(135 days)
Not Found
No
The summary describes a standard immunoassay technology and system. There is no mention of AI, ML, or any computational methods that would suggest their use in data analysis, interpretation, or system control beyond basic automation.
No
This device is an in vitro diagnostic immunoassay used for the quantitative determination of TSH in human plasma, aiding in the diagnosis of thyroid or pituitary disorders. It does not provide any therapeutic intervention.
Yes
The intended use explicitly states that the measurements are "used in the diagnosis of thyroid or pituitary disorders," which directly indicates its role as a diagnostic device.
No
The device description details a multi-step immunoassay process involving chemical reactions, incubations, washing, and detection of chemiluminescence, which are all hardware-dependent processes. The device is an immunoassay kit intended for use with a specific hardware system (FastPack® System).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "for the in vitro quantitative determination of Thyroid-Stimulating Hormone in human plasma." The term "in vitro" is a key indicator of an IVD.
- Sample Type: The device analyzes "human plasma," which is a biological sample taken from the body, a common characteristic of IVDs.
- Purpose: The measurements are used "in the diagnosis of thyroid or pituitary disorders," indicating a medical purpose for the test results.
- Device Description: The description details a laboratory-based assay process involving chemical reactions and measurement of a biological marker (TSH).
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K942566) is typical for medical devices, including IVDs, undergoing regulatory review.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
JLW, JJX, JIT
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
- FastPack® TSH:
- Between Run: Mean 0.53 µIU/mL (10.9 %CV), 1.54 µIU/mL (7.4 %CV), 12.39 µIU/mL (5.2 %CV)
- Between Analyzer: Mean 0.53 µIU/mL (2.2 %CV), 1.54 µIU/mL (0.5 %CV), 12.39 µIU/mL (1.1 %CV)
- Between Reagent Lot: Mean 0.53 µIU/mL (1.2 %CV), 1.54 µIU/mL (0.3 %CV), 12.39 µIU/mL (4.8 %CV)
- Abbott IMx® hTSH II:
- Run to Run: Mean 0.28 µIU/mL (4.20 %CV), 6.10 µIU/mL (3.42 %CV)
- Between Run: Mean 0.28 µIU/mL (3.44 %CV), 6.10 µIU/mL (3.25 %CV)
Analytical Sensitivity:
- FastPack® TSH: 0.01 µIU/mL
- Abbott IMx® hTSH II: 0.02 µIU/mL
Functional Sensitivity:
- FastPack® TSH: 0.13 µIU/mL
- Abbott IMx® hTSH II: 0.04 µIU/mL
Method Comparison (FastPack® TSH vs. Abbott IMx Ultrasensitive hTSH II):
- n = 93
- Range of values (IMx): 0.00 to 75.00 µIU/mL
- Range of values (FastPack): 0.03 to 64.25 µIU/mL
- y = 0.91 x + 1.26
- r = 0.98
Interfering Substances (No interference up to):
- Bilirubin: FastPack® TSH 40 mg/dL, Abbott IMx® hTSH II 10 mg/dL
- Hemoglobin: FastPack® TSH 1000 mg/dL, Abbott IMx® hTSH II 1000 mg/dL
- Triglycerides: FastPack® TSH 1000 mg/dL, Abbott IMx® hTSH II 1200 mg/dL
Specificity (n.d. = not detected):
- FastPack® TSH: 500 mIU/mL LH n.d., 500 mIU/mL FSH n.d., 200,000 mIU/mL hCG n.d.
- Abbott IMx® hTSH II: 1000 mIU/mL LH n.d., 1000 mIU/mL FSH n.d., 200,000 mIU/mL hCG n.d.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for Analytical Sensitivity and Functional Sensitivity.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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, Incorporated
2042 Corte del Nogal
Carlsbad, CA 92011 |
|----|----------------------------------|------------------------------------------------------------------------|
| | | Telephone: (760) 918-9165
Fax: (760) 918-9127 |
| | | Contact Person: Dorothy Peterson |
| | | Date Prepared: August 15, 2005 |
| 2. | Device name | Proprietary name: FastPack® TSH Immunoassay
on 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) |
1
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.
2
-
- 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 quantitative | |
| measurement of Thyroid- | ||
| Stimulating Hormone | ||
| (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. | For the quantitative | |
| measurement of Thyroid- | ||
| Stimulating Hormone (TSH) | ||
| in human serum and | ||
| heparinized plasma. | ||
| Assay | ||
| Methodology: | Sandwich immunoassay | Sanwich immunoassay |
| Storage | ||
| Condition: | 2-8 °C | 2-8 °C |
| Data Analysis | Internal data reduction via | |
| microcomputer | Internal data reduction via | |
| microcomputer | ||
| Temperature | ||
| Control | 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 |
| Instrument | ||
| Required | 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-Methylumbelliferyl | |
| Phosphate | ||
| Detection | Chemiluminescence | Fluorescence |
| Calibration | Factory generated master | |
| curve with a single level | ||
| calibration adjustment | ||
| every 14 days. | Full calibration curve (six | |
| standards) with change in | ||
| reagents. | ||
| Throughput | Single Sample | Batch |
| Time to Result | 16 minutes | 45 minutes to first result |
| Reagents | ||
| Supplied as | Box of 50 disposable self | |
| contained reagent packs | Reagent Pack for 100 test |
3
Qualigen, Incorporated
Performance Characteristics:
| Feature | FastPack® TSH | Abbott IMx® hTSH II | ||
|---|---|---|---|---|
| Precision | ||||
| Mean | ||||
| µIU/mL | %CV | Mean | ||
| µIU/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 | |||
| Analytical | ||||
| Sensitivity | 0.01 µIU/mL | 0.02 µIU/mL | ||
| Functional | ||||
| Sensitivity | 0.13 µIU/mL | 0.04 µIU/mL | ||
| Method | ||||
| Comparison | versus Abbott IMx Ultrasensitive hTSH II: | |||
| n = 93 | ||||
| Range of values (IMx): 0.00 to 75.00 µIU/mL | ||||
| Range of values (FastPack): 0.03 to 64.25 µIU/mL | ||||
| y = 0.91 x + 1.26 | ||||
| r = 0.98 | ||||
| Interfering | ||||
| Substances | 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. |
4
Qualigen, Incorporated
| Functional
| Sensitivity | 0.13 µIU/mL | 0.04 µIU/mL |
|---|---|---|
| Method | ||
| Comparison | versus Abbott IMx Ultrasensitive hTSH II: |
n = 93
Range of values (IMx): 0.00 to 75.00 µIU/mL
Range of values (FastPack): 0.03 to 64.25 µIU/mL
y = 0.91 x + 1.26
r = 0.98 | |
| Interfering
Substances | 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 | | |
5
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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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
7
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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