(185 days)
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.
The 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.
The provided text is a 510(k) summary for the FastPack® Total PSA Method Verification Kit. It describes the device, its intended use, and compares it to a predicate device. However, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for diagnostic devices.
The document focuses on demonstrating substantial equivalence to a predicate device based on similar features and intended use. The "Method Verification Kit" itself is a quality control material used to verify the calibration and reportable range of another immunoassay (the FastPack® Total PSA Immunoassay), rather than a device that directly measures a patient's analyte. Therefore, the "performance" of this kit is assessed by its characteristics as a quality control material (e.g., PSA concentrations, matrix, form), not by diagnostic accuracy metrics.
Here's a breakdown of the requested information based on the provided text, with explicit statements where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria or a numerical performance table for the "FastPack® Total PSA Method Verification Kit" are provided in this document. The document states it is a "Method Verification Kit" and compares its features to a "Predicate Device" in a table. This comparison highlights attributes like intended use, analytes, matrix, form, volume, and levels of PSA concentrations. It does not present performance metrics against predefined acceptance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for the Method Verification Kit's performance. | Not specified in terms of performance metrics. |
| Comparison to Predicate Device (Features): | |
| Intended Use | New Device: 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 |
| Matrix | Bovine Serum Albumin |
| Form | Liquid |
| Volume | 5.0 mL |
| Levels | 3 levels (0 ng/mL, 25 ng/mL, 50 ng/mL) |
2. Sample size used for the test set and the data provenance
- Sample size from the test set: Not applicable/Not provided. The kit itself is a quality control material, not a diagnostic test performed on patient samples.
- Data provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable/Not provided. This device is a quality control material, not a diagnostic device requiring expert interpretation of results.
- Qualifications of experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/None. This device is a quality control material.
5. 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
- MRMC study: No. This device is a quality control material and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance study: No. This device is a quality control material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not applicable/Not provided in the context of diagnostic accuracy. For the quality control material itself, the specified PSA concentrations (0 ng/mL, 25 ng/mL, 50 ng/mL) would serve as the "true" values for verifying the immunoassay. How these concentrations were established (e.g., gravimetric preparation against a standard) is not detailed in this document.
8. The sample size for the training set
- Training set sample size: Not applicable/Not provided. This document describes a quality control material, not a machine learning model.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable/Not provided.
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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. | Submittername, address,contact | Qualigen, Incorporated2042 Corte del NogalCarlsbad, 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 andunassayed) | ||
| 3. | Predicatedevice | FastPack® Controls | |
| 4. | Devicedescription | FastPack® PSA Method Verification KitThe FastPack® Total PSA Method Verification kit components are in liquidform, in vials, from which the user can directly remove sample. They areformulated at three (3) levels packaged together as a kit. | |
| 5. | Intended use | The FastPack® Total PSA Method Verification Kit consists of assayedquality control materials for verification of the calibration and reportablerange of the FastPack® Total PSA Immunoassay to meet CLIArequirements. |
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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 PSAMethod Verification Kit | |
| Intended Use | Assayed quality controlmaterials for the verificationof the accuracy andprecision of the FastPack®Analyzer system when usedfor the quantitativedetermination of PSA inhuman serum or plasma. | Assayed quality controlmaterials for theverification of thecalibration and reportablerange of the FastPack®Total PSA Immunoassayto meet CLIArequirements. |
| 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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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
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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
Page 1 of 1
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§ 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.