(185 days)
Not Found
Not Found
No
The summary describes a quality control kit for an immunoassay, which is a chemical analysis method. There is no mention of AI or ML in the intended use, device description, or any other section. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a quality control material intended for verifying the calibration and reportable range of an immunoassay, not for treating or diagnosing a medical condition.
No
Explanation: The device is a "Method Verification Kit" used for quality control and calibration verification of an immunoassay, not for diagnosing patient conditions.
No
The device description explicitly states the components are in liquid form, in vials, indicating a physical, non-software-only product.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit consists of "assayed quality control materials for verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay". This indicates that the materials are used in vitro (outside the body) to assess the performance of another diagnostic test (the FastPack® Total PSA Immunoassay).
- Device Description: The description mentions the components are in "liquid form, in vials, from which the user can directly remove sample". This further supports the idea that these are reagents or materials used in a laboratory setting for testing.
- Purpose: The purpose is to "meet CLIA requirements" for verifying the performance of a diagnostic immunoassay. This is a common function of IVD quality control materials.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the intended use and description clearly align with the definition of an IVD, specifically a quality control material used with an IVD immunoassay.
N/A
Intended Use / Indications for Use
The FastPack® Total PSA Method Verification Kit consists of assayed quality control materials for verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay to meet CLIA requirements.
Product codes
JJX
Device Description
FastPack® PSA Method Verification Kit
The FastPack® Total PSA Method Verification kit components are in liquid form, in vials, from which the user can directly remove sample. They are formulated at three (3) levels packaged together as a kit.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
FastPack® Controls
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR - 2 2007
510(k) Summary
FastPack® Total PSA Method Verification Kit
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 1. | Submitter
name, address,
contact | Qualigen, Incorporated
2042 Corte del Nogal
Carlsbad, CA 92011 | |
|----|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| | | Telephone:
Fax: | (760) 918-9165
(760) 918-9127 |
| | | Contact Person: | Melissa Saam |
| | | Date Prepared: | September 28, 2006 |
| 2. | Device name | Proprietary name: | FastPack® Total PSA Method Verification Kit |
| | | Common name: | Total PSA Quality Controls |
| | | Classification Name: | Single (specified) Analyte Controls (assayed and
unassayed) |
| 3. | Predicate
device | FastPack® Controls | |
| 4. | Device
description | FastPack® PSA Method Verification Kit
The FastPack® Total PSA Method Verification kit components are in liquid
form, in vials, from which the user can directly remove sample. They are
formulated at three (3) levels packaged together as a kit. | |
| 5. | Intended use | The FastPack® Total PSA Method Verification Kit consists of assayed
quality control materials for verification of the calibration and reportable
range of the FastPack® Total PSA Immunoassay to meet CLIA
requirements. | |
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1
The following table compares the FastPack® PSA Method Verification Kit 6. Comparison with the FastPack® Calibrators. to Predicate
·
:
.
Device
| Feature | Predicate Device | New Device |
|---|---|---|
| FastPack® Controls | FastPack® Total PSA | |
| Method Verification Kit | ||
| Intended Use | 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 or plasma. | Assayed quality control | |
| materials for the | ||
| verification of the | ||
| calibration and reportable | ||
| range of the FastPack® | ||
| Total PSA Immunoassay | ||
| to meet CLIA | ||
| requirements. | ||
| Analytes | Total PSA | Total PSA |
| Matrix | Bovine Serum Albumin | Bovine Serum Albumin |
| Form | Liquid | Liquid |
| Volume | 5.0 mL | 5.0 mL |
| Levels | 2 | 3 |
| PSA | 2 ng/mL | 0 ng/mL |
| Concentrations | 10 ng/mL | 25 ng/mL |
| 50 ng/mL |
:
:
:
.
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:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 2 2007
Qualigen, Inc. c/o Ms. Melissa Saam Manager, QA/RA 2042 Corte Del Nogal Carlsbad, CA 92011
Re: K062957
Trade/Device Name: Qualigen™ FastPack® Total PSA Method Verification Kit Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: March 13, 2007 Received: March 19, 2007
Dear Ms. Saam:
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
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FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ia M chan
for Dr Robert Becker
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: FastPack® Total PSA Method Verification Kit
Indications for Use:
The FastPack® Total PSA Method Verification Kit consists of assayed quality control materials for verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay to meet CLIA requirements.
Prescription Use) × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mona M. Chan
Division Sign-Off
510(k)
Office of In Vitro Diagnostic Device Evaluation and Safety
062957
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