(94 days)
Not Found
No
The summary describes a quality control kit for an immunoassay system and does not mention any AI or ML components.
No
The device is a quality control kit used to verify the accuracy and precision of other systems that quantitatively determine analytes, rather than directly treating a disease or condition.
No
Explanation: This device is a quality control kit used to verify the accuracy and precision of diagnostic systems. It does not directly diagnose a medical condition in a patient.
No
The device description clearly states the device is a "Control Kit" prepared in a "synthetic matrix containing chemicals, preservatives, and stabilizers with added analyte constituents of human and synthesized origin," and is provided in "liquid form." This indicates a physical, chemical-based product, not software.
Based on the provided information, the FastPack® Control Kit is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it 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." This indicates it's used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description mentions it's prepared in a synthetic matrix with added analyte constituents, further supporting its use as a control for laboratory testing.
- Analytes: The listed analytes (FT4, hCG, Testosterone, tPSA, TSH) are all substances commonly measured in clinical laboratory settings for diagnostic purposes.
- Predicate Devices: The predicate devices listed are also described as "Immunology Control" and "FastPack® Controls," which are typical IVD control products.
Therefore, the FastPack® Control Kit fits the definition of an In Vitro Diagnostic device as it is intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / 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)
Product codes
JJY
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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: 120 days at 2-8 ℃
Shelf Life Stability: 18 months at 2-8 ℃
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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
1
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
2
۰۰۰ :
Comparison of new device to predicate devices
| Characteristic | FastPack® Control
Kit | Predicate Devices
Immunology
Control,
containing FT4,
testosterone, and
hCG (K960824) | Predicates:
FastPack®
Controls for PSA
(K003095) and
FastPack® TSH
Controls
(K052301) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Immunology
Control is intended
for use in the
clinical laboratory
as a consistent test
sample of known
concentration for
monitoring assay
conditions in many
immunological
determinations.
Include
immunology
control with patient
serum specimens
when assaying for
any of the listed
constituents. The
user can compare
observations with
expected ranges as
a means of assuring
consistent
performance of
reagent and
instrument. | PSA: The
FastPack®
Controls are
assayed quality
control materials
for the verification
of the accuracy and
precision of the
FastPack®
Analyzer system
when used for the
quantitative
determination of
PSA in human
serum and plasma.
TSH: The
FastPack®
Controls are
assayed quality
control materials
for the verification
of the accuracy and
precision of the
FastPack® System
when used for the
quantitative
determination of
TSH in human
plasma. |
| Matrix | Synthetic | Human serum | PSA: BSA
TSH: BSA |
| Form | Liquid | Liquid | Liquid |
| Levels | 2 | 3 | 2 |
| Fill Volume | Each Multi-Analyte
Control kit contains 1
vial of Level 1 and 1
vial of Level 2, each
filled to 5 mL | Each Control Kit
contains 2 vials of
Level 1, 2 and 3,
each filled to 5 mL | Each Control Kit
contains 1 vial of
Level 1 and 1 vial
of Level 2, each
filled to 5 mL |
| Characteristic | FastPack® Control
Kit | Immunology
Control,
containing FT4,
testosterone, and
hCG (K960824) | Predicates:
FastPack®
Controls for PSA
(K003095) and
FastPack® TSH
Controls
(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
Life) | 18 months at 2-8 °C | 3 years at -20 °C | 12 months at 2-8 °C |
| Analytes | Contains:
- Free Thyroxine (FT4)
- Human Chorionic
Gonadotropin (hCG) - Testosterone
- Total Prostate Specific
Antigen (tPSA) - Thyroid Stimulating
Hormone (TSH) | Contains FT4,
testosterone, and
hCG | PSA (K003095),
TSH (K052301) |
Similarities/Differences between FastPack® Multi-Analyte Assayed Control and Predicate Devices
Section 6 - 510(k) Summary of Safety and Effectiveness
3
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 ℃
4
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
5
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.
6
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:
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