(31 days)
K99/692
K99/692 Chiron Diagnostics ACS: 180 FT3 Immunoassay
No
The device description details a competitive immunoassay using chemiluminescent technology and automated steps for sample processing and measurement. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis focuses on chemical reactions and automated physical processes.
No
This device is for the quantitative determination of free triiodothyronine (FT3) in serum to assist in the diagnosis and treatment of thyroid diseases, making it a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements obtained by this test "are used in the diagnosis and treatment of thyroid diseases."
No
The device description clearly outlines a competitive immunoassay using direct, chemiluminescent technology, involving physical steps like dispensing samples and reagents, incubation, separation, aspiration, washing, and initiating a chemical reaction. This indicates a hardware-based system for performing the assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the quantitative determination of free triiodothyronine (FT3) in serum... Measurements obtained by this test are used in the diagnosis and treatment of thyroid diseases." This clearly indicates the device is used to examine specimens derived from the human body (serum) to provide information for diagnostic purposes.
- Device Description: The description details a "competitive immunoassay using direct, chemiluminescent technology" that analyzes a sample (serum) to determine the concentration of FT3. This is a typical method used in in vitro diagnostic testing.
- Performance Studies: The document includes sections on "Expected Results," "Sensitivity and Assay Reportable Range," "Method Comparison," and "Precision," which are standard components of performance evaluations for IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with the name "Chiron Diagnostics ACS: 180 FT3 Immunoassay" further confirms that this device is being compared to an existing IVD device for regulatory purposes.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative determination of free triiodothyronine (FT3) in serum using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.
Measurements obtained by this test are used in the diagnosis and treatment of thyroid diseases.
Product codes
CDP
Device Description
Trilodothyronine (3,5,3'-L-triiodothyronine, T3) is a hormone synthesized and secreted from the thyroid gland, and formed by peripheral deiodination of thyroxine (T4). T3 and T4 are secreted into the circulation in response to thyroid stimulating hormone (TSH) and play an important role in requlating metabolism
In the circulation, 99.7% of T3 is reversibly bound to transport proteins, primarily thyroxinebinding globulin (TBG) and to a lesser extent albumin and prealbumin. The remaining T3 does not bind to transport proteins, but is free in the circulation. This unbound fraction of the total T3 concentration is free triiodothyronine (free T3, FT3). Unbound T3 is metabolically active.
Free T3 levels correlate with T3 secretion and metabolism. In hypothyroidism and hyperthyroidism, free T3 levels parallel changes in total T3 levels. However, measuring free T3 is useful when altered levels of total T3 occur due to changes in T3 binding proteins, especially TBG. TBG levels remain relatively constant in healthy individuals, but certain conditions such as normal pregnancy and steroid therapy can alter these levels. In these conditions, free T3 levels are unchanged, while total T3 levels parallel the changes in TBG.
The Chiron Diagnostics ACS:180 FT3 assay is a competitive immunoassay using direct, chemiluminescent technology. FT3 in the sample competes with a T3 analog, which is covalently coupled to paramagnetic particles in the Solid Phase, for a limited amount of a combination of acridinium ester-labeled monoclonal mouse anti-T3 antibodies in the Lite Reagent.
The system automatically performs the following steps:
- dispenses 50 µL of sample into a cuvette ●
- dispenses 100 µL of Lite Reagent and incubates for 5.0 minutes at 37 C ●
- dispenses 450 µL of Solid Phase and incubates for 2.5 minutes at 37 C .
- separates, aspirates, and washes the cuvettes with reagent water ●
- dispenses 300 µL each of Reagent 1 and Reagent 2 to initiate the chemiluminescent . reaction
- . reports the results according to the selected option, as described in the system operating instructions or in the online help system
An inverse relationship exists between the amount of FT3 present in the patient sample and the amount of relative light units (RLUs) detected by the system.
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
Expected Results: To determine the ACS:180 FT3 reference range, a study was performed on samples from 594 apparently healthy adult individuals. Ninety-five percent of the FT3 values for these individuals fell in the range of 2.3 to 4.2 pg/mL (3.5 to 6.5 pmol/L). A study of 185 apparently healthy individuals was performed and found to have a normal range concurrent with the above claim of a normal range spanning 2.3 to 4.2 pg/mL (3.5 to 6.5 pmol/L).
Sensitivity and Assay Reportable Range: The ACS:180 FT3 assay measures FT3 concentrations up to 20 pg/mL (30.8 pmol/L) with a minimum detectable concentration of 0.5 pg/mL (0.8 pmo//L). Analytical sensitivity is defined as the concentration of FT3 that corresponds to the RLUs that are two standard deviations less than the mean RLUs of multiple replicate determinations of the FT3 zero standard with multiple lots of reagents and across multiple systems.
Method Comparison: For 359 samples in the range of 0.68 to 17.9 pg/mL (1.05 to 27.6 pmol/L), the relationship between the ACS:180 FT3 assay and an alternate method is described by the equation: ACS:180 FT3 = 0.93 (alternate method) + 0.319 pg/mL. Correlation coefficient (r) = 0.99.
Precision: Three samples were assayed 6 times in each of 12 runs, on 4 systems.
Results:
- Mean (pg/mL): 2.125, Mean (pmol/L): 3.272, Within-run % CV: 2.029, Total % CV: 2.878
- Mean (pg/mL): 4.592, Mean (pmol/L): 7.072, Within-run % CV: 1.473, Total % CV: 1.649
- Mean (pg/mL): 9.861, Mean (pmol/L): 15.186, Within-run % CV: 1.359, Total % CV: 2.465
Key Metrics
Sensitivity: minimum detectable concentration of 0.5 pg/mL (0.8 pmo//L).
Correlation coefficient (r) = 0.99 (method comparison)
Precision: Total % CV ranged from 1.649% to 2.878%
Predicate Device(s)
K99/692 Chiron Diagnostics ACS: 180 FT3 Immunoassay
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1710 Total triiodothyronine test system.
(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Summary of Safety and Effectiveness JUN 18 1999
K99/692
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitters Information
| Contact person: | William J. Pignato
Director of Regulatory Affairs |
|-----------------|-------------------------------------------------------------------------|
| Address: | Chiron Diagnostics Corporation
63 North Street
Medfield, MA 02052 |
| Phone: | (508) 359-3825 |
| Fax | (508) 359-3356 |
| e-mail | william.pignato.b@bayer.com |
Date Summary Prepared: April 30, 1999
2. Device Information
| Proprietary Name: | Chiron Diagnostics ACS: 180 FT3 |
|---|---|
| Common Name: | Free triiodothyronine test system |
| Device Classification: | Class II |
3. Predicate Device Information
| Name: | Chiron Diagnostics ACS: 180 FT3 Immunoassay |
|---|---|
| Manufacturer: | Chiron Diagnostics Corporation |
4. Device Description
Trilodothyronine (3,5,3'-L-triiodothyronine, T3) is a hormone synthesized and secreted from the thyroid gland, and formed by peripheral deiodination of thyroxine (T4). T3 and T4 are secreted into the circulation in response to thyroid stimulating hormone (TSH) and play an important role in requlating metabolism
In the circulation, 99.7% of T3 is reversibly bound to transport proteins, primarily thyroxinebinding globulin (TBG) and to a lesser extent albumin and prealbumin. The remaining T3 does not bind to transport proteins, but is free in the circulation. This unbound fraction of the total T3 concentration is free triiodothyronine (free T3, FT3). Unbound T3 is metabolically active.
Free T3 levels correlate with T3 secretion and metabolism. In hypothyroidism and hyperthyroidism, free T3 levels parallel changes in total T3 levels. However, measuring free T3 is useful when altered levels of total T3 occur due to changes in T3 binding proteins, especially TBG. TBG levels remain relatively constant in healthy individuals, but certain conditions such as normal pregnancy and steroid therapy can alter these levels. In these conditions, free T3 levels are unchanged, while total T3 levels parallel the changes in TBG.
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5. Statement of Intended Use
For the quantitative determination of free triiodothyronine (FT3) in serum using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.
6. Summary of Technological Characteristics
The Chiron Diagnostics ACS:180 FT3 assay is a competitive immunoassay using direct, chemiluminescent technology. FT3 in the sample competes with a T3 analog, which is covalently coupled to paramagnetic particles in the Solid Phase, for a limited amount of a combination of acridinium ester-labeled monoclonal mouse anti-T3 antibodies in the Lite Reagent.
The system automatically performs the following steps:
- dispenses 50 µL of sample into a cuvette ●
- dispenses 100 µL of Lite Reagent and incubates for 5.0 minutes at 37 C ●
- dispenses 450 µL of Solid Phase and incubates for 2.5 minutes at 37 C .
- separates, aspirates, and washes the cuvettes with reagent water ●
- dispenses 300 µL each of Reagent 1 and Reagent 2 to initiate the chemiluminescent . reaction
- . reports the results according to the selected option, as described in the system operating instructions or in the online help system
An inverse relationship exists between the amount of FT3 present in the patient sample and the amount of relative light units (RLUs) detected by the system.
6. Performance Characteristics
Expected Results
To determine the ACS:180 FT3 reference range, a study was performed on samples from 594 apparently healthy adult individuals. Ninety-five percent of the FT3 values for these individuals fell in the range of 2.3 to 4.2 pg/mL (3.5 to 6.5 pmol/L). A study of 185 apparently healthy individuals was performed and found to have a normal range concurrent with the above claim of a normal range spanning 2.3 to 4.2 pg/mL (3.5 to 6.5 pmol/L).
As with all diagnostic assays, each laboratory should determine its own reference range(s) for the diagnostic evaluation of patient results.
Sensitivity and Assay Reportable Range
The ACS:180 FT3 assay measures FT3 concentrations up to 20 pg/mL (30.8 pmol/L) with a minimum detectable concentration of 0.5 pg/mL (0.8 pmo//L). Analytical sensitivity is defined as the concentration of FT3 that corresponds to the RLUs that are two standard deviations less than the mean RLUs of multiple replicate determinations of the FT3 zero standard with multiple lots of reagents and across multiple systems.
2
Method Comparison
For 359 samples in the range of 0.68 to 17.9 pg/mL (1.05 to 27.6 pmol/L), the relationship between the ACS:180 FT3 assay and an alternate method is described by the equation: ACS:180 FT3 = 0.93 (alternate method) + 0.319 pg/mL Correlation coefficient (r) = 0.99
Precision
Three samples were assayed 6 times in each of 12 runs, on 4 systems. The following results were obtained:
| Mean (pg/mL) | Mean (pmol/L) | Within-run % CV | Total % CV |
|---|---|---|---|
| 2.125 | 3.272 | 2.029 | 2.878 |
| 4.592 | 7.072 | 1.473 | 1.649 |
| 9.861 | 15.186 | 1.359 | 2.465 |
:
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Public Health Service
JUN 18 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. William J. Pignato Director of Regulatory Affairs Chiron Diagnostics Corporation 63 North Street Medfield, Maine 02052-1688
K991692 Re:
Trade Name: Chiron Diagnostics ACS:180® FT3 Assay Regulatory Class: II Product Code: CDP Dated: May 10, 1999 Received: May 18, 1999
Dear Mr. Pignato:
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 (OS) 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 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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✓ | OR | Over-The-Counter Use |
|----------------------|------------------------------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | (Optional Format) |