(126 days)
Enzymun-Test® FT3
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No
The device description details a standard immunoassay using electrochemiluminescence detection, and there is no mention of AI or ML in the device description, performance studies, or key metrics.
No
This device is for in vitro quantitative determination of free triiodothyronine (FT3) in human serum and plasma, which is a diagnostic function, not a therapeutic one.
Yes
The device performs an "in vitro quantitative determination of free triiodothyronine (FT3) in human serum and plasma" to measure a substance that "regulate[s] metabolism," which is a diagnostic measurement.
No
The device description clearly outlines a physical in vitro diagnostic test kit involving reagents, microparticles, and electrochemiluminescence detection, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro quantitative determination of free triiodothyronine (FT3) in human serum and plasma." This means the device is used to test samples taken from the human body (in vitro) to measure a specific substance (FT3).
- Device Description: The description details a laboratory-based test principle involving chemical reactions and detection methods applied to the sample. This is characteristic of an in vitro diagnostic device.
- Performance Studies: The document describes performance studies like precision, sensitivity, assay range, and method comparison, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" (Enzymun-Test® FT3) is common in regulatory submissions for IVD devices, where a new device is compared to an already approved one.
All these elements strongly indicate that the Elecsys FT3 is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Elecsys FT3 is for the in vitro quantitative determination of free triiodothyronine (FT3) in human serum and plasma. Triiodothyronine is one of the thyroid hormones present in serum which regulate metabolism.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Elecsys FT3 employs a competitive test principle with polyclonal antibodies directed against T3 and with streptavidin microparticles and electrochemiluminescence detection.
1st Incubation: Sample (30 µl) and a specific anti-T3 antibody labeled with a ruthenium complex.
2nd Incubation: After addition of biotinylated T3 and streptavidin-coated microparticles, the still-free binding sites of the labeled antibody become occupied, with formation of an antibody-hapten complex. The entire complex is bound to the solid phase via 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.
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)
Precision:
Study Type: NCCLS (Modified) (EP5-T2) for Elecsys FT3, NCCLS "Midi" (EP5-T) for Enzymun-Test FT3.
Sample Size: 60 for Elecsys FT3 (PC U1, PC U2, HS1, HS2, HS3), 120 for Enzymun-Test FT3 (1, 2, 3).
Key Results:
Elecsys FT3:
PC U1: Mean 7.64, wi/in run %CV 2.0, total run %CV 3.6
PC U2: Mean 20.8, wi/in run %CV 2.5, total run %CV 3.3
HS1: Mean 5.11, wi/in run %CV 2.3, total run %CV 4.7
HS2: Mean 10.5, wi/in run %CV 2.1, total run %CV 3.1
HS3: Mean 14.4, wi/in run %CV 2.3, total run %CV 2.7
Enzymun-Test FT3:
1: Mean 2.71, wi/in run %CV 3.8, total run %CV 4.5
2: Mean 7.86, wi/in run %CV 2.3, total run %CV 2.4
3: Mean 28.97, wi/in run %CV 2.7, total run %CV 3.1
Sensitivity:
Lower Detection Limit: Elecsys FT3: 0.40 pmol/l (0.26 pg/ml); Enzymun-Test FT3: 0.47 pmol/l (0.5 pg/ml).
Assay range (LDL to highest standard): Elecsys FT3: 0.40 - 50 pmol/l (0.26 - 32 pg/ml); Enzymun-Test FT3: 0.47 - 46 pmol/l (0.5 - 30 pg/ml).
Method Comparison:
vs. Enzymun-Test FT3:
Least Squares: N = 298, y = - 0.22 + 0.90x, r = 0.94
Passing/Bablok: N = 298, y = - 1.45 + 1.06x, r = 0.94
vs. Elkins Equilibrium Dialysis:
Least Squares: N = 22, y = 0.99x +0.203, r = 0.998
Interfering substance:
No interference up to: Hemoglobin 1 g/dl, Lipemia 1500 mg/dl, Bilirubin 25 mg/dl, Biotin 30 ng/ml for Elecsys FT3.
No interference up to: Hemoglobin 1 g/dl, Lipemia 1250 mg/dl, Bilirubin 17 mg/dl, Biotin 30 ng/ml for Enzymun-Test FT3.
Specificity (% cross reaction):
Elecsys FT3: D-T3 98.86, L-T4 0.115, D-T4 0.115, L-rT3 0.007, 3,3',5-tri-iodothyroacetic acid 106.4, 3,3',5,5'-tetra-iodothyroacetic acid 0.007.
Enzymun-Test FT3: D-T3 140, L-T4 0.16, D-T4 0.07, L-rT3 0.04, 3,3',5-tri-iodothyroacetic acid 7.5, 3,3',5,5'-tetra-iodothyroacetic acid 0.01.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity:
Lower Detection Limit: 0.40 pmol/l (0.26 pg/ml) for Elecsys FT3.
Lower Detection Limit: 0.47 pmol/l (0.5 pg/ml) for Enzymun-Test FT3.
Specificity (% cross reaction):
D-T3: 98.86 (Elecsys FT3), 140 (Enzymun-Test FT3)
L-T4: 0.115 (Elecsys FT3), 0.16 (Enzymun-Test FT3)
D-T4: 0.115 (Elecsys FT3), 0.07 (Enzymun-Test FT3)
L-rT3: 0.007 (Elecsys FT3), 0.04 (Enzymun-Test FT3)
3,3',5-tri-iodothyroacetic acid: 106.4 (Elecsys FT3), 7.5 (Enzymun-Test FT3)
3,3',5,5'-tetra-iodothyroacetic acid: 0.007 (Elecsys FT3), 0.01 (Enzymun-Test FT3)
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® 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.
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510(k) Summary
DEC 1 6 1996
| 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: LeeAnn Chambers | |
| Date Prepared: August 9, 1996 | |
| 2) Device name | Proprietary name: Elecsys® FT3 |
| Common name: free triiodothyronine test system | |
| 3) Predicate device | We claim substantial equivalence to the Enzymun-Test® FT3. |
| 4) Device Description | The Elecsys FT3 employs a competitive test principle with polyclonal antibodies directed against T3 and with streptavidin microparticles and electrochemiluminescence detection. |
| 1st Incubation: Sample (30 µl) and a specific anti-T3 antibody labeled with a ruthenium complex.2nd Incubation: After addition of biotinylated T3 and streptavidin-coated microparticles, the still-free binding sites of the labeled antibody become occupied, with formation of an antibody-hapten complex. The entire complex is bound to the solid phase via interaction of biotin and streptavidin. |
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Image /page/1/Picture/1 description: This image describes the device, intended use, and indications for use of a medical device. The device description explains that the reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. The intended use is for the in vitro quantitative determination of free triiodothyronine (FT3) in human serum and plasma. The indications for use explain that triiodothyronine is one of the thyroid hormones present in serum which regulate metabolism.
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Image /page/2/Picture/1 description: The image provides information on the indications for use and comparison to predicate devices. It mentions that a variety of methods are available for estimating free thyroid hormone levels, with direct measurement of fT4 and fT3 via equilibrium dialysis or ultrafiltration being a reference method. The image also lists references and similarities between the Boehringer Mannheim Elecsys FT3 and the Enzymun-Test® FT3, including intended use, test principle, sample type, antibody, and capture principle.
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F. Substantial Differences: equivalence,
cont.
| Feature | Elecsys FT3 | Enzymun-Test FT3 |
|---|---|---|
| Reaction test | ||
| principle | streptavidin microparticles and | |
| electrochemiluminescence | streptavidin-coated tubes and | |
| enzyme immunoassay | ||
| technology | technology | |
| Sample | ||
| volume | 30 µ1 | 100 µl |
| Instrument | ||
| required | Elecsys 2010 | ES 300 |
| Calibration | a two point calibration renewal | |
| is recommended every 7 days | ||
| or 1 month if the same reagent | ||
| lot is used and the reagent pack | ||
| is consumed within 7 days | a full calibration curve run is | |
| recommended every 2 weeks |
Performance Characteristics:
| Feature | Elecsys FT3 | Enzymun-Test FT3 | ||||||
|---|---|---|---|---|---|---|---|---|
| Precision | NCCLS (Modified) (EP5-T2) | NCCLS "Midi" (EP5-T) | ||||||
| Sample | PC U1* | PC U2* | HS1 | HS2 | HS3 | 1 | 2 | 3 |
| N | 60 | 60 | 60 | 60 | 60 | 120 | 120 | 120 |
| Mean | 7.64 | 20.8 | 5.11 | 10.5 | 14.4 | 2.71 | 7.86 | 28.97 |
| wi/in run %CV | 2.0 | 2.5 | 2.3 | 2.1 | 2.3 | 3.8 | 2.3 | 2.7 |
| total run %CV | 3.6 | 3.3 | 4.7 | 3.1 | 2.7 | 4.5 | 2.4 | 3.1 |
| Sensitivity | Lower Detection Limit: | Lower Detection Limit: | ||||||
| 0.40 pmol/l | 0.47 pmol/l | |||||||
| 0.26 pg/ml | 0.5 pg/ml | |||||||
| Assay range | ||||||||
| (LDL to highest | ||||||||
| standard) | 0.40 - 50 pmol/l | 0.47 - 46 pmol/l | ||||||
| 0.26 - 32 pg/ml | 0.5 - 30 pg/ml |
- PC U1 and PC U2 = PreciControl Universal 1 and 2
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F. Substantial
Performance Characteristics, continued:
equivalence,
cont.
| Method Comparison | vs. Enzymun-Test FT3 | vs. Elkins Equilibrium Dialysis |
|---|---|---|
| Least Squares | Least Squares | |
| N = 298 | N = 22 | |
| y = - 0.22 + 0.90x | y = 0.99x +0.203 | |
| r = 0.94 | r = 0.998 | |
| Passing/Bablok | ||
| N = 298 | ||
| y = - 1.45 + 1.06x | ||
| r = 0.94 | ||
| Interfering substance: | No interference up to: | No interference up to: |
| Hemoglobin | 1 g/dl | 1 g/dl |
| Lipemia | 1500 mg/dl | 1250 mg/dl |
| Bilirubin | 25 mg/dl | 17 mg/dl |
| Biotin | 30 ng/ml | 30 ng/ml |
| Specificity | % cross reaction | % cross reaction |
| D-T3 | 98.86 | 140 |
| L-T4 | 0.115 | 0.16 |
| D-T4 | 0.115 | 0.07 |
| L-rT3 | 0.007 | 0.04 |
| 3,3',5-tri-iodothyroacetic acid | 106.4 | 7.5 |
| 3,3',5,5'-tetra-iodothyroacetic | ||
| acid | 0.007 | 0.01 |