(65 days)
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.
The FastPack® Total Testosterone Immunoassay is a competitive chemiluminescense assay.
• Primary incubation: Sample, calibrator, or control (100 µL) is added to the antibody solution (100 µL) to start the sequence. The reaction time is 5 minutes at 37° C
• 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 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.
The Qualigen FastPack® Total Testosterone Immunoassay on the FastPack® Analyzer System (K021972) is a chemiluminescence immunoassay for the quantitative determination of total testosterone in human serum. The device performance was evaluated by comparing it to the Diagnostic Products Corporation's Coat-A-Count Total Testosterone RIA Kit (K964889).
Here's an overview of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission does not explicitly state pre-defined acceptance criteria in a table format, but rather presents performance characteristics and compares them to the predicate device. For analytical performance, the "Predicate Device" column can be interpreted as a benchmark to demonstrate substantial equivalence.
| Feature | Predicate Device (DPC Coat-A-Count) | Qualigen FastPack® Total Testosterone Immunoassay |
|---|---|---|
| Precision | ||
| Intra-assay | Reported as a graph (4% CV to 7.5% CV over 1-16 ng/mL) | Between Run: Low 0.14 ng/mL, 0.06 SD, 10.3% CV; High 7.12 ng/mL |
| Inter-assay | Level Mean: Low 0.76 ng/mL, 0.09 SD; High 6.7 ng/mL, 6.0% CV | Between Analyzer: Low 0.14 ng/mL, 0.03 SD, 3.8% CV; High 7.12 ng/mL |
| Between Reagent Lot: Low 0.14 ng/mL, 0.01 SD; High 7.12 ng/mL, 0.1% CV | ||
| Analytical Sensitivity | 0.04 ng testosterone/mL (4 ng testosterone/dL) | 0.13 ng Testosterone/mL |
| Spike Recovery | 93 to 103% | 94 - 110% |
| Dilution Recovery | 96% to 108% | 99 - 132% |
| Method Comparison | (n=144, Range: 0 to 16.9 ng/mL) -> Reference Method | y = 1.065x - 0.004, r = 0.930 (Range: 0 to 18.4 ng/mL) |
| Interfering Substances | Bilirubin: No interference up to 25 mg/dL; Hemoglobin: No interference up to 600 mg/dL; Triglycerides: No interference up to 3000 mg/dL | Bilirubin: No interference up to 40 mg/dL; Hemoglobin: No interference up to 1000 mg/dL; Triglycerides: No interference up to 1000 mg/dL |
| Specificity | Similar cross-reactivity profiles to the predicate, with some differences (e.g., 19-Nor Testo) | Various materials tested (e.g., 5-α-DHT, Androstenedione, Estradiol) with reported % Cross-reactivity. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Method Comparison (Test Set): n = 144
- Data Provenance: Not explicitly stated (e.g., country of origin). The submission does not specify if the data was retrospective or prospective, but clinical studies for such IVD devices are typically prospective or involve retrospective analysis of collected clinical samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the 510(k) summary. For immunoassay devices, ground truth is typically established by comparative analysis with a well-characterized reference or predicate method, rather than expert interpretation of results. The predicate "DPC Coat-A-Count® Total Testosterone" serves as the reference method here.
4. Adjudication Method for the Test Set:
Not applicable. For quantitative diagnostic assays, ground truth is established by the results of a reference method, not by expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC study was not done. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging AI) where multiple human readers assess cases, and their performance is compared with and without AI assistance. This device is a quantitative immunoassay system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the performance characteristics (Precision, Analytical Sensitivity, Spike Recovery, Dilution Recovery, Method Comparison, Interfering Substances, Specificity) are all standalone performance metrics of the FastPack® Total Testosterone Immunoassay system itself. The system provides quantitative results without human interpretation in the loop.
7. The Type of Ground Truth Used:
The ground truth for the method comparison study was established by comparing the results of the FastPack® Total Testosterone Immunoassay with the DPC Coat-A-Count® Total Testosterone RIA Kit (K964889), which served as the predicate/reference method.
8. The Sample Size for the Training Set:
The 510(k) summary does not explicitly state a "training set" sample size in the context of machine learning. For traditional immunoassay development, the "training" aspect would relate to the assay's development and optimization, which isn't typically quantified with a sample size in the same way as a machine learning model. The provided data focuses on the validation of the final assay.
9. How the Ground Truth for the Training Set Was Established:
Not applicable in the context of a machine learning "training set". For the development and optimization of an immunoassay, the "ground truth" (or target values) for calibrators and controls would be established through a rigorous process of reference material characterization, often involving comparison to established reference methods or orthogonal techniques.
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AUG 2 1 2002
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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. | Submittername, address, contact | Qualigen, Incorporated2042 Corte del NogalCarlsbad, CA 92009 |
|---|---|---|
| Telephone:(760) 918-9165Fax:(760) 918-9127 | ||
| Contact Person:Dorothy Deinzer | ||
| Date Prepared:June 14, 2002 | ||
| 2. | Device name | Proprietary name:FastPack® Total Testosterone Immunoassayon the FastPack® Analyzer System |
| Common name:Chemiluminescense assay for the determination ofTotal Testosterone | ||
| Classification Name:Quantitative Determination of Total Testosteronein Human Serum | ||
| 3. | Predicate device | Diagnostic Products Corporation's Coat-A-Count Total Testosterone RIAKit (K964889) |
| 4. | Device description | FastPack® Total Testosterone Immunoassay ReagentsThe FastPack® Total Testosterone Immunoassay is a competitivechemiluminescense assay. |
| • Primary incubation: Sample, calibrator, or control (100 µL) is addedto the antibody solution (100 µL) to start the sequence. The reactiontime is 5 minutes at 37° C |
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- . 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 in vitroquantitative determinationof testosterone in humanserum. It is intendedstrictly for in vitrodiagnostic use as an aidin the diagnosis andmanagement ofconditions involvingexcess or deficiency ofthis androgen. | For the quantitativemeasurement of testosterone inunextracted serum orheparinized plasma. Coupledwith an acid hydrolysisprocedure, it is also suitablefor assaying urine samples. Itis intended strictly for in vitrodiagnostic use as an aid in thediagnosis and management ofconditions involving excess ordeficiency of this androgen. |
| AssayMethodology: | Competitive immunoassay | Competitive immunoassay |
| StorageCondition: | 2-8 °C | 2-8 °C |
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| Data Analysis | Internal data reduction viamicrocomputer | Manually Graph Logit-Log |
|---|---|---|
| TemperatureControl | Required | Required |
| Test Processing | Automated | Manual |
| Sample Type: | Serum | Serum, Heparinized Plasma,Acid Hydrolyzed Urine |
| Detector: | Photomultiplier Tube(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 |
| InstrumentRequired | FastPack™ AnalyzerSystem | gamma countervortex mixer |
| Control Levels | 2(not supplied) | 3 (not supplied) |
| Antibody | Monoclonal | Polyclonal |
| Competingcomponent | Testosterone-3-CMOcovalently coupled toparamagnetic particles | 125I iodinated testosterone |
| Solid Phase | paramagnetic particles | Polypropylene tubes coatedwith antibodies to testosterone |
| Substrate | ImmuGlow™ (Indoxyl -3-phosphate and lucigenin) | None |
| Detection | Chemiluminescence | Radiometric |
| Calibration | Factory generated mastercurve with single-levelcalibration adjustmentevery 14 days. | Full calibration curve everytest run using 6 standards. |
| Throughput | Single Sample | Batch of tubes |
| Time to Result | 12 minutes | 180 minutes |
| ReagentsSupplied as | Box of 50 disposable selfcontained reagent packs | 100 (200 or 500) coated tubes,one (two or five) vial(s) of 125Itestosterone, 6 vials ofcalibrator |
Performance Characteristics:
| Feature | FastPack™ Testosterone | DPC Coat-A-count | |
|---|---|---|---|
| Precision | |||
| Meanng/mL | Intra-assay | ||
| Between Run | Low 0.14High 7.12 | Reported as a graph4% CV to 7.5%CV over the1ng/mL to 16ng/mL range | |
| 0.06 SD10.3%C.V. | |||
| Between Analyzer | Low 0.14High 7.12 | Inter-assay | |
| 0.03 SD3.8%C.V. | Level Meanng/mLLow 0.76 .09 SD |
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| High | 6.7 | 6.0% C.V. | ||
|---|---|---|---|---|
| Between Reagent Lot | ||||
| Low | 0.14 | 0.01 SD | ||
| High | 7.12 | 0.1%C.V. | ||
| AnalyticalSensitivity | 0.13 ng Testosterone/mL | 0.04 ng testosterone/mL(4 ng testosterone/dL) | ||
| Spike Recovery | 94 -110% | 93 to 103% | ||
| DilutionRecovery | 99 - 132% | 96% to 108% | ||
| MethodComparison | versus DPC Coat-A-Count® Total Testosterone:n = 144Range of values (DPC): 0 to 16.9 ng Testosterone/mLRange of values (Fastpack): 0 to 18.4 ngTestosterone/mLy = 1.065x - 0.004r = 0.930 | |||
| InterferingSubstances | No interference up to:Bilirubin40 mg/dLHemoglobin1000 mg/dLTriglycerides1000 mg/dL | No interference up to:25 mg/dL600 mg/dL3000 mg/dL |
| Specificity | ||||
|---|---|---|---|---|
| FastPack® System | DPC Coat-A-Count | |||
| Material Tested | Test Levelsng/mL | % Cross-reactivity | Test Levelsng/mL | % Cross-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 | NotReported |
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.. _.. .. ..
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 |
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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.
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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
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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
§ 862.1680 Testosterone test system.
(a)
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.(b)
Classification. Class I.