(135 days)
The FastPack® TSH Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of Thyroid-Stimulating Hormone in human plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The FastPack® TSH is designed for use with the FastPack® System.
The FastPack® TSH Calibrator is intended to calibrate the FastPack® System when used for the quantitative determination of TSH in human plasma.
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 PSA in human serum and plasma, and TSH in human plasma.
The FastPack® TSH Immunoassay is a competitive chemiluminescence assay.
- . Primary incubation: Sample, calibrator, or control (100 uL) is added to the antibody solution (100 uL) to start the sequence. The reaction time is 10 minutes at 37° C.
- . Sccondary incubation: The initial reaction mixture (200 µL) is transferred to the magnetic particles and is incubated an additional 2 minutes at 37° C.
- . Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials.
- Substrate addition and detection: Chemiluminogenic substrate [140 . uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® System at 37° C.
- The FastPack® TSH Immunoassay is a paramagnetic particle immunoassay intended for the in vitro quantitative determination of TSH in human plasma.
Here's a summary describing the acceptance criteria and the study outcomes for the FastPack® TSH Immunoassay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) document compares the FastPack® TSH Immunoassay to a predicate device (Abbott Laboratories IMx Ultrasensitive hTSH II) across several performance characteristics. While explicit "acceptance criteria" are not listed as pass/fail thresholds, the comparison serves as the basis for demonstrating substantial equivalence. The reported performance of the FastPack® TSH Immunoassay is presented alongside the predicate device's performance for direct comparison.
| Feature | Acceptance Criteria (Implied by Predicate) | FastPack® TSH Immunoassay Performance |
|---|---|---|
| Precision | Comparable %CVs to predicate device across different TSH levels (e.g., Run to Run for predicate vs. Between Run for FastPack) | Between Run:0.53 µIU/mL: 10.9% CV1.54 µIU/mL: 7.4% CV12.39 µIU/mL: 5.2% CVBetween Analyzer:0.53 µIU/mL: 2.2% CV1.54 µIU/mL: 0.5% CV12.39 µIU/mL: 1.1% CVBetween Reagent Lot:0.53 µIU/mL: 1.2% CV1.54 µIU/mL: 0.3% CV12.39 µIU/mL: 4.8% CV |
| Analytical Sensitivity | Comparable to predicate device (0.02 µIU/mL) | 0.01 µIU/mL |
| Functional Sensitivity | Comparable to predicate device (0.04 µIU/mL) | 0.13 µIU/mL |
| Method Comparison | High correlation (r) and reasonable linear relationship (y=mx+b) to predicate device | n = 93Range of values (IMx): 0.00 to 75.00 µIU/mLRange of values (FastPack): 0.03 to 64.25 µIU/mLy = 0.91 x + 1.26r = 0.98 |
| Interfering Substances | No interference up to levels comparable to predicate device | Bilirubin: No interference up to 40 mg/dLHemoglobin: No interference up to 1000 mg/dLTriglycerides: No interference up to 1000 mg/dL |
| Specificity | n.d. (not detected) for specific interfering hormones at similar or higher concentrations than predicate device | LH: 500 mIU/mL LH (n.d.)FSH: 500 mIU/mL FSH (n.d.)hCG: 200,000 mIU/mL hCG (n.d.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Method Comparison): 93 samples were used for the method comparison study against the predicate device.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. However, given the context of a 510(k) submission for an in vitro diagnostic device, it is typically based on samples collected specifically for the performance evaluation, which could include a mix of retrospective and prospectively collected samples from various sources.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as the FastPack® TSH Immunoassay is an in vitro diagnostic device that measures a quantitative biomarker (TSH levels). The "ground truth" for such devices is established by reference methods or comparison to legally marketed predicate devices, not through expert reading or interpretation of images/data in the same way as medical imaging AI.
4. Adjudication Method for the Test Set
This is not applicable for a quantitative immunoassay device. The performance is assessed by direct comparison of numerical results to a predicate device or reference method, not by expert adjudication of classifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging or interpretive diagnostic AI devices where human readers interpret results, and the AI's impact on reader performance is evaluated. The FastPack® TSH Immunoassay is a laboratory assay with an automated result output.
6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the performance data presented (precision, sensitivity, method comparison, interference, specificity) represents the standalone performance of the FastPack® TSH Immunoassay system. This is the inherent performance of the device and its reagents in generating TSH measurements.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the FastPack® TSH Immunoassay was established by comparison to a legally marketed predicate device, the Abbott Laboratories IMx Ultrasensitive hTSH II. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices when a reference method is not explicitly stated or available. The predicate device's established performance serves as the benchmark.
8. The Sample Size for the Training Set
The document does not report information on a "training set" in the context of machine learning or AI algorithm development. This 510(k) submission describes a traditional immunoassay device, which relies on chemical and biological reactions rather than a trained algorithm in the modern AI sense. Therefore, the concept of a training set as used in AI development is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" is not applicable to this traditional immunoassay device.
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JAN 4 2006
510(k) Summary
FastPack® TSH Immunoassay on the FastPack® System
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, Incorporated2042 Corte del NogalCarlsbad, CA 92011 |
|---|---|---|
| Telephone: (760) 918-9165Fax: (760) 918-9127 | ||
| Contact Person: Dorothy Peterson | ||
| Date Prepared: August 15, 2005 | ||
| 2. | Device name | Proprietary name: FastPack® TSH Immunoassayon the FastPack® System |
| Common name: Chemiluminescence assay for the determination of TSH | ||
| Classification Name: Quantitative Determination of TSH in Human Plasma | ||
| 3. | Predicate device | Abbott Laboratories IMx Ultrasensitive hTSH II (K942566) |
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FastPack® TSH Immunoassay Reagents 4. Device description
The FastPack® TSH Immunoassay is a competitive chemiluminescence assay.
- . Primary incubation: Sample, calibrator, or control (100 uL) is added to the antibody solution (100 uL) to start the sequence. The reaction time is 10 minutes at 37° C.
- . Sccondary incubation: The initial reaction mixture (200 µL) is transferred to the magnetic particles and is incubated an additional 2 minutes at 37° C.
- . Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials.
- Substrate addition and detection: Chemiluminogenic substrate [140 . uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® System at 37° C.
- The FastPack® TSH Immunoassay is a paramagnetic particle immunoassay 5. Intended use intended for the in vitro quantitative determination of TSH in human plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The FastPack® TSH Immunoassay is designed for use with the FastPack® System.
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-
- Comparison to The following tables compare the FastPack® Immunoassay System Predicate Device for TSH with the Abbott Laboratories Ultrasensitive TSH II method.
| Feature | FastPack® System | Abbott IMx® System |
|---|---|---|
| Intended Use | For the quantitativemeasurement of Thyroid-Stimulating Hormone(TSH) in human plasma.The measurements ofthyroid stimulatinghormone (TSH) producedby the anterior pituitaryare used in the diagnosis ofthyroid or pituitarydisorders. | For the quantitativemeasurement of Thyroid-Stimulating Hormone (TSH)in human serum andheparinized plasma. |
| AssayMethodology: | Sandwich immunoassay | Sanwich immunoassay |
| StorageCondition: | 2-8 °C | 2-8 °C |
| Data Analysis | Internal data reduction viamicrocomputer | Internal data reduction viamicrocomputer |
| TemperatureControl | Required | Required |
| Test Processing | Automated | Automated |
| Sample Type: | Plasma | Serum, Heparinized Plasma |
| Detector: | Photomultiplier Tube(PMT) | Photomultiplier Tube (PMT) |
| Label | Alkaline Phosphatase | Alkaline Phosphatase |
| Sample Volume | 100 µL | 150 µL |
| Assay Range | 0 to 100 µIU/mL | 0 to 100 µIU/mL |
| InstrumentRequired | FastPack® System | Abbott IMx® System |
| Control Levels | 2 | 3 |
| Antibody | Monoclonal/Monoclonal | Monoclonal/Polyclonal |
| Solid Phase | Paramagnetic particles | Latex Microparticles |
| Substrate | ImmuGlow™ (Indoxyl -3-phosphate and lucigenin) | 4-MethylumbelliferylPhosphate |
| Detection | Chemiluminescence | Fluorescence |
| Calibration | Factory generated mastercurve with a single levelcalibration adjustmentevery 14 days. | Full calibration curve (sixstandards) with change inreagents. |
| Throughput | Single Sample | Batch |
| Time to Result | 16 minutes | 45 minutes to first result |
| ReagentsSupplied as | Box of 50 disposable selfcontained reagent packs | Reagent Pack for 100 test |
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Qualigen, Incorporated
Performance Characteristics:
| Feature | FastPack® TSH | Abbott IMx® hTSH II | ||
|---|---|---|---|---|
| Precision | ||||
| MeanµIU/mL | %CV | MeanµIU/mL | %CV | |
| Between Run | Run to Run | |||
| 0.53 | 10.9 | 0.28 | 4.20 | |
| 1.54 | 7.4 | 6.10 | 3.42 | |
| 12.39 | 5.2 | |||
| Between Analyzer | Between Run | |||
| 0.53 | 2.2 | 0.28 | 3.44 | |
| 1.54 | 0.5 | 6.10 | 3.25 | |
| 12.39 | 1.1 | |||
| Between Reagent Lot | ||||
| 0.53 | 1.2 | |||
| 1.54 | 0.3 | |||
| 12.39 | 4.8 | |||
| AnalyticalSensitivity | 0.01 µIU/mL | 0.02 µIU/mL | ||
| FunctionalSensitivity | 0.13 µIU/mL | 0.04 µIU/mL | ||
| MethodComparison | versus Abbott IMx Ultrasensitive hTSH II: | |||
| n = 93Range of values (IMx): 0.00 to 75.00 µIU/mLRange of values (FastPack): 0.03 to 64.25 µIU/mLy = 0.91 x + 1.26r = 0.98 | ||||
| InterferingSubstances | No interference up to: | No interference up to: | ||
| Bilirubin | 40 mg/dL | 10 mg/dL | ||
| Hemoglobin | 1000 mg/dL | 1000 mg/dL | ||
| Triglycerides | 1000 mg/dL | 1200 mg/dL | ||
| Specificity | 500 mIU/mL LH | n.d. | 1000 mIU/mL LH | n.d. |
| 500 mIU/mL FSH | n.d. | 1000 mIU/mL FSH | n.d. | |
| n.d. = not detected | 200,000 mIU/mL hCG | n.d. | 200,000 mIU/mL hCG | n.d. |
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Qualigen, Incorporated
| FunctionalSensitivity | 0.13 µIU/mL | 0.04 µIU/mL |
|---|---|---|
| MethodComparison | versus Abbott IMx Ultrasensitive hTSH II:n = 93Range of values (IMx): 0.00 to 75.00 µIU/mLRange of values (FastPack): 0.03 to 64.25 µIU/mLy = 0.91 x + 1.26r = 0.98 | |
| InterferingSubstances | No interference up to: | No interference up to: |
| Bilirubin | 40 mg/dL | 10 mg/dL |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Triglycerides | 1000 mg/dL | 1200 mg/dL |
| Specificity | ||
| 500 mIU/mL LH n.d.500 mIU/mL FSH n.d.200.000 mIU/mL hCG n.d. | 1000 mIU/mL LH n.d.1000 mIU/mL FSH n.d.200.000 mIU/mL hCG n.d | |
| n.d. = not detected |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.
JAN 4 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Dorothy Deinzer Peterson Vice President Ouality Assurance and Regulatory Affairs Qualigen Incorporated 2042 Corte del Nogal Carlsbad, CA 92011
Re: K052301
Trade/Device Name: FastPack® TSH Immunoassay FastPack® TSH Calibrator FastPack® TSH Controls
Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system
Regulatory Class: Class II Product Code: JLW, JJX, JIT
Dated: December 6, 2005
Received: December 14, 2005
Dear Ms. Peterson:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The 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) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Alberto Guts
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number | K052301 |
|---|---|
| Device Name | FastPack® TSH Immunoassay, FastPack® TSH Calibrator, FastPack® Controls |
| Indications for Use | The FastPack® TSH Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of Thyroid-Stimulating Hormone in human plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The FastPack® TSH is designed for use with the FastPack® System.The FastPack® TSH Calibrator is intended to calibrate the FastPack® System when used for the quantitative determination of TSH in human plasma.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 PSA in human serum and plasma, and TSH in human plasma. |
| Prescription Use(Per 21 CFR 801 Subpart D) | X |
| AND/OR Over-The-Counter Use(21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ann Chappe
Division Sign-Off
Office of In Vitro Diagnostic Device
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Evaluation and Safety 510(k)________________________________________________________________________________________________________________________________________________________________________
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§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.