The FastPack® Control Kit is an assayed quality control for the verification of the accuracy and precision of the FastPack® and FastPack® IP Systems when used for the quantitative determination of the analytes listed in the package insert. The following analytes are included in the package insert:

Free Thyroxine (FT4)
Human Chorionic Gonadotropin (hCG)
Testosterone
Total Prostate Specific Antigen (tPSA)
Thyroid Stimulating Hormone (TSH)

Device Description

FastPack® Control Kit is prepared in a synthetic matrix containing chemicals, preservatives, and stabilizers with added analyte constituents of human and synthesized origin. The control is provided in liquid form for convenience.

AI/ML Overview

This document describes a K123725 FastPack® Control Kit, which is a quality control material used to verify the accuracy and precision of immunoassay systems (FastPack® and FastPack® IP Systems). As such, the "acceptance criteria" and "device performance" in this context refer to the stability and value assignment of the control material, not a diagnostic or AI algorithm's performance on patient data.

Here's an analysis of the provided information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are related to its stability and the accurate assignment of analyte values.

Acceptance Criteria Category	Specific Criteria/Study Goal	Reported Device Performance/Outcome
Value Assignment	Establish mean, standard deviation (SD), and percent coefficient of variation (% CV) for each analyte at each level, and define a reported range.	FastPack® Control Kit lots are value-assigned on 6 FastPack® analyzers with three determinations for each of three lots of FastPack® reagents, using two separate calibrations. This yields 36 determinations for each analyte at each of two levels. Mean, SD, and %CV are calculated, and a range is reported based on mean ± 3SD for each level and analyte.
Open Vial Stability	Determine the period the control remains stable after opening at 2-8 ℃.	120 days at 2-8 ℃
Shelf Life Stability	Determine the total storage period for an unopened vial at 2-8 ℃.	18 months at 2-8 ℃

2. Sample Size and Data Provenance (for test set)

This device is a quality control material, not a diagnostic device that processes patient data. Therefore, the concept of a "test set" in the context of patient data, country of origin, or retrospective/prospective data is not applicable here.

The "test set" for this device would be the samples of the control material itself that are used for the value assignment and stability studies.

Sample Size for Value Assignment: For each analyte and each of the two control levels, 36 determinations were performed (6 FastPack® analyzers * 3 reagent lots * 2 calibrations = 36 determinations).
Data Provenance: Not applicable in the sense of patient data. The data originates from the internal testing conducted by Qualigen, Inc., presumably at their facility in Carlsbad, CA, as part of their manufacturing and quality control process. The studies are prospective for the purpose of validating the control material.

3. Number of Experts and Qualifications for Ground Truth (for test set)

Again, this is a quality control material. "Ground truth" for this device is based on analytical measurement results from calibrated instruments and established statistical methods, not expert human interpretation of clinical data. Therefore, experts in the sense of radiologists or clinicians are not involved in establishing the "ground truth" for the performance of the control material itself. The "experts" would be the scientific and technical personnel (e.g., analytical chemists, quality control specialists) at Qualigen, Inc. who perform these measurements and statistical analyses. Their qualifications are inherent in their roles within a medical device manufacturer.

4. Adjudication Method (for test set)

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to conflicts in human expert interpretations of clinical data. The value assignment and stability studies for a control material rely on direct analytical measurements and statistical calculations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is designed to assess and compare the performance of human readers, often with and without AI assistance, on diagnostic tasks (cases). This is not relevant to a quality control material.

6. Standalone (Algorithm Only) Performance Study

No. This device is an assayed quality control material, not an algorithm. Its "performance" is its ability to provide stable and accurately assigned values, which is assessed through analytical testing, not by an algorithm's output.

7. Type of Ground Truth Used

The ground truth used for this device is based on analytical measurements and statistical calculations from repeated testing on multiple instruments and reagent lots. It involves:

Quantitative measurements of analyte concentrations using the FastPack® and FastPack® IP Systems.
Statistical analysis to determine means, standard deviations, and coefficients of variation.
Defined ranges (e.g., mean ± 3SD) for each analyte and level.

8. Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning algorithms. This device is a biochemical control material, not an AI model. Therefore, there is no "training set" in the conventional sense. The "training" here would refer to the process of manufacturing and calibrating the control material itself, and the data generated during the value assignment process serves to characterize each manufactured lot.

9. How the Ground Truth for the Training Set was Established

As noted above, there is no "training set" for an algorithm. The "ground truth" for the control material's characteristics (its assigned values and stability) is established through rigorous analytical testing and statistical analysis by the manufacturer, as described in section 3 ("Value Assignment of Analytes") of the 510(k) summary. This process quantifies the target values and acceptable ranges for each analyte within the control kit.

Summary

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March 8, 2013

K123725

MAR 0 8 2013

SECTION 6 · 510 (k)SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.

510(k) Number:

Submitter:

Qualigen, Inc. 2042 Corte Del Nogal Carlsbad, CA 92011 (760) 918-9165 Telephone: Facsimile: (760) 918-9127

Contact Person:

Mr. Michael Poirier Senior Vice President, Chief Technical Officer, Chief Scientific Officer (760) 918-9165 x227 Telephone: Facsimile: (760) 918-9127 Email: mpoirier@qualigeninc.com Date Prepared: March 8, 2013

Device Identification

Trade Name: FastPack® Control Kit Multi-Analyte Controls, All Kinds (Assayed) Common Name: Classification: Class I, reserved Product Code: JJY Regulation Number: 21 CFR § 862.1660

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Devices to Which Substantial Equivalence is Claimed

Immunology Control (containing FT4, testosterone, and hCG) Medical Analysis Systems, Camarillo, California K960824

FastPack® Controls (containing PSA) Qualigen, Inc. Carlsbad, California K003095

FastPack® TSH Controls

Qualigen, Inc.

Carlsbad, California K052301

Device Description

Intended Use

Free Thyroxine (FT4)
Human Chorionic Gonadotropin (hCG)
Testosterone
Total Prostate Specific Antigen (tPSA)
Thyroid Stimulating Hormone (TSH)

Section 6 - 510(k) Summary of Safety and Effectiveness

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۰۰۰ :

Comparison of new device to predicate devices

Characteristic	FastPack® ControlKit	Predicate DevicesImmunologyControl,containing FT4,testosterone, andhCG (K960824)	Predicates:FastPack®Controls for PSA(K003095) andFastPack® TSHControls(K052301)
Intended Use	The FastPack® ControlKit is an assayed qualitycontrol for theverification of theaccuracy and precisionof the FastPack® andFastPack® IP Systemswhen used for thequantitativedetermination of theanalytes listed in thepackage insert.	ImmunologyControl is intendedfor use in theclinical laboratoryas a consistent testsample of knownconcentration formonitoring assayconditions in manyimmunologicaldeterminations.Includeimmunologycontrol with patientserum specimenswhen assaying forany of the listedconstituents. Theuser can compareobservations withexpected ranges asa means of assuringconsistentperformance ofreagent andinstrument.	PSA: TheFastPack®Controls areassayed qualitycontrol materialsfor the verificationof the accuracy andprecision of theFastPack®Analyzer systemwhen used for thequantitativedetermination ofPSA in humanserum and plasma.TSH: TheFastPack®Controls areassayed qualitycontrol materialsfor the verificationof the accuracy andprecision of theFastPack® Systemwhen used for thequantitativedetermination ofTSH in humanplasma.
Matrix	Synthetic	Human serum	PSA: BSATSH: BSA
Form	Liquid	Liquid	Liquid
Levels	2	3	2
Fill Volume	Each Multi-AnalyteControl kit contains 1vial of Level 1 and 1vial of Level 2, eachfilled to 5 mL	Each Control Kitcontains 2 vials ofLevel 1, 2 and 3,each filled to 5 mL	Each Control Kitcontains 1 vial ofLevel 1 and 1 vialof Level 2, eachfilled to 5 mL
Characteristic	FastPack® ControlKit	ImmunologyControl,containing FT4,testosterone, andhCG (K960824)	Predicates:FastPack®Controls for PSA(K003095) andFastPack® TSHControls(K052301)
Open Vial Stability	120 days at 2-8 °C	30 days at 2-8 °C	9 months at 2-8 °C
Storage Unopened (ShelfLife)	18 months at 2-8 °C	3 years at -20 °C	12 months at 2-8 °C
Analytes	Contains:- Free Thyroxine (FT4)- Human ChorionicGonadotropin (hCG)- Testosterone- Total Prostate SpecificAntigen (tPSA)- Thyroid StimulatingHormone (TSH)	Contains FT4,testosterone, andhCG	PSA (K003095),TSH (K052301)

Similarities/Differences between FastPack® Multi-Analyte Assayed Control and Predicate Devices

Section 6 - 510(k) Summary of Safety and Effectiveness

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March 8, 2013

Qualigen, Inc. Premarket Notification Section 510(k) FastPack® Control Kit

Value Assignment of Analytes

FastPack® Control Kit lots are value-assigned on 6 FastPack® analyzers with three determinations for each of three lots of FastPack® reagents and using two separate calibrations to yield 36 determinations for each analyte at each of two Levels. Mean, standard deviation (SD), and percent coefficient of variation (% CV) for each level for each analyte are calculated and a range reported based on mean ± 3SD for each level for each analyte. However, laboratories should establish their own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of the FastPack® Control Kit as a result of laboratory technique, instrumentation, and reagents.

Stability

Stability studies have been performed for the FastPack® Control Kit to determine the open vial and closed vial shelf-life claims. Product claims are as follows:

Open Vial Stability: Shelf Life Stability:

120 days at 2-8 ℃ 18 months at 2-8 ℃

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SUMMARY

The information provided in this pre-market notification indicates that the FastPack® Control Kit is substantially equivalent to the stated predicate devices. The information further indicates that the FastPack® Control Kit is safe and effective for its stated intended use.

Section 6 - 510(k) Summary of Safety and Effectiveness

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 8, 2013

Qualigen, Inc. C/O Michael Poirier 2042 Corte Del Nogal Carlsbad, CA 92011

Re: K123725

Trade/Device Name: FastPack® Control Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Code: JJY Dated: February 05, 2013 Received: February 11, 2013 ·

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123725

Device Name: FastPack® Control Kit

Indications for Use:

Free Thyroxine (FT4)
Human Chorionic Gonadotropin (hCG)
Testosterone
Total Prostate Specific Antigen (tPSA)
Thyroid Stimulating Hormone (TSH)

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

YungMDChan-S

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K123725

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.