FASTPACK CONTROL KIT

K123725 · Qualigen, Inc. · JJY · Mar 8, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123725
• Device Name: FASTPACK CONTROL KIT
• Applicant: Qualigen, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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 Story

FastPack® Control Kit is a liquid, multi-analyte assayed quality control product; contains synthetic matrix with chemicals, preservatives, stabilizers, and human/synthesized analyte constituents (FT4, hCG, testosterone, tPSA, TSH). Used in clinical laboratories to monitor performance of FastPack® and FastPack® IP Systems. Healthcare providers compare observed control values against established ranges to verify assay accuracy and precision. Benefits include ensuring consistent reagent and instrument performance, thereby supporting reliable clinical decision-making for patient diagnostic testing.

Clinical Evidence

No clinical data. Bench testing only. Stability protocols (shelf-life and open-vial) were reviewed and accepted. Value assignment performed via replicate analysis using six FastPack analyzers, three reagent lots, and two calibrations.

Technological Characteristics

Matrix: Bovine serum albumin (BSA). Form: Ready-to-use liquid. Fill volume: 5 mL. Storage: 2–8°C. Stability: 18 months shelf-life, 120 days open-vial. Analyte traceability: Commercially available standards.

Indications for Use

Indicated for use as an assayed quality control material to verify accuracy and precision of FastPack® and FastPack® IP Systems for quantitative determination of FT4, hCG, testosterone, tPSA, and TSH in clinical laboratory settings.

Regulatory Classification

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.

Predicate Devices

• Immunology Control (k960824)
• FastPack® Controls for PSA (k003095)
• FastPack® TSH Controls (k052301)

Submission Summary (Full Text)

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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 [phone] Telephone: Facsimile: [phone]

## Contact Person:

Mr. Michael Poirier Senior Vice President, Chief Technical Officer, Chief Scientific Officer [phone] x227 Telephone: Facsimile: [phone] Email: [e-mail] 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

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.

#### Intended Use

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)

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

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## Comparison of new device to predicate devices

| Characteristic | FastPack® Control<br>Kit | Predicate Devices<br>Immunology<br>Control,<br>containing FT4,<br>testosterone, and<br>hCG (K960824) | Predicates:<br>FastPack®<br>Controls for PSA<br>(K003095) and<br>FastPack® TSH<br>Controls<br>(K052301) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The FastPack® Control<br>Kit is an assayed quality<br>control for the<br>verification of the<br>accuracy and precision<br>of the FastPack® and<br>FastPack® IP Systems<br>when used for the<br>quantitative<br>determination of the<br>analytes listed in the<br>package insert. | Immunology<br>Control is intended<br>for use in the<br>clinical laboratory<br>as a consistent test<br>sample of known<br>concentration for<br>monitoring assay<br>conditions in many<br>immunological<br>determinations.<br>Include<br>immunology<br>control with patient<br>serum specimens<br>when assaying for<br>any of the listed<br>constituents. The<br>user can compare<br>observations with<br>expected ranges as<br>a means of assuring<br>consistent<br>performance of<br>reagent and<br>instrument. | PSA: The<br>FastPack®<br>Controls are<br>assayed quality<br>control materials<br>for the verification<br>of the accuracy and<br>precision of the<br>FastPack®<br>Analyzer system<br>when used for the<br>quantitative<br>determination of<br>PSA in human<br>serum and plasma.<br>TSH: The<br>FastPack®<br>Controls are<br>assayed quality<br>control materials<br>for the verification<br>of the accuracy and<br>precision of the<br>FastPack® System<br>when used for the<br>quantitative<br>determination of<br>TSH in human<br>plasma. |
| Matrix | Synthetic | Human serum | PSA: BSA<br>TSH: BSA |
| Form | Liquid | Liquid | Liquid |
| Levels | 2 | 3 | 2 |
| Fill Volume | Each Multi-Analyte<br>Control kit contains 1<br>vial of Level 1 and 1<br>vial of Level 2, each<br>filled to 5 mL | Each Control Kit<br>contains 2 vials of<br>Level 1, 2 and 3,<br>each filled to 5 mL | Each Control Kit<br>contains 1 vial of<br>Level 1 and 1 vial<br>of Level 2, each<br>filled to 5 mL |
| Characteristic | FastPack® Control<br>Kit | Immunology<br>Control,<br>containing FT4,<br>testosterone, and<br>hCG (K960824) | Predicates:<br>FastPack®<br>Controls for PSA<br>(K003095) and<br>FastPack® TSH<br>Controls<br>(K052301) |
| Open Vial Stability | 120 days at 2-8 °C | 30 days at 2-8 °C | 9 months at 2-8 °C |
| Storage Unopened (Shelf<br>Life) | 18 months at 2-8 °C | 3 years at -20 °C | 12 months at 2-8 °C |
| Analytes | Contains:<br>- Free Thyroxine (FT4)<br>- Human Chorionic<br>Gonadotropin (hCG)<br>- Testosterone<br>- Total Prostate Specific<br>Antigen (tPSA)<br>- Thyroid Stimulating<br>Hormone (TSH) | Contains FT4,<br>testosterone, and<br>hCG | PSA (K003095),<br>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 [phone] or [phone] 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:

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)

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