The FastPack® Testo Immunoassay is a paramagnetic particle immunoassay for the invitro quantitative determination of total testosterone in human serum or plasma. The FastPack® Testo Immunoassay is designed for use with the FastPack® 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 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, Testosterone Antibody Solution, Wash Buffer, and Substrate. The FastPack® Testo Immunoassay is a competitive chemiluminescence assay.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Qualigen FastPack® Testo Immunoassay, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating equivalence to the predicate device (FastPack® Testo Immunoassay K021972), particularly for the new sample types (lithium heparin plasma and K2 EDTA plasma). The performance data below reflects the device meeting these criteria by achieving comparable results to the predicate, and demonstrating linearity and acceptable precision.

Characteristic	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (FastPack® Testo Immunoassay Serum or Plasma)
Measuring Range	23 ng/dL to 1600 ng/dL	23 ng/dL to 1600 ng/dL
Precision (High Sample)	Total imprecision 10.9% CV at 712 ng/dL	Total imprecision 10.9% CV at 712 ng/dL
Precision (Low Sample)	Total imprecision 0.07 SD at 14 ng/dL	Total imprecision 0.07 SD at 14 ng/dL
Linearity	Assay linear throughout dynamic range	Assay linear throughout dynamic range
Interfering Substances
Bilirubin	No interference up to 10 mg/dL	No interference up to 10 mg/dL
Hemoglobin	No interference up to 250 mg/dL	No interference up to 250 mg/dL
Triglyceride	Interference < 100 ng/dL testosterone	Interference for all concentrations of interferent tested at < 100 ng/dL of testosterone. No visibly hemolyzed or cloudy (lipemic) samples should be used.
Cross-reactivity
5-α-DHT	No significant cross-reactivity	No significant cross-reactivity
Androstenediol	Magnitude < 4%	Magnitude < 4%
19-Norethisterone Acetate	Magnitude < 4%	Magnitude < 4%
Comparative Testing vs. Established Methods
Serum (N=135)	Slope: ~1.0, Y-intercept: ~0, r²: ~1.0	Slope: 1.054, y-intercept: 6.5, r² = 0.914
Lithium Heparin Plasma vs Serum (N=60)	Slope: ~1.0, Y-intercept: ~0, r²: ~1.0	Slope: 0.992, y-intercept: -8.0, r² = 0.987
K2 EDTA Plasma vs Serum (N=67)	Slope: ~1.0, Y-intercept: ~0, r²: ~1.0	Slope: 0.998, y-intercept: -10.9, r² = 0.996

Study Details

Sample sizes used for the test set and the data provenance:
- Serum: N = 135
- Lithium Heparin Plasma: N = 60
- K2 EDTA Plasma: N = 67
- Data Provenance: The document does not specify the country of origin. It indicates the studies were "conducted in-house" which typically implies internal testing by the manufacturer. It does not state whether the data was retrospective or prospective, but clinical validation studies for in-vitro diagnostics are generally prospective or use carefully selected archived samples that mimic prospective collection.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth for the test set. For quantitative immunoassays, the "ground truth" is typically established by comparative testing against an established, legally marketed method or a reference method. The comparison study uses the results from the predicate device (FastPack® Testo Immunoassay K021972) or other "established methods" as the reference for comparison, not expert consensus.
Adjudication method for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for qualitative or imaging-based diagnostics where human interpretation of results is involved and there might be discrepancies. For quantitative laboratory assays, the result is a numerical value, and the comparison is statistical against a reference method.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is an in-vitro diagnostic immunoassay for quantitative determination of testosterone, not an imaging device or an AI-assisted diagnostic tool that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, this is essentially a standalone device performance study. The FastPack® Testo Immunoassay is an automated immunoassay system. Its performance (accuracy, precision, linearity, interference) is evaluated intrinsically, independent of human interpretation or assistance beyond operating the device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth was established by comparison to "Established Methods" and the predicate device (FastPack® Testo Immunoassay K021972) for serum samples, and comparison to serum results for plasma samples. This means the clinical performance of the device was assessed by correlating its quantitative measurements with those obtained from already accepted, legally marketed, or gold-standard laboratory methods.
The sample size for the training set:
The document does not explicitly state the sample size for a "training set." For an immunoassay like this, method development and optimization would occur internally, potentially using numerous samples, but it's not typically referred to as a "training set" in the context of device approval unless machine learning/AI is involved. The listed sample sizes (N=135, N=60, N=67) are for the validation or test sets to demonstrate performance characteristics.
How the ground truth for the training set was established:
Not applicable, as a distinct "training set" with ground truth established in a formal, reported manner (like for an AI algorithm) is not mentioned or relevant for this type of immunoassay device submission. Method development and optimization would rely on established laboratory practices to ensure reagents and assay parameters lead to accurate and precise measurements.

Summary

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K101388

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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 NogalCarlsbad, CA 92011(760)-918-9165
Contact Person:	Michael PoirierSenior Vice President, CSO/CTOmpoirier@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

1. 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. .

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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:

1. Paramagnetic Particles, 150 uL Paramagnetic particles with covalently coupled testosterone in buffer containing 0.1% sodium azide as a preservative.
1. 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.

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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.

1. 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.
1. Comparison to Predicate Device.

CHARACTERISTIC	Qualigen FastPack® TestoImmunoassay Serum or Plasma	Qualigen FastPack® Testo SerumOnly K021972
Intended Use	for the in-vitro quantitativedetermination of total testosterone inhuman serum or lithium-heparin orK2 EDTA plasma. The FastPack®Testo Immunoassay is designed foruse with the FastPack® System.	for the in-vitro quantitativedetermination of total testosterone inhuman serum. The FastPack® TestoImmunoassay is designed for usewith the FastPack® System.
Indications for Use	Quantitative determination of totaltestosterone.	Quantitative determination of totaltestosterone.
Sample	Serum or plasma (heparin or K2EDTA)	Serum
Sample Preparation	Standard processing for serum orplasma	Standard processing for serum
Calibration	An active calibration is requiredevery 14 days and with each new lot;system includes calibration solutionsand instructions.	An active calibration is requiredevery 14 days and with each new lot;system includes calibration solutionsand instructions.
Methodology	The FastPack® Testo Immunoassayis a paramagnetic particle,chemiluminescent immunoassay.	The FastPack® TestoImmunoassay isa 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 at712 ng/dL (high sample) and 0.07SD at 14 ng/dL (low sample)	Total imprecision is 10.9% CV at 712ng/dL (high sample) and 0.07 SD at14 ng/dL (low sample)
Linearity	Assay linear throughout dynamicrange	Assay linear throughout dynamicrange

Similarities / Differences between EastPack® Testo Serum & Plasma Assays

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Interfering Substances	No interference from Bilirubin up toconcentrations of 10mg/dL. Nointerference from Hemoglobin upto concentrations of 250mg/dL.Triglyceride demonstratedinterference for all concentrations ofinterferent tested at < 100 ng/dL oftestosterone. Based on these studies,no visibly hemolyzed or cloudy(lipemic) samples should be usedwith this assay.	No interference from Bilirubin up toconcentrations of 10mg/dL. Nointerference from Hemoglobin upto concentrations of 250mg/dL.Triglyceride demonstratedinterference for all concentrations ofinterferent tested at < 100 ng/dL oftestosterone. Based on these studies,no visibly hemolyzed or cloudy(lipemic) samples should be usedwith this assay.
Cross-reactivity	No significant cross-reactivity fromhigh levels of 5-α-DHT.Androstenediol and 19-Norethisterone Acetate generated thehighest cross-reactivity in this studythough although the magnitude waslimited to <4%.	No significant cross-reactivity fromhigh levels of 5-α-DHT.Androstenediol and 19-Norethisterone Acetate generated thehighest cross-reactivity in this studythough although the magnitude waslimited to <4%.
Comparative Testing vs	Serum	Serum
Established Methods	N = 135	N = 135
	Range of observations:	Range of observations:
(Deming Regressions)	24.0 - 1587.2 ng/dL	24.0 - 1587.2 ng/dL
	Slope: 1.054	Slope: 1.054
	y-intercept: 6.5$r² = 0.914$	y-intercept: 6.5$r² = 0.914$

	Lithium Heparin Plasma vs SerumN = 60Range of observations:24.0 - 1440.0 ng/dLSlope: 0.992y-intercept: -8.0$r² = 0.987$K2 EDTA Plasma vs SerumN = 67Range of observations:27.5 - 1425.0 ng/dLSlope: 0.998y-intercept: - 10.9$r² = 0.996$	Lithium Heparin Plasma vs SerumN = 60Range of observations:24.0 - 1440.0 ng/dLSlope: 0.992y-intercept: -8.0$r² = 0.987$K2 EDTA Plasma vs SerumN = 67Range of observations:27.5 - 1425.0 ng/dLSlope: 0.998y-intercept: - 10.9$r² = 0.996$

1. Conclusions
  The results of the evaluation studies of the FastPack® Testo Immunoassay demonstrate
  that the device is equivalent in performance to the predicate device and suitable for its intended use.

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Qualigen, Inc. c/o Mr. Michael S. Poirier Senior Vice President 2042 Corte Del Nogal, Suite B Carlsbad, CA 92011-1438

Re: K101388

Trade/Device Name: Fastpack® Testo Immunoassay Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone test system Regulatory Class: I, reserved Product Code: CDZ Dated: February 3, 2011 Received: February 4, 2011

FEB 18 201

Dear Mr. Poirier:

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 –

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(K) Number (if known): K101388

Device Name:

Indications for Use:

Prescription Use XX Use (Part 21 CFR 801 Subpart D) Subpart C)

AND/OR

Over -the-Counter

(Part 21 CFR 801

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of 1 of Intended Use

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_K 101 388

Regulation Number and Section

§ 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.