(277 days)
Not Found
No
The summary describes a standard immunoassay kit and analyzer, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an in-vitro diagnostic immunoassay used to quantitatively determine testosterone levels, aiding in the diagnosis and management of conditions, rather than directly treating them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device 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 description explicitly states it includes physical components like paramagnetic particles, antibody solution, wash buffer, and substrate, contained within a disposable pack, and is designed for use with a physical analyzer. This indicates it is a hardware-based in-vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "It is intended strictly for in-vitro diagnostic use".
- Device Description: The description details a "paramagnetic particle immunoassay for the invitro quantitative determination of total testosterone in human serum or plasma," which is a common type of in vitro diagnostic test.
- Purpose: The intended use is "as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen," which aligns with the purpose of an IVD.
N/A
Intended Use / Indications for Use
The FastPack® Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. 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® Testo Immunoassay is designed for use with the FastPack® System.
Product codes
CDZ
Device Description
The FastPack® Testo Immunoassay for the quantitative determination of testosterone in human serum, lithium heparin plasma and K2 EDTA plasma is designed for use on the FastPack® Analyzer.
The FastPack® Testo Immunoassay Reagents are contained in a disposable pack (FastPack®). Each FastPack® contains the following four components:
-
- Paramagnetic Particles, 150 uL Paramagnetic particles with covalently coupled testosterone in buffer containing 0.1% sodium azide as a preservative.
-
- Testosterone Antibody Solution, 100 uL Antibody solution containing mouse monoclonal antibody labeled with alkaline phosphatase in a protein matrix containing 0.03% Proclin® 150 as a preservative.
- Wash Buffer, 2.0 mL 3. Tris buffer containing surfactants.
- Substrate, 140 uL 4. ImmuGlow™: Indoxyl-3-phosphate and lucigenin in buffer containing preservatives.
The FastPack® Testo Immunoassay is a competitive chemiluminescence assay.
- Primary incubation: Antibody solution (a buffer solution containing a . monoclonal C3-testosterone-specific antibody labeled with alkaline phosphatase )[100 uL] reacts with testosterone from the patients sample, control, or calibrator [100 uL].
- Secondary incubation: The reaction mixture is added to paramagnetic particle . with covalently coupled testosterone. During this incubation, the testosteronecoated beads compete with the sample testosterone.
- Removal of unbound materials: The paramagnetic particles are washed with . wash buffer [0.2 mL/wash] to remove unbound materials.
- Substrate addition and detection: Chemiluminogenic substrate [140 µL] is added . to the solid-phase bound complex and results in "glow" chemiluminescence, which is measured using the FastPack® Analyzer at 37℃.
- The amount of bound labeled-antibody is inversely proportional to the . concentration of testosterone in the sample.
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
Professional use
Description of the training set, sample size, data source, and annotation protocol
An evaluation of the FastPack® Testo Immunoassay was conducted in-house.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Comparative Testing vs Established Methods (Serum): N = 135. Range of observations: 24.0 - 1587.2 ng/dL. Slope: 1.054, y-intercept: 6.5, r² = 0.914.
Comparative Testing vs Established Methods (Lithium Heparin Plasma vs Serum): N = 60. Range of observations: 24.0 - 1440.0 ng/dL. Slope: 0.992, y-intercept: -8.0, r² = 0.987.
Comparative Testing vs Established Methods (K2 EDTA Plasma vs Serum): N = 67. Range of observations: 27.5 - 1425.0 ng/dL. Slope: 0.998, y-intercept: - 10.9, r² = 0.996.
Key Metrics
Measuring Range: 23 ng/dL to 1600 ng/dL
Precision (Total imprecision): 10.9% CV at 712 ng/dL (high sample) and 0.07 SD at 14 ng/dL (low sample).
Linearity: Assay linear throughout dynamic range.
Interfering Substances: No interference from Bilirubin up to concentrations of 10mg/dL. No interference from Hemoglobin up to concentrations of 250mg/dL. Triglyceride demonstrated interference for all concentrations of interferent tested at
§ 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
Image /page/0/Picture/1 description: The image shows the word "Qualigen" in a stylized, bold, black font. The "Q" is large and has a swooping tail that underlines the rest of the word. The letters are slightly slanted to the right, giving the word a dynamic appearance. The overall impression is of a company name or brand logo.
FEB 18 2011
510(k) SAFETY AND EFFECTIVENESS SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
- Submitter's Name, Address, Telephone Number, Contact Person and date the summary l. was prepared.
| Submitter's Name: | Qualigen, Inc. |
|---|---|
| Address: | 2042 Corte Del Nogal |
| Carlsbad, CA 92011 | |
| (760)-918-9165 | |
| Contact Person: | Michael Poirier |
| Senior Vice President, CSO/CTO | |
| mpoirier@qualigeninc.com | |
| Date the summary prepared: | February 18, 2011 |
| Device Name | |
| Trade/Proprietary Name: | FastPack® Testo Immunoassay |
| Common/Usual Name: | Total Testosterone Immunoassay |
| Classification Name: | Total Testosterone Immunoassay, §21 CFR 862.1690 |
| Class: | Class II |
| Trade/Proprietary Name: | FastPack® Testo Immunoassay |
| Common/Usual Name: | Total Testosterone Immunoassay |
| Classification Name: | Total Testosterone Immunoassay, §21 CFR 862.1690 |
| Class: | Class II |
-
- Predicate Device:
FastPack® Testo Immunoassay K021972 510(k) number:
agi 2008 Socie 8 - Lansional CA 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 Of 4 For Startis V. .
1
4. Device Description
The FastPack® Testo Immunoassay for the quantitative determination of testosterone in human serum, lithium heparin plasma and K2 EDTA plasma is designed for use on the FastPack® Analyzer.
FastPack® Testo Immunoassay Reagents
The FastPack® Testo Immunoassay Reagents are contained in a disposable pack (FastPack®). Each FastPack® contains the following four components:
-
- Paramagnetic Particles, 150 uL Paramagnetic particles with covalently coupled testosterone in buffer containing 0.1% sodium azide as a preservative.
-
- Testosterone Antibody Solution, 100 uL Antibody solution containing mouse monoclonal antibody labeled with alkaline phosphatase in a protein matrix containing 0.03% Proclin® 150 as a preservative.
- Wash Buffer, 2.0 mL 3. Tris buffer containing surfactants.
- Substrate, 140 uL 4. ImmuGlow™: Indoxyl-3-phosphate and lucigenin in buffer containing preservatives.
The FastPack® Testo Immunoassay is a competitive chemiluminescence assay.
- Primary incubation: Antibody solution (a buffer solution containing a . monoclonal C3-testosterone-specific antibody labeled with alkaline phosphatase )[100 uL] reacts with testosterone from the patients sample, control, or calibrator [100 uL].
- Secondary incubation: The reaction mixture is added to paramagnetic particle . with covalently coupled testosterone. During this incubation, the testosteronecoated beads compete with the sample testosterone.
- Removal of unbound materials: The paramagnetic particles are washed with . wash buffer [0.2 mL/wash] to remove unbound materials.
- Substrate addition and detection: Chemiluminogenic substrate [140 µL] is added . to the solid-phase bound complex and results in "glow" chemiluminescence, which is measured using the FastPack® Analyzer at 37℃.
- The amount of bound labeled-antibody is inversely proportional to the . concentration of testosterone in the sample.
2
5. Intended Use:
The FastPack® Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. 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® Testo Immunoassay is designed for use with the FastPack® System.
-
- Assessment of Performance:
An evaluation of the FastPack® Testo Immunoassay was conducted in-house. The studies demonstrated the safety and effectiveness of the device when used as intended.
- Assessment of Performance:
-
- Comparison to Predicate Device.
| CHARACTERISTIC | Qualigen FastPack® Testo
Immunoassay Serum or Plasma | Qualigen FastPack® Testo Serum
Only K021972 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | for the in-vitro quantitative
determination of total testosterone in
human serum or lithium-heparin or
K2 EDTA plasma. The FastPack®
Testo Immunoassay is designed for
use with the FastPack® System. | for the in-vitro quantitative
determination of total testosterone in
human serum. The FastPack® Testo
Immunoassay is designed for use
with the FastPack® System. |
| Indications for Use | Quantitative determination of total
testosterone. | Quantitative determination of total
testosterone. |
| Sample | Serum or plasma (heparin or K2
EDTA) | Serum |
| Sample Preparation | Standard processing for serum or
plasma | Standard processing for serum |
| Calibration | An active calibration is required
every 14 days and with each new lot;
system includes calibration solutions
and instructions. | An active calibration is required
every 14 days and with each new lot;
system includes calibration solutions
and instructions. |
| Methodology | The FastPack® Testo Immunoassay
is a paramagnetic particle,
chemiluminescent immunoassay. | The FastPack® TestoImmunoassay is
a paramagnetic particle,
chemiluminescent immunoassay. |
| Testing Environment | Professional use | Professional use |
| Measuring Range | 23 ng/dL to 1600 ng/dL | 23 ng/dL to 1600 ng/dL |
| Precision | Total imprecision is 10.9% CV at
712 ng/dL (high sample) and 0.07
SD at 14 ng/dL (low sample) | Total imprecision is 10.9% CV at 712
ng/dL (high sample) and 0.07 SD at
14 ng/dL (low sample) |
| Linearity | Assay linear throughout dynamic
range | Assay linear throughout dynamic
range |
Similarities / Differences between EastPack® Testo Serum & Plasma Assays
3
| Interfering Substances | No interference from Bilirubin up to
concentrations of 10mg/dL. No
interference from Hemoglobin up
to concentrations of 250mg/dL.
Triglyceride demonstrated
interference for all concentrations of
interferent tested at