(153 days)
The FastPack ® Free T4 Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of free thyroxine (FT4) in human serum. The FastPack ® Free T4 Immunoassay is designed for use with the FastPack ® Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of thyroid dysfunction.
The FastPack® Free T4 Immunoassay is a competitive chemiluminescense assay.
● Primary incubation: Sample, calibrator, or control (100 µL) is added to the antibody solution (100 µL) to start the sequence. The reaction time is 10 seconds at 37° C.
- . Secondary incubation: The initial reaction mixture (200 uL) is transferred to the magnetic particles with bound testosterone and competition between the sample testosterone and the beads continues for an additional 2.5 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® Analyzer System at 37° C.
The provided text describes the FastPack® Free T4 Immunoassay on the FastPack® Analyzer System. Here's a breakdown of the acceptance criteria and the study information:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device's performance characteristics in a tabular format. Instead, it presents the performance data of the FastPack® Free T4 Immunoassay and compares it directly to a predicate device (Abbott IMx® Free T4). The implication is that the performance shown met the internal criteria or was considered substantially equivalent to the predicate device.
Here's a table summarizing the reported device performance, with the predicate device's performance for comparison, which implicitly sets a benchmark for acceptance:
| Feature | FastPack® Free T4 | Abbott IMx® Free T4 (Predicate) |
|---|---|---|
| Precision (Between Run) | ||
| Level 1: Mean (ng/dL) / %CV | 1.43 / 7.4 | 1.18 / 4.47 |
| Level 2: Mean (ng/dL) / %CV | 3.51 / 6.2 | 3.23 / 5.59 |
| Precision (Between Analyzer) | ||
| Level 1: Mean (ng/dL) / %CV | 1.43 / 2.8 | 1.18 / 3.80 |
| Level 2: Mean (ng/dL) / %CV | 3.51 / 1.8 | 3.23 / 4.79 |
| Precision (Between Reagent Lot) | ||
| Level 1: Mean (ng/dL) / %CV | 1.43 / 11.1 | Not provided |
| Level 2: Mean (ng/dL) / %CV | 3.51 / 4.8 | Not provided |
| Analytical Sensitivity | 0.4 ng T4/dL | 0.4 ng T4/dL |
| Method Comparison vs. Abbott IMx Free T4 | ||
| Equation | y = 1.07x - 0.17 | - |
| Correlation Coefficient (r) | 0.95 | - |
| Interfering Substances (No interference up to) | ||
| Bilirubin | 40 mg/dL | 20 mg/dL |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Triglycerides | 1000 mg/dL | 1200 mg/dL |
| Specificity (L-T3) | ≤ 0.9% | ≤ 0.5% |
Note: The acceptance criteria for the FastPack® device are implicitly demonstrated by its performance being comparable or superior to the predicate device in key metrics, as required for 510(k) clearance based on substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size for Method Comparison: n = 131 samples were used for the method comparison study against the Abbott IMx Free T4.
- Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective. It is implied to be clinical samples used for assay validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to this type of device. The ground truth for an immunoassay like this is established by the reference method (in this case, the predicate device Abbott IMx Free T4) and other analytical validation methods (precision, sensitivity, interference). It does not involve human expert interpretation of images or other subjective data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable to this type of device. Adjudication methods are typically used when there are subjective interpretations being made by humans (e.g., in medical image analysis). For an in vitro diagnostic immunoassay, the "adjudication" is inherent in the analytical process and result generation, verified against established analytical standards and predicate device performance.
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 information is not applicable to this type of device. An immunoassay is an automated analytical test, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable in the context of an AI algorithm. However, the FastPack® Free T4 Immunoassay itself is a standalone diagnostic test in the sense that the system provides a quantitative result without continuous human intervention in the result generation process once the sample is loaded and the test initiated. The performance characteristics described (precision, sensitivity, method comparison) are all "standalone" performance metrics of the device as an automated system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for this device's performance is established by:
- Reference Intervals/Ranges: The stated assay range of 0.4 to 6 ng/dL for Free T4, which aligns with clinical understanding of normal/abnormal levels.
- Comparison to a Legally Marketed Predicate Device: The Abbott IMx Free T4 system served as the primary comparative ground truth, with performance metrics (correlation coefficient, regression equation) indicating agreement.
- Analytical Validation: Internal studies demonstrating precision, analytical sensitivity, and non-interference from common substances.
8. The sample size for the training set
- This information is not explicitly provided in the document. For an immunoassay, there isn't a "training set" in the machine learning sense. Instead, development and optimization would involve numerous samples during method development, reagent optimization, and calibration curve generation. The 131 samples mentioned were specifically for the method comparison study, which is part of validation.
9. How the ground truth for the training set was established
- As mentioned above, there isn't a "training set" in the AI sense. For an immunoassay, the "ground truth" for developing and calibrating the system would be established through a combination of:
- Known concentration samples: Using gravimetrically prepared or independently validated samples with known Free T4 concentrations to develop the assay and establish its dose-response curve.
- Reference methods: Comparing early versions of the assay to existing, validated laboratory reference methods.
- Clinical samples: Using a large panel of clinical samples with clinically confirmed diagnoses or results from established methods to fine-tune the assay's performance and ensure accurate measurement across the intended analytical range.
- Calibrators: The FastPack® Testo/Free T4 Calibrator is used to calibrate the system, implying that these calibrators have assigned values based on rigorous analytical standards, acting as a form of ground truth for instrument calibration.
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510(k) Summary K030329
FastPack® Free T4 Immunoassay on the FastPack® Analyzer 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. | Submittername, address,contact | Qualigen, Incorporated2042 Corte del NogalCarlsbad, CA 92009 | ||
|---|---|---|---|---|
| Telephone:Fax: | (760) 918-9165(760) 918-9127 | |||
| Contact Person: | Dorothy Deinzer | |||
| Date Prepared: | January 28, 2003 | |||
| 2. | Device name | Proprietary name: | FastPack® Free T4 Immunoassayon the FastPack® Analyzer System | |
| Common name: | Chemiluminescense assay for the determination ofFree T4 | |||
| Classification Name: | Quantitative Determination of Free T4 in HumanSerum | |||
| 3. | Predicatedevice | Abbott Laboratories IMx Free T4 (K902834) | ||
| 4. | Devicedescription | FastPack® Free T4 Immunoassay Reagents | ||
| The FastPack® Free T4 Immunoassay is a competitive chemiluminescenseassay. | ||||
| ● Primary incubation: Sample, calibrator, or control (100 µL) is addedto the antibody solution (100 µL) to start the sequence. The reactiontime is 10 seconds at 37° C. |
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-
. Secondary incubation: The initial reaction mixture (200 uL) is transferred to the magnetic particles with bound testosterone and competition between the sample testosterone and the beads continues for an additional 2.5 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® Analyzer System at 37° C.
-
Intended use న. The FastPack® Free Ta Immunoassay is a paramagnetic particle immunoassay intended for the in vitro quantitative determination of Free T4 in human serum. The FastPack® Free T4 Immunoassay is designed for use with the FastPack® Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of thyroid dysfunction.
-
- Comparison to The following tables compare the FastPack® Immunoassay System Predicate Device for Free T4 with the Abbott Laboratories Free T4 method.
| Feature | FastPack® System | Abbott IMx® System |
|---|---|---|
| Intended Use | For the quantitativemeasurement of freethyroxine in human serum. | For the quantitativemeasurement of free thyroxine(FT4) in human serum andheparinized plasma. |
| AssayMethodology: | Competitive immunoassay | Competitive 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: | Serum | Serum, Heparinized Plasma |
| Detector: | Photomultiplier Tube(PMT) | Photomultiplier Tube (PMT) |
| Label | Alkaline Phosphatase | Alkaline Phosphatase |
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| Sample Volume | 100 µL | 150 µL |
|---|---|---|
| Assay Range | 0.4 to 6 ng/dL | 0.4 to 6 ng/dL |
| InstrumentRequired | FastPack® AnalyzerSystem | Abbott IMx® System |
| Control Levels | 2(not supplied) | 3 |
| Antibody | Monoclonal | Polyclonal |
| Competingcomponent | T3 covalently coupled toparamagnetic particles | T3-Alkaline PhosphataseConjugate |
| Solid Phase | Paramagnetic particles | Latex Microparticles |
| Substrate | ImmuGlow™ (Indoxyl -3-phosphate and lucigenin) | 4-MethylumbelliferylPhosphate |
| Detection | Chemiluminescense | Fluorescence |
| Calibration | Factory generated mastercurve with single-levelcalibration adjustmentevery 14 days. | Full calibration curve (sixstandards) with change inreagents. |
| Throughput | Single Sample | Batch |
| Time to Result | 7 minutes | 45 minutes to first result |
| ReagentsSupplied as | Box of 50 disposable selfcontained reagent packs | Free T4 Reagent Pack for 100test, 6 vials of calibrator |
Performance Characteristics:
| Feature | FastPack® Free T4 | Abbott IMx® Free T4 | ||||
|---|---|---|---|---|---|---|
| Precision | Meanng/dL | %CV | Meanng/dL | %CV | ||
| Between Run | Run to Run | |||||
| 1 | 1.43 | 7.4 | 1 | 1.18 | 4.47 | |
| 2 | 3.51 | 6.2 | 2 | 3.23 | 5.59 | |
| Between Analyzer | Between Run | |||||
| 1 | 1.43 | 2.8 | 1 | 1.18 | 3.80 | |
| 2 | 3.51 | 1.8 | 2 | 3.23 | 4.79 | |
| Between Reagent Lot | ||||||
| 1 | 1.43 | 11.1 | ||||
| 2 | 3.51 | 4.8 | ||||
| AnalyticalSensitivity | 0.4 ng T4/dL | 0.4 ng T4/dL | ||||
| MethodComparison | versus Abbott IMx Free T4: | |||||
| n = 131 | ||||||
| Range of values (IMx): 0.61 to 5.52 ng T4/dL | ||||||
| Range of values (FastPack): 0.52 to 5.93 ng T4/dL | ||||||
| y = 1.07x - 0.17 | ||||||
| r = 0.95 |
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Qualigen, Incorporated
| InterferingSubstances | No interference up to: | No interference up to: |
|---|---|---|
| Bilirubin | 40 mg/dL | 20 mg/dL |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Triglycerides | 1000 mg/dL | 1200 mg/dL |
| Specificity | L-T3≤ 0.9% | L-T3≤ 0.5% |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 2098 Gaither Road Rockville MC 20850
Ms. Dorothy Deinzer Vice President Quality and Regulatory Affairs Qualigen, Inc. 2042 Corte Del Nogal Carlsbad, CA 92009
'JUL 0 3 2003
K030329 Re: Trade/Device Name: FastPack® Free T4 Immunoassay FastPack® Testo/Free T4 Calibrator Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system : Regulatory Class: Class II Product Code: CEC; JIX Dated: May 23, 2003 Received: May 28, 2003
Dear Ms. Deinzer:
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Attachment 4
Indications for Use Statement
| 510(k) Number | K030329 |
|---|---|
| Device Name | FastPack ® Free T4 Immunoassay |
| Indications for Use | The FastPack ® Free T4 Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of free thyroxine (FT4) in human serum. The FastPack ® Free T4 Immunoassay is designed for use with the FastPack ® Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of thyroid dysfunction. |
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K030329 |
|---|---|
| -------- | --------- |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
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Page 2 of 2
Indications for Use Statement
| 510(k) Number | K030329 |
|---|---|
| Device Name | FastPack® Testo/Free T4 Calibrator |
| Indications for Use | The FastPack® Testo/Free T4 Calibrator is intended to calibrate the FastPack® Analyzer system when used for the quantitative determination of Total Testosterone or Free T4 in human serum |
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K030329
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.