K Number
K961490
Device Name
ELECSYS T4 ASSAY
Date Cleared
1996-06-13

(56 days)

Product Code
Regulation Number
862.1700
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoassay for the in vitro quantitative determination of total thyroxine in human serum and plasma.
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 uL). • 2nd incubation (9 minutes): After addition of biotinylated T4 (75 uL) and streptavidin-coated microparticles (35 uL), 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.
More Information

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No
The device description details a standard immunoassay based on chemical reactions and light measurement. There is no mention of AI or ML in the device description, performance studies, or key metrics. The results are determined via a calibration curve, which is a traditional method, not indicative of AI/ML.

No.
The device is an in vitro diagnostic immunoassay used to measure total thyroxine, not to treat or directly affect the body's structure or function.

Yes
The intended use states it is an "Immunoassay for the in vitro quantitative determination of total thyroxine in human serum and plasma," which is a measurement used for diagnostic purposes.

No

The device description clearly outlines a complex immunoassay process involving chemical reactions, incubation steps, magnetic capture of microparticles, and chemiluminescent emission measured by a photomultiplier. These are all hardware-dependent processes, indicating the device is not software-only.

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 total 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.
  • Measurement: It performs a "quantitative determination" of a substance (total thyroxine) in these samples.
  • Device Description: The description details a laboratory-based immunoassay process involving reagents, incubation, and measurement of a chemical reaction. This is typical of an IVD.
  • Performance Studies: The performance studies describe analytical characteristics like precision, linearity, and method comparison, which are relevant to the accuracy and reliability of an in vitro test.
  • Predicate Device: The mention of a predicate device (K901346; Enzymun T4 Assay) further confirms its classification as a medical device, and given the context, specifically an IVD.

All of these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.

N/A

Intended Use / Indications for Use

Immunoassay for the in vitro quantitative determination of total thyroxine in human serum and plasma.

Product codes

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 uL).
2nd incubation (9 minutes): After addition of biotinylated T4 (75 uL) and streptavidin-coated microparticles (35 uL), 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

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

Not Found

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: Modified NCCLS (nmol/L):
Sample N=60, Within-Run 33.39 %CV 4.7, Total 33.39 %CV 6.9
Control 1 N=60, Within-Run 113.10 %CV 2.3, Total 113.10 %CV 3.3
Control 2 N=60, Within-Run 180.55 %CV 2.0, Total 180.55 %CV 2.7
Modified NCCLS (µg/dL):
Low N=120, Within-Run 4.55 %CV 2.3, Total 4.55 %CV 3.1
Mid N=120, Within-Run 6.79 %CV 2.4, Total 6.79 %CV 2.9
High N=118, Within-Run 15.49 %CV 2.0, Total 15.49 %CV 2.5
Modified NCCLS (µg/dL):
Sample N=60, Within-Run 2.60 %CV 4.7, Total 2.60 %CV 6.9
Control 1 N=60, Within-Run 8.82 %CV 2.3, Total 8.82 %CV 3.3
Control 2 N=60, Within-Run 14.08 %CV 2.0, Total 14.08 %CV 2.7

Lower Detection Limit: 0.23 µg/dL (3 nmol/L)
Linearity: 0.23 - 24.86 µg/dL (3.0 - 320 nmol/L) (with a deviation from a linear line of ±10%)
Method Comparison: Vs Enzymun-Test® T4
Least Squares: y =1.02x + 0.85, r=0.947, SEE =5.39, N=196
Passing/Bablok: y =0.93x + 4.55, r=0.947, SEE =5.39, N=196

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.)

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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.

K901346

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).

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§ 862.1700 Total thyroxine test system.

(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). 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

JUN 1 3 1896

用 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Image /page/0/Picture/1 description: The image contains the text "K961490 Diagnostics". The text "K961490" is written in a larger, bolder font than the word "Diagnostics". There is also a logo to the left of the word "Diagnostics", but it is too blurry to make out any details.

510(k) Summary

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Boehringer Mannheim Corporation 1. Submitter 2400 Bisso Lane name, P.O. Box 4117 address, Concord, CA 94524-4117 contact (510) 674 - 0690, extension 8415 Contact Person: Mary Koning Date Prepared: April 9, 1996 2. Proprietary name: Elecsys® T4 Assay Device name Common name: Electrochemiluminescence assay for the determination of total thyroxine (T4). Classification name: Radioimmunoassay, Total Thyroxine 3. We claim substantial equivalence to the Enzymun T4 Assay( K901346). Predicate device 4. The Elecsys® test principle is based on competition principle. Total duration Device of assay: 18 minutes (37°C). Description · 1st incubation (9 minutes): Sample (15 µL) and a specific anti-T4 antibody labeled with a ruthenium complex (75 uL). ·2nd incubation (9 minutes): After addition of biotinylated T4 (75 uL) and streptavidin-coated microparticles (35 uL), 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 shows a black square on the left and the word "Diagnostics" on the right. The word is written in a serif font. Below the word "Diagnostics" are two lines of text in a different language.

,

| 4.
Device
Description | •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. | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| 5.
Intended use | Immunoassay for the in vitro quantitative determination of total thyroxine in
human serum and plasma. | |
| 6.
Comparison
to predicate
device | The Boehringer Mannheim Elecsys® T4 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 T4
Assay (K901346). | |
| | The following table compares the Elecsys® T4 Assay with the predicate
device, Enzymun T4 Assay. 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 total thyroxine | |
| | •Sample type: Serum and plasma | |
| | •Antibody: Polyclonal Sheep anti-T4 antibodies | |
| | •Solid phase binding principle: Streptavidin/Biotin | |
| | •Assay standardization: GC/MS Gas Chromatography/Mass
Spectrometry | |
| Feature | Elecsys® T4 | Enzymun T4 |
| 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. | A calibration is required every
run |

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Image /page/2/Picture/0 description: The image shows the word "Diagnostics" in a serif font. The word is in black and is on a white background. To the left of the word is a black square.

في تعدد القرب المقابل المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخ

Comparison to predicate device cont.

Differences:

Performance Characteristics:

FeatureElecsys® T4Enzymun T4
PrecisionModified NCCLS (nmol/L):Modified NCCLS (µg/dL):
LevelSampleControl 1Control 2LowMidHigh
N606060120120118
Within-Run33.39113.10180.554.556.7915.49
%CV4.72.32.02.32.42.0
Total33.39113.10180.554.556.7915.49
%CV6.93.32.73.12.92.5
Modified NCCLS (µg/dL):
SampleControl 1Control 2
N606060
Within-Run2.608.8214.08
%CV4.72.32.0
Total2.608.8214.08
%CV6.93.32.7

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Image /page/3/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 slanted. The black square appears to have some sort of pattern inside of it, but it is difficult to make out the details.

ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤ

Comparison
to predicate device, (cont.)

Performance Characteristics:

FeatureElecsys® T4Enzymun T4
Lower
Detection
Limit0.23 µg/dL
(3 nmol/L)0.6 µg/dL
(7.7 nmol/L)
Linearity0.23 - 24.86 µg/dL (3.0 - 320 nmol/L) (with a deviation from a linear line of ±10%)0.6 - 25.0 µg/dL (with a deviation from a linear line of ±10%)
Method
ComparisonVs Enzymun-Test® T4
Least Squares
$y =1.02x + 0.85$
$r=0.947$
$SEE =5.39$
$N=196$

Passing/Bablok
$y =0.93x + 4.55$
$r=0.947$
$SEE =5.39$
$N=196$ | Vs Enzymun-Test® T4
Least Squares
$y =0.90x - 0.45$
$r=0.996$
$SEE =0.648$
$N=78$ |

Continued on next page

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Performance Characteristics:

: 【: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

ﺮﺏ ﺑﺎﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘ

Comparison

to predicate
device, (cont.)

FeatureElecsys® T4Enzymun T4
Interfering
substancesNo interference at:No interference at:
Bilirubin25 mg/dL64.5 mg/dL
Hemoglobin1 g/dL1 g/dL
Lipemia1500 mg/dL1250 mg/dL
Biotin30 ng/mL200 ng/mL
Specificity% Cross-reactivity% Cross-reactivity
L-T4100100
D-T4100100
L-T31.533.5
D-T31.382.9
3-iodo-L-
tyrosine0.002