng/dL | | Instrument<br>Required | FastPack™ Analyzer<br>System | gamma counter<br>vortex mixer | | Control Levels | 2(not supplied) | 3 (not supplied) | | Antibody | Monoclonal | Polyclonal | | Competing<br>component | Testosterone-3-CMO<br>covalently coupled to<br>paramagnetic particles | 125I iodinated testosterone | | Solid Phase | paramagnetic particles | Polypropylene tubes coated<br>with antibodies to testosterone | | Substrate | ImmuGlow™ (Indoxyl -3-<br>phosphate and lucigenin) | None | | Detection | Chemiluminescence | Radiometric | | Calibration | Factory generated master<br>curve with single-level<br>calibration adjustment<br>every 14 days. | Full calibration curve every<br>test run using 6 standards. | | Throughput | Single Sample | Batch of tubes | | Time to Result | 12 minutes | 180 minutes | | Reagents<br>Supplied as | Box of 50 disposable self<br>contained reagent packs | 100 (200 or 500) coated tubes,<br>one (two or five) vial(s) of 125I<br>testosterone, 6 vials of<br>calibrator | #### Performance Characteristics: | Feature | FastPack™ Testosterone | | DPC Coat-A-count | |-----------|------------------------|-----------------------|----------------------------------------------------------------------------| | Precision | | | | | | | Mean<br>ng/mL | Intra-assay | | | Between Run | Low 0.14<br>High 7.12 | Reported as a graph<br>4% CV to 7.5%CV over the<br>1ng/mL to 16ng/mL range | | | | 0.06 SD<br>10.3%C.V. | | | | Between Analyzer | Low 0.14<br>High 7.12 | Inter-assay | | | | 0.03 SD<br>3.8%C.V. | Level Mean<br>ng/mL<br>Low 0.76 .09 SD | {3}------------------------------------------------ | | | High | 6.7 | 6.0% C.V. | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|----------|---------------------------------------------------| | | Between Reagent Lot | | | | | | Low | 0.14 | 0.01 SD | | | | High | 7.12 | 0.1%C.V. | | | Analytical<br>Sensitivity | 0.13 ng Testosterone/mL | | | 0.04 ng testosterone/mL<br>(4 ng testosterone/dL) | | Spike Recovery | 94 -110% | | | 93 to 103% | | Dilution<br>Recovery | 99 - 132% | | | 96% to 108% | | Method<br>Comparison | versus DPC Coat-A-Count® Total Testosterone:<br>n = 144<br>Range of values (DPC): 0 to 16.9 ng Testosterone/mL<br>Range of values (Fastpack): 0 to 18.4 ng<br>Testosterone/mL<br>y = 1.065x - 0.004<br>r = 0.930 | | | | | Interfering<br>Substances | No interference up to:<br>Bilirubin<br>40 mg/dL<br>Hemoglobin<br>1000 mg/dL<br>Triglycerides<br>1000 mg/dL | No interference up to:<br>25 mg/dL<br>600 mg/dL<br>3000 mg/dL | | | | Specificity | | | | | |-----------------|----------------------|------------------------|----------------------|------------------------| | | FastPack® System | | DPC Coat-A-Count | | | Material Tested | Test Levels<br>ng/mL | % Cross-<br>reactivity | Test Levels<br>ng/mL | % Cross-<br>reactivity | | 5-α-DHT | 50 | 3.16 | 50 | 3.3 | | Androstenedione | 1,000 | 1.15 | 1,000 | 0.5 | | Androsterone | 100,000 | 0.01 | 100,000 | 0.004 | | Estradiol | 1,000 | 0.006 | 1,000 | 0.02 | | Danazol | 1,000 | 0.002 | 200 | 0.09 | | Cortisol | 8,000 | 0.001 | 8,000 | 0.005 | | DHEA | 10,000 | 0.003 | 10,000 | 0.002 | | Oxymetholone | 100 | 0.02 | Not Reported | Not<br>Reported | {4}------------------------------------------------ .. _.. .. .. # 510(k) Summary (continued) | Estrone | 500 | 0.003 | 500 | 1.01 | |--------------------|-------|-------|-------|-------| | Corticosterone | 5,000 | 0.003 | 5,000 | 0.002 | | Methyltestosterone | 100 | 0.03 | 30 | ND | | 11-Deoxycortisol | 1,000 | ND | 1,000 | ND | | Progesterone | 1,000 | 0.01 | 1,000 | ND | | 19-Nor Testo | 1,000 | 2.05 | 100 | 2220 | | 19-Nor Testo | 500 | 2.07 | 500 | 22 | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird or eagle with three lines representing its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 AUG 2 1 2002 Ms. Dorothy Deinzer Director Quality and Regulatory Affairs Qualigen, Inc. 2042 Corte Del Nogal Carlsbad, CA 92009 Re: k021972 > Trade/Device Name: FastPack® Total Testosterone Immunoassay Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone test system Regulatory Class: Class I Product Code: CDZ Dated: June 14, 2002 Received: June 17, 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 reguirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {6}------------------------------------------------ Page 2 - 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.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 {7}------------------------------------------------ ### Attachment 4 | 510(k) Number | K021972 | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | FastPack® Total Testosterone Immunoassay | | Indications for Use | The FastPack® Total Testosterone Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of testosterone in human serum. The FastPack® Total Testosterone 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 conditions involving excess or deficiency of this androgen. | Can Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K021972 #### 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K021972](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K021972) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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