(182 days)
The FastPack™ PSA Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The FastPack™ PSA Immunoassay is indicated as an aid in the management of patients with prostate cancer. The FastPack™ PSA Immunoassay is designed for use with the FastPack™ Analyzer System.
The FastPack™ PSA Immunoassay is a two-site chemiluminescence assay. The FastPack™ Analyzer System is a compact chemiluminuescent immuoassay system consisting of four components: FastPack™ (Reagent Pack), FastPack™ Sample Filler, FastPack™ Analyzer, and Pressure/Power Supply. The FastPack™ is a small plastic package containing pre-measured reagents. The FastPack™ Sample Filler delivers a quantified sample. The FastPack™ Analyzer performs the assay by automatically mixing and moving the sample and reagents within the pack using pressure pads and a magnet. Temperature control is achieved by heating metal plates.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the FastPack™ PSA Immunoassay:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a formal table format with pass/fail thresholds. However, it presents the "Performance Characteristics" of the FastPack™ PSA against the predicate device (Abbott IMx® PSA). We can infer that the comparable performance to the predicate device serves as an implicit acceptance criterion for substantial equivalence.
| Feature | Implicit Acceptance Criteria (Comparable to Predicate Device) | FastPack™ PSA Performance Reported |
|---|---|---|
| Precision (Between Run) | Should be comparable to Abbott IMx® PSA Intra-assay | Low (0.75 ng/mL): 13.1% |
| Med (2.94 ng/mL): 11.2% | ||
| High (23.41 ng/mL): 9.4% | ||
| Precision (Between Analyzer) | Should be comparable to Abbott IMx® PSA Inter-assay | Low (0.75 ng/mL): 6.2% |
| Med (2.94 ng/mL): 3.7% | ||
| High (23.41 ng/mL): 1.1% | ||
| Precision (Between Reagent Lot) | Not directly comparable to predicate's reported Inter-assay categories, but low variability is expected. | Low (0.75 ng/mL): 1.7% |
| Med (2.94 ng/mL): 5.0% | ||
| High (23.41 ng/mL): 1.4% | ||
| Analytical Sensitivity | Should be comparable to or better than Abbott IMx® PSA | 0.04 ng PSA/mL |
| Spike Recovery | Should be comparable to Abbott IMx® PSA | 96 to 107% |
| Dilution Recovery | Not explicitly stated for predicate; demonstrating recovery is an expectation. | 94 to 120% |
| Method Comparison | Strong correlation (high r²) and agreement (slope close to 1, intercept close to 0) with Abbott IMx® PSA. | n = 110 |
| Range (Abbott): 0 to 51.6 ng PSA/mL | ||
| Range (FastPack): 0 to 57.0 ng PSA/mL | ||
| y = 0.971x - 0.2367 (Deming) | ||
| r² = 0.984 (Spearman) | ||
| s²_slope = 0.000403 | ||
| s²_intercept = 0.111306 | ||
| Interfering Substances | No significant interference at or above levels comparable to predicate. | Bilirubin: No interference up to 49 mg/dL (better than predicate) |
| Hemoglobin: 600 mg/dL | ||
| IgG: 1900 mg/dL | ||
| PAP: 1000 ng/mL | ||
| HAS: Interference found at 3 g/dL | ||
| Triglycerides: 3000 mg/dL | ||
| Cyclophosphamide: 700 µg/mL | ||
| DES: 1 µg/mL | ||
| Doxorubicin HCl: 16 µg/mL | ||
| Methotrexate: 8 µg/mL | ||
| Megestrol Acetate: 90 µg/mL | ||
| Flutamide: 10 µg/mL | ||
| Lupron: 100 µg/mL | ||
| High Dose Hook Effect | Absence of hook effect up to clinically relevant concentrations. | No high dose hook effect up to 500 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance
For the Method Comparison study (which serves as a key test set for comparing with the predicate):
- Sample Size: n = 110 samples.
- Data Provenance: The document does not specify the country of origin. It also does not explicitly state if the data was retrospective or prospective, but clinical method comparison studies typically use prospectively collected or banked samples representing real-world conditions.
For Precision studies, specific sample sizes beyond the general levels (low, medium, high) are not detailed. Similarly for Interfering Substances, specific sample sizes per substance are not given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For an immunoassay like this, the "ground truth" for the test set (e.g., the PSA values) would typically be established by the predicate device's measurement or a reference method. No human experts are involved in establishing the "ground truth" for a quantitative analyte measurement itself, as it's a direct biochemical measurement.
4. Adjudication Method for the Test Set
This concept is not applicable to this type of device (quantitative immunoassay). Adjudication usually pertains to subjective assessments, like medical imaging interpretations, where different human readers might have varying opinions that need to be reconciled. For an immunoassay, the "truth" is the measured analyte concentration.
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
This is not applicable. The FastPack™ PSA Immunoassay is a standalone in vitro diagnostic device for quantitative PSA measurement, not an AI-powered image analysis tool or a system involving human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are standalone performance evaluations of the FastPack™ PSA Immunoassay and Analyzer System. The performance characteristics (precision, sensitivity, recovery, method comparison, interference) are measured solely based on the device's output. There is no human interpretation or intervention in the measurement process itself, beyond sample preparation and loading.
7. The Type of Ground Truth Used
For the method comparison study, the Abbott IMx® PSA measurements were used as the reference or "ground truth" for comparison. This is a common practice in 510(k) submissions where a new device is compared to a legally marketed predicate device. For the other performance metrics (precision, sensitivity, recovery, interference, hook effect), the "ground truth" is established by calibrated control materials or spiked samples with known concentrations.
8. The Sample Size for the Training Set
This information is not provided. Immunoassays like this typically do not have a "training set" in the machine learning sense. Instead, they involve extensive R&D and optimization of reagents, reaction conditions, and calibration algorithms, which would use numerous samples, but these are not usually referred to as a "training set" in the context of regulatory submissions for in vitro diagnostics. If any statistical models were used in the instrument's software, the data used to develop those models would be analogous to a training set, but specifics are absent here.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, a "training set" as understood in AI/ML is not explicitly part of this submission. The development and optimization of the assay would involve using well-characterized samples, calibrators, and controls with known PSA concentrations, likely established through a combination of gravimetric/volumetric preparation, reference methods, and validation against established standards.
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994419
JUN 2 8 2000
Attachment 2 Page I of S
510(k) Summary
FastPack™ PSA Immunoassay on the FastPack™ Analyzer System
This summary of 510(k) safety and effectivencss 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 92009 | ||||
|---|---|---|---|---|---|---|
| Telephone: | (760) 918-9165 | |||||
| Fax: | (760) 918-9127 | |||||
| Contact Person: | Vijay K. Mahant, Ph.D. | |||||
| Date Prepared: | June 22, 2000 | |||||
| 2. | Device name | Proprietary name: | FastPackTM PSA Immunoassayon the FastPackTM Analyzer System | |||
| Common name: | Chemiluminescence assay for the determinationof Prostate-Specific Antigen (PSA). | |||||
| Photometer for clinical use. | ||||||
| Classification Name: | Prostate-Specific Antigen (PSA) for Managementof Prostate Cancer | |||||
| 3. | Predicatedevice | Abbott IMx® PSA (P910007) using Abbott IMx® Analyzer (K864319) | ||||
| 4. | Devicedescription | FastPackTM PSA Immunoassay Reagents | ||||
| The FastPackTM PSA Immunoassay is a two-site chemiluminescence assay. | ||||||
| 1st incubation: 5 minutes at 37° C. Sample, control or calibrator [100µL] and PSA antibody solution [100 µL] react to form a sandwichcomplex. |
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Qualigen, Incorporated
510(k) Summary (continued)
Attachment 2 Page 2 of 5
- 240 incubation; 5 minutes at 37° C. Streptavidin-coated paramagnetic ● particle solution is added to the reaction mixture. After the 5-minute incubation, the sandwich complex is bound to the solid phase via the interaction of biotin and streptavidin.
- Removal of unbound materials: The paramagnetic particles are washed . six times with wash buffer [0.2 mL/wash] to remove unbound materials.
- Substrate addition and detection: Chemiluminogenic substrate [175 . uL } is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack™ Analyzer System.
FastPack™ Analyzer System
The FastPack™ Analyzer System is a compact chemiluminuescent immuoassay system. The system consists of four components:
- FastPack™ (Reagent Pack) .
- FastPack™ Sample Filler ●
- FastPack™ Analyzer .
- Pressure/Power Supply ●
The FastPack™ is a small essentially two-dimensional plastic package that contains all the pre-measured reagents, in sealed chambers, necessary to perform the desired test. The pack label contains a barcode with all necessary information required by the analyzer to run the test.
The FastPack™ Sample Filler delivers an accurate quantified sample (100 UL) of sample, calibrator or control for testing.
The FastPack™ Analyzer is designed to receive the FastPack™ and to perform the necessary assay by automatically mixing and moving the sample and reagents within the pack. The sample and reagents are moved from one chamber to another by applying uniform pressure to the compartments by means of pressure pads extended from the analyzer. The analyzer uses a small magnet to hold the paramagnetic particles during the wash phase. During the entire run of the FastPack™, temperature control is achieved by heating metal plates that adjoin the FastPack™.
- ഗ് Intended use The FastPack™ PSA Immunoassay is a paramagnetic particle, chemiluminescence immunoassay intended for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The FastPack™ PSA Immunoassay is indicated as an aid in the management of patients with prostate cancer. The FastPack™ PSA Immunoassay is designed for use with the FastPack™ Analyzer System.
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Attachment 2 Page 3 of 5
The FastPack™ PSA Immunoassay on the FastPack™ Analyzer System is Comparison to 6. predicate substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the device currently marketed Abbott IMx® PSA on the Abbott IMx® Analyzer.
The following tables compare the FastPack™ Immunoassay System for PSA with the Abbott IMx® System for PSA:
Similarines:
.
| • Assay Methodology: | Sandwich immunoassay |
|---|---|
| • Sample Type: | Serum |
| • Storage Condition: | 2-8 °C |
| • Label | Alkaline Phosphatase |
| • Detector: | Photomultiplier Tube (PMT) |
| • Data Analysis | Internal data reduction via microcomputer |
| • Temperature Control | Required |
| • Test Processing | Automated |
| Comparison to | Differences: | |||||
|---|---|---|---|---|---|---|
| predicate | Feature | FastPack™ PSA | Abbott IMx® PSA | |||
| device(continued) | Intended Use | For the in vitroquantitative determinationof PSA in human serum.It is indicated as an aid inthe management ofpatients with prostatecancer. | As an aid in themanagement of prostatecancer patients. | |||
| Sample Volume | 100 ul | 150 UL | ||||
| Assay Range | 0 to 50 ng/mL | 0 to 100 ng/mL | ||||
| InstrumentRequired | FastPack™ AnalyzerSystem | Abbott IMx® Analyzer | ||||
| Control Levels | 2 | 3 | ||||
| CalibrationLevels | 5 | 6 | ||||
| CaptureAntibody | Monoclonal | Polyclonal | ||||
| Solid-phase | Streptavidin-coatedparamagnetic particles | Monoclonal Anti-PSAcoated microparticles | ||||
| Substrate | ImmuGlowTN (Indoxyl -3-phosphate and lucigenin) | 4-MethylumbelliferylPhosphate |
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510(k) Summary (continued)
Qualigen, Incorporated
Attachment 2 Page 4 of 5
| Detection | Chemiluminescence | Fluorescence |
|---|---|---|
| Calibration | Factory generated mastercurve with daily two-levelcalibration adjustment | Full calibration curveevery 4 weeks |
| Throughput | Single Sample | 24 Samples |
| Time to Result | 30 minutes | 40 minutes |
| SampleCartridge | All reagent included | Reagent pack and washseparate |
Performance Characteristics:
| Feature | FastPack™ PSA | Abbott IMx® PSA |
|---|---|---|
| Precision | ng/mL PSA | ng/mL PSA |
| Between Run | Intra-assay | |
| Low (0.75) 13.1% | Low (4.6) 3.5% | |
| Med (2.94) 11.2% | Med (15.6) 3.3% | |
| High (23.41) 9.4% | High (60.2) 3.1% | |
| Between Analyzer | Inter-assay | |
| Low (0.75) 6.2% | Low (4.6) 4.7% | |
| Med (2.94) 3.7% | Med (15.6) 4.5% | |
| High (23.41) 1.1% | High (60.2) 5.3% | |
| Between Reagent Lot | ||
| Low (0.75) 1.7% | ||
| Med (2.94) 5.0% | ||
| High (23.41) 1.4% | ||
| AnalyticalSensitivity | 0.04 ng PSA/mL | 0.1 ng PSA/mL |
| Spike Recovery | 96 to 107% | 91 to 103% |
| DilutionRecoveryMethodComparison | 94 to 120% | Not reported |
| versus Abbott IMx® PSA: | ||
| n = 110 | ||
| Range of values (Abbott): 0 to 51.6 ng PSA/mL | ||
| Range of values (FastPack): 0 to 57.0 ng PSA/mL | ||
| y = $0.971x - 0.2367$ (Deming) | ||
| $r^2$ = 0.984 (Spearman) | ||
| $s^2_{slope}$ = 0.000403 | ||
| $s^2_{intercept}$ = 0.111306 |
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Qualigen, Incorporated
510(k) Summary (continued)
Attachment 2
Page 5 of 5
| InterferingSubstances | ||
|---|---|---|
| Bilirubin | No interference up to:49 mg/dL | No interference up to:25 mg/dL |
| Hemoglobin | 600 mg/dL | 600 mg/dL |
| IgG | 1900 mg/dL | 250-2900 mg/dL |
| PAP | 1000 ng/mL | 1000 ng/mL |
| HSA | Interference found at 3 g/dL | 3-13 g/dL |
| Triglycerides | 3000 mg/dL | 3000 mg/dL |
| Cyclophosphamide | 700 µg/mL | 700 µg/mL |
| DES | 1 µg/mL | 2 µg/mL |
| Doxorubicin HCl | 16 µg/mL | 16 µg/mL |
| Methotrexate | 8 µg/mL | 30 µg/mL |
| Megestrol Acetate | 90 µg/mL | 90 µg/mL |
| Flutamide | 10 µg/mL | 10 µg/mL |
| Lupron | 100 µg/mL | 100 µg/mL |
| High Dose HookEffect | No high dose hook effectup to 500 ng/mL | Not reported |
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
JUN 2 8 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Vijay Mahant, Ph.D. Vice President, Research and Development Qualigen, Inc. 2042 Corte del Nogal Carlsbad, California 92009
K994419 Re:
Trade Name: Fastpack™ PSA Immunoassay Product Code: LTJ Regulatory Class: II JJO II Dated: April 25, 2000 Received: May 3, 2000
Dear Dr. Mahant:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin marketing your device to a legally marketed notification. The FD7 midnig of baseian.can vour device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and II you desire specific advices for your as ic devices), please contact the Office of Compliance at additionally 607.10 for m-rire diagnestions on the promotion and advertising of your device, (201) 594-4566. Truditionally, for quice at (301) 594-4639. Also, please note the regulation prease contact the Orneo or Complanes (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibilities and the end the results of (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 1
Indications for Use Statement
| 510(k) Number | K994419 |
|---|---|
| Device Name | FastPack™ PSA Immunoassay and the FastPack™ Analyzer System |
| Indications for Use | The FastPack™ PSA Immunoassay is a paramagnetic particle,chemiluminescence immunoassay for the in vitro quantitativedetermination of prostate-specific antigen (PSA) in human serum. TheFastPack™ PSA Immunoassay is indicated as an aid in the managementof patients with prostate cancer. The FastPack™ PSA Immunoassay isdesigned for use with the FastPack™ Analyzer System. |
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
:
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.