(136 days)
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No
The device description details a standard immunoassay with photometric detection and a calibration curve, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) device used for the quantitative determination of free triiodothyronine (FT3) in human serum and plasma, which aids in the diagnosis and treatment of thyroid diseases. It does not directly treat or prevent a disease; rather, it provides information for diagnostic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "FT3 measurements are used in the diagnosis and treatment of thyroid diseases." This clearly indicates its use for diagnostic purposes.
No
The device description clearly outlines a laboratory-based immunoassay using reagents, tubes, and photometric determination, indicating a hardware-dependent system for in vitro diagnostic testing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the in vitro quantitative determination of free triiodothyronine (FT3) in human serum and plasma." This clearly indicates the device is used to test samples taken from the human body (serum and plasma) outside of the body ("in vitro") to diagnose or monitor a medical condition (thyroid diseases).
- Device Description: The description details a laboratory-based assay using chemical reactions and photometric measurement to determine the concentration of FT3 in a sample. This is characteristic of an in vitro diagnostic test.
- Predicate Device: The mention of a "Predicate Device" which is also a diagnostic product (Diagnostic Products Corp. FT3) further supports that this device falls under the category of IVDs.
The definition of an IVD generally includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or other conditions. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
For the in vitro quantitative determination of free triiodothyronine (FT3) in human serum and plasma.
T3 is biologically the most important thyroid hormone and has been shown to be four to five times more potent than T4. At least 80% of T3 is derived from the deiodination of T4 by the liver and other peripheral tissues rather than from direct secretion by the thyroid.
Since T3 and T4 are poorly soluble in plasma, 70% to 75% are transported by thyroid binding globulin (TBG), a plasma protein. A very low concentration of free T3 (FT3) and free T4 (FT4) exist in equilibrium in plasma with their protein-bound counterparts. However, it is the FT3 and FT4 that are the physiologically active thyroid hormones.. Only these free hormones can bind to receptors on cell surfaces. The cell then converts FT4 to FT3 which can deliver its hormonal message by reacting with DNA.
Circulating FT3 is found in very small quantities (the ratio of FT3 to total T3 is 1:300, or about 0.3% of total serum T3). FT3 and FT4 tend to parallel changes in total T3 and T4, and are not affected by abnormal TBG concentrations.
FT3 measurements are used in the diagnosis and treatment of thyroid diseases. It should be noted that increases and decreases of FT3 and FT4 more accurately reflect hyperthyroidism and hypothyroidism. As such, FT3 is very useful when other tests reflect borderline or conflicting results.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Enzymun FT3 employs a competitive test principle with polyclonal antibodies directed against T3 and with streptavidin tubes .
• 1st Incubation: Sample (100 μl) and a specific anti-T3 antibody are added to the streptavidin tube and all the FT3 present in the sample binds to the anti-T3 antibody-POD conjugate.
• 2nd Incubation: Incubation buffer (biotinylated T# polyhaptens) is added and binds with excess anti-T3 antibody-POD conjugate to the wall of the streptavidin tube.
• In the separation step, serum or plasma FT3-anti-T3 antibody-POD conjugate, excess biotinylated T3 polyhaptens and serum constituents are removed.
• The activity of the POD bound to the tube wall is determined photometrically after the addition of the chromogen and the substrate H2O2 (from sodium perborate). In the indicator reaction, the chromophore formed is a dark green cation whose concentration is indirectly proportional to the FT3 concentration in the sample. Results are determined via a calibration curve.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Diagnostic Products Corp. FT3
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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NOV 2 9 1996 510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 1) Submitter
name, address,
contact | Boehringer Mannheim Corporation
9115 Hague Rd.
Indianapolis, IN 46250
(317) 845-2000 | |
| | Contact Person: John D. Stevens | |
| | Date Prepared: July 12, 1996 | |
| 2) Device name | Proprietary name: Enzymun-Test® FT3 | |
| | Common name: free triiodothyronine test system | |
| 3) Predicate
device | We claim substantial equivalence to the Diagnostic Products Corp. FT3. | |
| 4) Device
Description | The Enzymun FT3 employs a competitive test principle with polyclonal
antibodies directed against T3 and with streptavidin tubes . | |
| | • 1st Incubation: Sample (100 $\mu$ l) and a specific anti-T3 antibody are added
to the streptavidin tube and all the FT3 present in the sample binds to the
anti-T3 antibody-POD conjugate.
• 2nd Incubation: Incubation buffer (biotinylated T# polyhaptens) is added
and binds with excess anti-T3 antibody-POD conjugate to the wall of the
streptavidin tube. | |
| 4) Device
Description,
cont. | • In the separation step, serum or plasma FT3-anti-T3 antibody-POD
conjugate, excess biotinylated T3 polyhaptens and serum constituents are
removed.
• The activity of the POD bound to the tube wall is determined
photometrically after the addition of the chromogen and the substrate H2O2
(from sodium perborate). In the indicator reaction, the chromophore formed
is a dark green cation whose concentration is indirectly proportional to the
FT3 concentration in the sample. Results are determined via a calibration
curve. | |
| 5) Intended use | For the in vitro quantitative determination of free triiodothyronine (FT3) in
human serum and plasma. | |
| 6) Indications
for use | T3 is biologically the most important thyroid hormone and has been shown to
be four to five times more potent than T4. At least 80% of T3 is derived from
the deiodination of T4 by the liver and other peripheral tissues rather than
from direct secretion by the thyroid.
Since T3 and T4 are poorly soluble in plasma, 70% to 75% are transported by
thyroid binding globulin (TBG), a plasma protein. A very low concentration
of free T3 (FT3) and free T4 (FT4) exist in equilibrium in plasma with their
protein-bound counterparts. However, it is the FT3 and FT4 that are the
physiologically active thyroid hormones.. Only these free hormones can bind
to receptors on cell surfaces. The cell then converts FT4 to FT3 which can
deliver its hormonal message by reacting with DNA.
Circulating FT3 is found in very small quantities (the ratio of FT3 to total T3
is 1:300, or about 0.3% of total serum T3). FT3 and FT4 tend to parallel
changes in total T3 and T4, and are not affected by abnormal TBG
concentrations.
FT3 measurements are used in the diagnosis and treatment of thyroid
diseases. It should be noted that increases and decreases of FT3 and FT4 more
accurately reflect hyperthyroidism and hypothyroidism. As such, FT3 is very
useful when other tests reflect borderline or conflicting results. | |
| 6) Comparison
to predicate
device | The Boehringer Mannheim Elecsys FT3 is substantially equivalent to other
products in commercial distribution intended for similar use. Most notably it
is substantially equivalent to the currently marketed Diagnostic Products
Corporation FT3. | |
Continued on next page
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510(k) Summary, Continued
Continued on next page
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510(k) Summary, Continued
Similarities:
- · Intended use: immunoassay for the in vitro quantitative determination of free triiodothyronine (FT3)
- · Competitive test principle
- · Sample type and volume: serum and plasma, 100μl
- · Standardization: weighed in standards
Differences:
| Feature | Enzymun FT3 | DPC FT3 |
|---|---|---|
| Reaction test | ||
| principle | streptavidin microparticles and | |
| electrochemiluminescence | ||
| technology | solid phase radioimmunoassay | |
| technology | ||
| Instrument | ||
| required | ES 300 | gamma counter |
| Measuring | ||
| range | 0.5 to 30 pg/mL | 0.5 to 42 pg/mL |