(65 days)
Not Found
No
The description details a standard immunoassay process and mentions no computational or algorithmic components that would suggest the use of AI or ML.
No
The device is an in vitro diagnostic (IVD) immunoassay designed for quantitative determination of testosterone levels, which aids in diagnosis and management, but does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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."
No
The device is an in vitro diagnostic immunoassay kit that involves chemical reactions and paramagnetic particles, requiring a physical analyzer system (FastPack® Analyzer System) for measurement. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states: "The FastPack® Total Testosterone Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of testosterone in human serum." The phrase "in vitro" is the key indicator of an IVD. It also states it is "intended strictly for in vitro diagnostic use".
- Device Description: The description details a laboratory-based assay process involving chemical reactions and measurements of a biological sample (human serum). This is characteristic of an IVD.
- Performance Studies: The performance studies compare the device to a predicate device (DPC Coat-A-Count® Total Testosterone RIA Kit), which is also an IVD. The metrics reported (analytical sensitivity, spike recovery, dilution recovery, specificity) are typical performance characteristics evaluated for IVDs.
- Predicate Device: The mention of a predicate device with a K number (K964889) indicates that this device is being compared to a previously cleared IVD by a regulatory body (likely the FDA in the US).
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
CDZ
Device Description
FastPack® Total Testosterone Immunoassay Reagents The FastPack® Total Testosterone Immunoassay is a competitive chemiluminescence 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. 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Method Comparison versus DPC Coat-A-Count® Total Testosterone: n = 144 Range of values (DPC): 0 to 16.9 ng Testosterone/mL Range of values (Fastpack): 0 to 18.4 ng Testosterone/mL y = 1.065x - 0.004 r = 0.930.
Key Metrics
Precision:
Intra-assay: Reported as a graph 4% CV to 7.5% CV over the 1ng/mL to 16ng/mL range for DPC Coat-A-count.
Between Run (FastPack®): Low 0.14 ng/mL, High 7.12 ng/mL. 0.06 SD, 10.3% C.V.
Between Analyzer (FastPack®): Low 0.14 ng/mL, High 7.12 ng/mL. 0.03 SD, 3.8% C.V.
Inter-assay (DPC Coat-A-count): Low 0.76 ng/mL, 0.09 SD. High 6.7 ng/mL, 6.0% C.V.
Between Reagent Lot (FastPack®): Low 0.14 ng/mL, 0.01 SD. High 7.12 ng/mL, 0.1% C.V.
Analytical Sensitivity:
FastPack® Testosterone: 0.13 ng Testosterone/mL
DPC Coat-A-count: 0.04 ng testosterone/mL (4 ng testosterone/dL)
Spike Recovery:
FastPack® Testosterone: 94 -110%
DPC Coat-A-count: 93 to 103%
Dilution Recovery:
FastPack® Testosterone: 99 - 132%
DPC Coat-A-count: 96% to 108%
Interfering Substances:
No interference up to: Bilirubin 40 mg/dL, Hemoglobin 1000 mg/dL, Triglycerides 1000 mg/dL for FastPack®.
No interference up to: 25 mg/dL, 600 mg/dL, 3000 mg/dL for DPC Coat-A-count.
Specificity (Cross-reactivity %):
5-α-DHT: FastPack® 3.16%, DPC 3.3%
Androstenedione: FastPack® 1.15%, DPC 0.5%
Androsterone: FastPack® 0.01%, DPC 0.004%
Estradiol: FastPack® 0.006%, DPC 0.02%
Danazol: FastPack® 0.002%, DPC 0.09%
Cortisol: FastPack® 0.001%, DPC 0.005%
DHEA: FastPack® 0.003%, DPC 0.002%
Oxymetholone: FastPack® 0.02%, DPC Not Reported
Estrone: FastPack® 0.003%, DPC 1.01%
Corticosterone: FastPack® 0.003%, DPC 0.002%
Methyltestosterone: FastPack® 0.03%, DPC ND
11-Deoxycortisol: FastPack® ND, DPC ND
Progesterone: FastPack® 0.01%, DPC ND
19-Nor Testo: FastPack® 2.05% (Test Levels 1,000), 2.07% (Test Levels 500) ; DPC 2220% (Test Levels 100), 22% (Test Levels 500)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
name, address, contact | Qualigen, Incorporated
2042 Corte del Nogal
Carlsbad, CA 92009 |
|----|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Telephone:
(760) 918-9165
Fax:
(760) 918-9127 |
| | | Contact Person:
Dorothy Deinzer |
| | | Date Prepared:
June 14, 2002 |
| 2. | Device name | Proprietary name:
FastPack® Total Testosterone Immunoassay
on the FastPack® Analyzer System |
| | | Common name:
Chemiluminescense assay for the determination of
Total Testosterone |
| | | Classification Name:
Quantitative Determination of Total Testosterone
in Human Serum |
| 3. | Predicate device | Diagnostic Products Corporation's Coat-A-Count Total Testosterone RIA
Kit (K964889) |
| 4. | Device description | FastPack® Total Testosterone Immunoassay Reagents
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 |
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 in vitro | |
| quantitative determination | ||
| of testosterone in human | ||
| serum. 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. | For the quantitative | |
| measurement of testosterone in | ||
| unextracted serum or | ||
| heparinized plasma. Coupled | ||
| with an acid hydrolysis | ||
| procedure, it is also suitable | ||
| for assaying urine samples. 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. | ||
| Assay | ||
| Methodology: | Competitive immunoassay | Competitive immunoassay |
| Storage | ||
| Condition: | 2-8 °C | 2-8 °C |
2
| Data Analysis | Internal data reduction via
microcomputer | Manually Graph Logit-Log |
|-------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Temperature
Control | 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 |
| Instrument
Required | FastPack™ Analyzer
System | gamma counter
vortex mixer |
| Control Levels | 2(not supplied) | 3 (not supplied) |
| Antibody | Monoclonal | Polyclonal |
| Competing
component | Testosterone-3-CMO
covalently coupled to
paramagnetic particles | 125I iodinated testosterone |
| Solid Phase | paramagnetic particles | Polypropylene tubes coated
with antibodies to testosterone |
| Substrate | ImmuGlow™ (Indoxyl -3-
phosphate and lucigenin) | None |
| Detection | Chemiluminescence | Radiometric |
| Calibration | Factory generated master
curve with single-level
calibration adjustment
every 14 days. | Full calibration curve every
test run using 6 standards. |
| Throughput | Single Sample | Batch of tubes |
| Time to Result | 12 minutes | 180 minutes |
| Reagents
Supplied as | Box of 50 disposable self
contained reagent packs | 100 (200 or 500) coated tubes,
one (two or five) vial(s) of 125I
testosterone, 6 vials of
calibrator |
Performance Characteristics:
| Feature | FastPack™ Testosterone | DPC Coat-A-count | |
|---|---|---|---|
| Precision | |||
| Mean | |||
| ng/mL | Intra-assay | ||
| Between Run | Low 0.14 | ||
| High 7.12 | Reported as a graph | ||
| 4% CV to 7.5%CV over the | |||
| 1ng/mL to 16ng/mL range | |||
| 0.06 SD | |||
| 10.3%C.V. | |||
| Between Analyzer | Low 0.14 | ||
| High 7.12 | Inter-assay | ||
| 0.03 SD | |||
| 3.8%C.V. | Level Mean | ||
| ng/mL | |||
| 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 | ||||
| Sensitivity | 0.13 ng Testosterone/mL | 0.04 ng testosterone/mL | ||
| (4 ng testosterone/dL) | ||||
| Spike Recovery | 94 -110% | 93 to 103% | ||
| Dilution | ||||
| Recovery | 99 - 132% | 96% to 108% | ||
| Method | ||||
| Comparison | versus DPC Coat-A-Count® Total Testosterone: | |||
| n = 144 | ||||
| Range of values (DPC): 0 to 16.9 ng Testosterone/mL | ||||
| Range of values (Fastpack): 0 to 18.4 ng | ||||
| Testosterone/mL | ||||
| y = 1.065x - 0.004 | ||||
| r = 0.930 | ||||
| Interfering | ||||
| Substances | No interference up to: | |||
| Bilirubin | ||||
| 40 mg/dL | ||||
| Hemoglobin | ||||
| 1000 mg/dL | ||||
| Triglycerides | ||||
| 1000 mg/dL | No interference up to: | |||
| 25 mg/dL | ||||
| 600 mg/dL | ||||
| 3000 mg/dL |
| Specificity | ||||
|---|---|---|---|---|
| FastPack® System | DPC Coat-A-Count | |||
| Material Tested | Test Levels | |||
| ng/mL | % Cross- | |||
| reactivity | Test Levels | |||
| ng/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 | Not |
| 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