(55 days)
Enzymun-Test® TBK (T4 Uptake)
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No
The description details a standard immunoassay based on chemical reactions and optical detection, with results determined via a calibration curve. There is no mention of AI or ML in the device description, performance studies, or key metrics.
No
This device is an immunoassay for in vitro quantitative determination, which provides diagnostic information, not therapy.
Yes
The device quantitatively determines thyroxine-binding capacity in human serum and plasma, which is used for diagnostic purposes related to thyroid function.
No
The device description details a complex immunoassay process involving chemical reactions, magnetic capture of microparticles, and chemiluminescent emission measured by a photomultiplier. This clearly indicates the use of physical hardware components and not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Immunoassay for the in vitro quantitative determination of thyroxine-binding capacity in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
- Sample Type: The device analyzes human serum and plasma, which are biological samples taken from the body but tested outside of it.
- Measurement: It performs a "quantitative determination," meaning it measures the amount of a specific substance (thyroxine-binding capacity) in the sample.
- Test Principle: The description details an immunoassay, which is a common type of test used in IVDs to detect or measure specific substances in biological samples.
- Device Description: The description outlines the steps of the test, including the use of reagents, incubation, and measurement of a signal (chemiluminescent emission) to determine the result. This is characteristic of an IVD.
- Performance Characteristics: The document provides performance data such as precision, linearity, method comparison, and interference studies, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a predicate device (Enzymun-Test® TBK) further confirms that this device is intended for a diagnostic purpose, as predicate devices are used for comparison in regulatory submissions for new IVDs.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of thyroxine-binding capacity in human serum and plasma.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Elecsys® test principle is based on competition principle. Total duration of assay: 18 minutes (37° C).
• 1st incubation (9 minutes): Sample (15 μL), exogenous T4, and biotinylated T4-polyhapten (75 μL).
•2nd incubation (9 minutes): After addition of a specific anti-T4 antibody labeled with a ruthenium complex (75 μL), the polyhapten and the antibody derivative react to form a complex, the concentration of which is inversely proportional to the concentration of the excess, exogenous T4. This immunological complex is bound to the added streptavidin-coated microparticles (35 μL) via the interaction of biotin and streptavidin.
The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
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)
Performance Characteristics:
Precision: Modified NCCLS (TBI)
Level: Sample Control 1, Control 2
N: 60, 60, 60
Within-Run %CV: 2.15, 3.29, 2.39
Total %CV: 3.25, 3.68, 2.66
Lower Detection Limit: 0.2 TBI
Linearity: 0.2 TBI to the value of the highest standard
Method Comparison: Vs Enzymun-Test® TBK
Least Squares: y = 0.99x - 0.03, r = 0.908, SEE = 0.04, N = 319
Passing/Bablok: y = 1.07x - 0.12, r = 0.908, SEE = 0.04, N = 319
Interfering substances:
Bilirubin: No interference at 25 mg/dL
Hemoglobin: No interference at 1 g/dL
Lipemia: No interference at 1500 mg/dL
Biotin: No interference at 30 ng/mL
Specificity:
L-T4: 100% Cross-reactivity
D-T4: 100% Cross-reactivity
L-T3: 1.5% Cross-reactivity
D-T3: 1.4% Cross-reactivity
3-iodo-L-tyrosine: 0.002% Cross-reactivity
3,5-diiodo-L-tyrosine: 0.01% Cross-reactivity
Tetraiodo-thyroacetic acid: 38.5% Cross-reactivity
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.
Enzymun-Test® TBK (T4 Uptake)
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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§ 862.1715 Triiodothyronine uptake test system.
(a)
Identification. A triiodothyronine uptake test system is a device intended to measure the total amount of binding sites available for binding thyroid hormone on the thyroxine-binding proteins, thyroid-binding globulin, thyroxine-binding prealbumin, and albumin of serum and plasma. The device provides an indirect measurement of thyrkoxine levels in serum and plasma. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders.(b)
Classification. Class II. The 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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مینیا
مینیا کے شہر
حوالہ جات
Image /page/0/Picture/1 description: The image shows the word "Diagnostics" in a serif font. Below the word "Diagnostics" are two Korean words. The Korean words are "에 대해 이 지원에".
JUN | 2 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 |
| 2400 Bisso Lane | |
| P.O. Box 4117 | |
| Concord, CA 94520-4117 | |
| (510) 674 - 0690, extension 8415 |
Contact Person: Mary Koning
Date Prepared: April 9, 1996 |
| 2.
Device name | Proprietary name: Elecsys® T-Uptake Assay
Common name: Electrochemiluminescence assay for the thyroxine-binding capacity (T-Uptake).
Classification name: Thyroxine-binding globulin test system |
| 3.
Predicate device | We claim substantial equivalence to the Enzymun-Test® TBK (T4 Uptake) |
| 4.
Device Description | The Elecsys® test principle is based on competition principle. Total duration of assay: 18 minutes (37° C).
• 1st incubation (9 minutes): Sample (15 $\mu$ L), exogenous T4, and biotinylated T4-polyhapten (75 $\mu$ L).
•2nd incubation (9 minutes): After addition of a specific anti-T4 antibody labeled with a ruthenium complex (75 $\mu$ L), the polyhapten and the antibody derivative react to form a complex, the concentration of which is inversely proportional to the concentration of the excess, exogenous T4. This immunological complex is bound to the added streptavidin-coated microparticles (35 $\mu$ L) via the interaction of biotin and streptavidin. |
1
Image /page/1/Picture/0 description: The image shows a logo and the word "Diagnostics". The logo is a black square with some white lines and shapes inside. The word "Diagnostics" is written in a serif font and is located to the right of the logo.
·The reaction mixture is aspirated into the measuring cell where the 4. Device microparticles are magnetically captured onto the surface of the electrode. Description, Unbound substances are then removed with ProCell. Application of a voltage cont. to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). ·Results are determined via a calibration curve which is instrumentspecifically generated by 2-point calibration and a master curve provided via the reagent bar code. ડ. Immunoassay for the in vitro quantitative determination of thyroxine-binding Intended use capacity in human serum and plasma.
2
6. Comparison to predicate device
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
The Boehringer Mannheim Elecsys® T-Uptake Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun-Test® TBK (T4 Uptake).
The following table compares the Elecsys® T-Uptake with the predicate device, Enzymun-Test® TBK (T4 Uptake). Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device in provided in attachment 6.
Similarities:
- · Detection of Thyroxine-Binding Capacity (T-Uptake)
- · Sample type: Serum and plasma
- · Reportable range of 0.2 1.9 TBI
- · Standardized according to Enzymun-Test® TBK Assay
- · Polyclonal Antibody: Sheep polyclonal anti-T-Uptake
- · Solid phase binding principle: Streptavidin/Biotin Differences:
| Feature | Elecsys® T Uptake | Enzymun-Test® TBK |
|---|---|---|
| Reaction test | ||
| principle | Electrochemiluminescence | ELISA/1-step sandwich assay |
| using streptavidin technology | ||
| Instrument | ||
| required | Elecsys® 2010 | ES 300 |
| Calibration | ||
| Stability | A calibration is recommended | |
| every 7 days if kit is not | ||
| consumed; 4 weeks with same | ||
| reagent lot if reagent is | ||
| consumed within 7 days. | Calibration required every run |
3
Performance Characteristics:
.
Comparison
to predicate
device, (cont.)
| Feature | Elecsys® T Uptake | Enzymun-Test® TBK |
|---|---|---|
| Precision | Modified NCCLS (TBI): | Modified NCCLS (TBI): |
| Level | Sample Control 1 Control 2 | Low Mid High |
| N | 60 60 60 | 118 120 119 |
| Within-Run | 0.95 0.94 1.09 | 0.61 0.93 1.28 |
| %CV | 2.15 3.29 2.39 | 5.7 2.6 1.4 |
| Total | 0.95 0.94 1.09 | 0.61 0.93 1.28 |
| %CV | 3.25 3.68 2.66 | 7.2 3.4 2.0 |
| Lower | ||
| Detection | ||
| Limit | 0.2 TBI | 0.2 TBI |
| Linearity | 0.2 TBI to the value of the | |
| highest standard | 0.2 TBI to the value of the | |
| highest standard | ||
| Method | ||
| Comparison | Vs Enzymun-Test® TBK | |
| Least Squares | ||
| $y =0.99x - 0.03$ | ||
| $r=0.908$ | ||
| $SEE =0.04$ | ||
| $N=319$ | ||
| Passing/Bablok | ||
| $y = 1.07x - 0.12$ | ||
| $r=0.908$ | ||
| $SEE =0.04$ | ||
| $N=319$ | Vs Enzymun-Test® TBK | |
| Least Squares | ||
| $y = 1.02x + 0.084$ | ||
| $r= 0.986$ | ||
| $SEE = 0.054$ | ||
| $N= 52$ |
4
Image /page/4/Picture/0 description: The image shows the word "Diagnostics" in a serif font. The text is positioned to the right of a dark, blurry square. The word is written in black ink on a white background. The image appears to be a title or heading for a document or presentation.
لب
المشاركة
المستوى المشاركة
المستوى المنتشار
ست
Comparison
to predicate device, (cont.) Performance Characteristics, cont.:
| Feature | Elecsys® T Uptake | Enzymun-Test® TBK |
|---|---|---|
| Interfering | ||
| substances | No interference at: | No interference at: |
| Bilirubin | 25 mg/dL | 64.5 mg/dL |
| Hemoglobin | 1 g/dL | 1 g/dL |
| Lipemia | 1500 mg/dL | 1250 mg/dL |
| Biotin | 30 ng/mL | 200 ng/mL |
| Specificity | % Cross-reactivity | % Cross-reactivity |
| L-T4 | 100 | 100 |
| D-T4 | 100 | 100 |
| L-T3 | 1.5 | 3.5 |
| D-T3 | 1.4 | 2.9 |
| 3-iodo-L- | ||
| tyrosine | 0.002 |