(54 days)
Not Found
No
The description details a standard immunoassay based on chemical reactions and light detection, with results determined by a calibration curve. There is no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an immunoassay for in vitro quantitative determination, meaning it is a diagnostic tool used to measure substances in human samples, not to treat a medical condition.
Yes
The device is described as an "Immunoassay for the in vitro quantitative determination of free thyroxine in human serum and plasma," which directly indicates its use in measuring a specific substance in the body's fluids to aid in diagnosis.
No
The device description clearly outlines a complex immunoassay process involving chemical reactions, microparticles, magnetic capture, and chemiluminescent emission measured by a photomultiplier. This indicates a hardware-based system, not a software-only device.
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 free thyroxine 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.
- Test Principle: The description details a laboratory-based immunoassay process involving chemical reactions and measurement of a substance in a sample.
- Performance Studies: The document describes performance studies conducted on the device using biological samples, which is typical for IVDs to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a predicate device (K900883; Enzymun-Test® FT4) which is also an immunoassay for FT4, further confirms its classification as an IVD.
All these elements 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 free thyroxine in human serum and plasma.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
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) and a specific anti-T4 antibody labeled with a ruthenium complex (75 µL). • 2nd incubation (9 minutes): After addition of biotinylated T4 (75 µL) and streptavidin-coated microparticles (35 µL), 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. 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
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:
Modified NCCLS (pmol/L):
Level: Sample Control 1, Control 2
N: 60, 17.53, 50.84
Within-Run %CV: 1.58, 1.43, 2.85
Total %CV: 8.77, 17.53, 50.84, 3.54, 2.72, 6.59
Modified NCCLS (ng/dL):
Sample: Control 1, Control 2
N: 60, 1.367, 3.97
Within-Run %CV: 1.58, 1.43, 2.85
Total %CV: 0.684, 1.367, 3.97, 3.54, 2.72, 2.85
Sensitivity:
Lower Detection Limit: 0.023 ng/dL (0.3 pmol/L)
Method Comparison (Vs Enzymun-Test® FT4):
Least Squares: y = 0.954x + 0.18, r = 0.981, SEE = 1.11, N = 315
Passing/Bablok: y = 1.02x + 0.36, r = 0.981, SEE = 1.11, N = 315
Interfering substances:
No interference at: Bilirubin 25 mg/dL, Hemoglobin 1 g/dL, Lipemia 1500 mg/dL, Biotin 30 ng/mL
Specificity (% Cross-reactivity):
L-T4: 100
D-T4: 100
L-T3: 1.53
D-T3: 1.38
3-iodo-L-tyrosine: 0.002
3,5-diiodo-L-tyrosine: 0.01
Tetraiodo-thyroacetic acid: 38.5
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: Lower Detection Limit: 0.023 ng/dL (0.3 pmol/L)
Specificity: L-T4: 100%, D-T4: 100%, L-T3: 1.53%, D-T3: 1.38%, 3-iodo-L-tyrosine: 0.002%, 3,5-diiodo-L-tyrosine: 0.01%, Tetraiodo-thyroacetic acid: 38.5%
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® FT4 (K900883)
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.
Not Found
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).
Not Found
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.
0
K9Cd489
Image /page/0/Picture/1 description: The image contains the word "Diagnostics" in a stylized font. Above the word "Diagnostics" is a black square with some white markings. Below the word "Diagnostics" are the words "a manufacturer".
היישוק
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 | ||
| Concord, CA 94524-4117 | ||
| (510) 674-0667; extension 8240 |
Contact Person: Betsy Soares-Maddox
Date Prepared: April 9, 1996 | |
| 2.
Device name | Proprietary name: Elecsys® FT4 Assay
Common name: Electrochemiluminescence assay for the determination of free thyroxine (FT4).
Classification name: Radioimmunoassay, Free Thyroxine | |
| 3.
Predicate
device | We claim substantial equivalence to the Enzymun-Test® FT4 (K900883) | |
| 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 µL) and a specific anti-T4 antibody labeled with a ruthenium complex (75 µL).
• 2nd incubation (9 minutes): After addition of biotinylated T4 (75 µL) and streptavidin-coated microparticles (35 µL), 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. | |
Continued on next page
.
1
Image /page/1/Picture/0 description: The image contains a black square on the left side and the word "Diagnostics" on the right side. The word is written in a serif font and is slightly italicized. The black square appears to have some vertical lines or patterns within it.
·The reaction mixture is aspirated into the measuring cell where the 4. microparticles are magnetically captured onto the surface of the electrode. Device 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. Immunoassay for the in vitro quantitative determination of free thyroxine in ર. Intended use human serum and plasma. ર . The Boehringer Mannheim Elecsys® FT4 is substantially equivalent to other Comparison products in commercial distribution intended for similar use. Most notably it to predicate is substantially equivalent to the currently marketed Enzymun-Test® FT4 device (K900883). The following table compares the Elecsys® FT4 with the predicate device, Enzymun-Test® FT4. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6. Similarities: · Intended Use: Immunoassay for the in vitro quantitative determination of free thyroxine ·Sample type: Serum and plasma · Antibody: Polyclonal Sheep anti-FT4 antibodies · Solid phase binding principle: Streptavidin/Biotin · Assay standardization: Equilibrium dialysis Continued on next page
2
Image /page/2/Picture/0 description: The image contains the word "Diagnostics" in a stylized font. The word is positioned to the right of a dark, rectangular shape. The text "anaları" is present above the word "Diagnostics", but it is less prominent.
6
in
Differences:
Comparison to predicate
device cont.
| Feature | Elecsys® FT4 | Enzymun-Test® FT4 |
|---|---|---|
| Reaction test | ||
| principle | Electrochemiluminescence | ELISA/1-step sandwich assay |
| using streptavidin technology | ||
| Instrument | ||
| required | Elecsys® 2010 | ES 300 |
| Assay Range | Reportable Range: | |
| 0.023 ng/dL - 7.77 ng/dL | ||
| (0.3 - 100.0 pmol/L) | Reportable Range: | |
| 0.1 ng/dL - 6.5 ng/dL | ||
| (1.29 - 83.69 pmol/L) | ||
| 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. | A calibration is required every | |
| 2 weeks. |
Continued on next page
3
Image /page/3/Picture/0 description: The image shows the word "Diagnostics" in a serif font. To the left of the word is a black square. Below the word "Diagnostics" are the numbers "2019" and "191".
6.
Comparison to predicate device, (cont.)
Performance Characteristics:
| Feature | Elecsys® FT4 | Enzymun-Test® FT4 |
|---|---|---|
| Precision | Modified NCCLS (pmol/L): | Modified NCCLS (ng/dL): |
| Level | Sample Control 1 Control 2 | Low Mid High |
| N | ||
| Within-Run | ||
| %CV | ||
| Total | ||
| %CV | 60 17.53 50.84 | |
| 1.58 1.43 2.85 | ||
| 8.77 17.53 50.84 | ||
| 3.54 2.72 6.59 | 117 120 120 | |
| 0.49 1.17 4.43 | ||
| 3.9 2.4 1.2 | ||
| 0.49 1.17 4.43 | ||
| 5.1 2.9 2.0 | ||
| Modified NCCLS (ng/dL): | ||
| Sample Control 1 Control 2 | ||
| N | ||
| Within-Run | ||
| %CV | ||
| Total | ||
| %CV | 60 1.367 3.97 | |
| 1.58 1.43 2.85 | ||
| 0.684 1.367 3.97 | ||
| 3.54 2.72 2.85 | ||
| Sensitivity | Lower Detection Limit: | |
| 0.023 ng/dL | ||
| (0.3 pmol/L) | Lower Detection Limit: | |
| 0.1 ng/dL | ||
| (1.29 pmol/L) | ||
| Method | ||
| Comparison | Vs Enzymun-Test® FT4 | |
| Least Squares | ||
| $y =0.954x + 0.18$ | ||
| $r=0.981$ | ||
| $SEE =1.11$ | ||
| $N=315$ |
Passing/Bablok
$y =1.02x + 0.36$
$r=0.981$
$SEE =1.11$
$N=315$ | Vs Enzymun-Test® FT4
Least Squares
$y = 0.88x + 0.15$
$r=0.984$
$SEE = 0.199$
$N= 77$ |
Continued on next page
:
4
Image /page/4/Picture/0 description: The image shows the word "Diagnostics" in a serif font. To the left of the word is a black square with some white markings on it. Below the word "Diagnostics" are the numbers "1 . 11".
6. Comparison
to predicate
device, (cont.)
Performance Characteristics, cont.:
| Feature | Elecsys® FT4 | Enzymun-Test® FT4 |
|---|---|---|
| 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 | 1.53 | 3.5 |
| D-T3 | 1.38 | 2.9 |
| 3-iodo-L- | ||
| tyrosine | 0.002 |