(49 days)
Not Found
Not Found
No
The device description details a competitive immunoassay using electrochemiluminescence detection and a calibration curve. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic (IVD) device used for the quantitative determination of total triiodothyronine (T3) in human serum and plasma, which aids in diagnosis. It does not provide therapy or treatment.
Yes.
The device is intended for the "in vitro quantitative determination of total triiodothyronine (T3) in human serum and plasma," and the determination of T3 is utilized in the "diagnosis of T3-hyperthyroidism, the detection of early stages of hyperthyroidism and for indicating a diagnosis of thyrotoxicosis factitia."
No
The device description clearly outlines a physical assay using reagents, microparticles, and electrochemiluminescence detection, which are hardware components and chemical processes, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For the in vitro quantitative determination of total triiodothyronine (T3) in human serum and plasma." The phrase "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.
- Measurement: It performs a "quantitative determination" of a specific analyte (total triiodothyronine (T3)).
- Purpose: The determination of T3 is used in the "diagnosis of T3-hyperthyroidism, the detection of early stages of hyperthyroidism and for indicating a diagnosis of thyrotoxicosis factitia," which are medical conditions.
- Device Description: The description details a laboratory-based assay using reagents, microparticles, and electrochemiluminescence detection, all typical components of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
For the in vitro quantitative determination of total triiodothyronine (T3) in human serum and plasma.
Triiodothyronine (T3) is the hormone principally responsible for the development of the effects of the thyroid hormones on the various target organs.
T3 (3.5,3' Triiodothyronine) is mainly formed extra-thyroidally, particularly in the liver, by enzymatic 5'-deiodination of T4. Accordingly, the T3 concentration in serum is more a reflection of the functional state of the peripheral tissue than the secretory performance of the thyroid gland.
A reduction in the conversion of T4 to T3 results in a fall in the T3 concentration. It occurs under the influence of medications such as propanolol, glucocorticoids or amiodarone and in severe non-thyroidal general diseases - "non-thyroidal illness" (NTI) - and is referred to as the "low T3 syndrome." Like T4, over 99% of T3 is bound to transport proteins, but its affinity to them is around 10-fold lower.1-3,7
The determination of T3 is utilized in the diagnosis of T3-hyperthyroidism, the detection of early stages of hyperthyroidism and for indicating a diagnosis of thyrotoxicosis factitia.4-6
Product codes (comma separated list FDA assigned to the subject device)
CDP, JIS
Device Description
The Elecsys® T3 employs a competitive test principle with polyclonal antibodies directed against T3 and with streptavidin microparticles and electrochemiluminescence detection.
Total duration of assay: 18 minutes.
• 1st Incubation: Sample (30 µl) and specific anti-T3 antibodies labeled with a ruthenium complex together with ANS to release T3 from serum.
• 2nd Incubation: After the addition of streptavidin-coated microparticles and biotinylated T3, 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.
• 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:
Elecsys T3: NCCLS (modified) (EP5-T2)
Sample: PC U1, N=60, Mean=2.12 nmol/l, wi/in run % CV=4.1, total run % CV=4.8
Sample: PC U2, N=60, Mean=6.31 nmol/l, wi/in run % CV=3.5, total run % CV=4.1
Sample: HS1, N=60, Mean=1.22 nmol/l, wi/in run % CV=3.6, total run % CV=5.4
Sample: HS2, N=60, Mean=2.87 nmol/l, wi/in run % CV=4.2, total run % CV=4.7
Sample: HS3, N=60, Mean=5.09 nmol/l, wi/in run % CV=5.3, total run % CV=5.4
Enzymun-Test® T3: Modified NCCLS “Midi” (EP3-T)
Sample: 1, N=118, Mean=0.95 nmol/l, wi/in run % CV=2.9, total run % CV=4.7
Sample: 2, N=120, Mean=2.56 nmol/l, wi/in run % CV=1.6, total run % CV=2.2
Sample: 3, N=117, Mean=4.26 nmol/l, wi/in run % CV=1.7, total run % CV=2.8
Sensitivity:
Elecsys T3: Lower Detection Limit: 0.3 nmol/l (0.19 ng/ml)
Enzymun-Test® T3: Lower Detection Limit: 0.46 nmol/l (0.3 ng/ml)
Assay Range:
Elecsys T3: 0.3 - 10.00 nmol/l (0.19 - 6.51 ng/ml)
Enzymun-Test® T3: 0.46 - 9.22 nmol/l (0.3 - 6.0 ng/ml)
Method Comparison:
vs. Enzymun-Test T3 (Cat. # 1360868)
Least Squares: N = 300, y = -0.35 + 1.18x, r = 0.957
Passing/Bablok: N = 300, y = -0.56 + 1.26x, r = 0.957
vs. Enzymun-Test T3 (Cat. # 1135287)
Least Squares: N = 55, y = 1.13x + 0.02, r = 0.994
Interfering substance:
Elecsys T3: No interference up to: Hemoglobin 1 g/dl, Lipemia 1500 mg/dl, Bilirubin 25 mg/dl, Biotin 20 ng/ml
Enzymun-Test T3: No interference up to: Hemoglobin 1 g/dl, Lipemia 1250 mg/dl, Bilirubin 65 mg/dl, Biotin 50 ng/ml
Specificity:
Elecsys T3 % cross reaction:
D-T3: 98.9
L-T4: 0.115
D-T4: 0.115
L-rT3: 0.007
L-T2: 0.998
3,3',5-tri- iodothyroacetic acid: 106.4
3,3',5,5'-tetra- iodothyroacetic acid: 0.007
Enzymun-Test® T3 % cross reaction:
D-T3: 100
L-T4: 0.16
D-T4: 0.07
L-rT3: 0.04
L-T2: 1.0
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:
Elecsys T3: Lower Detection Limit: 0.3 nmol/l (0.19 ng/ml)
Enzymun-Test® T3: Lower Detection Limit: 0.46 nmol/l (0.3 ng/ml)
Specificity:
Elecsys T3 % cross reaction: D-T3: 98.9, L-T4: 0.115, D-T4: 0.115, L-rT3: 0.007, L-T2: 0.998, 3,3',5-tri- iodothyroacetic acid: 106.4, 3,3',5,5'-tetra- iodothyroacetic acid: 0.007
Enzymun-Test® T3 % cross reaction: D-T3: 100, L-T4: 0.16, D-T4: 0.07, L-rT3: 0.04, L-T2: 1.0, 3,3',5-tri- iodothyroacetic acid: 7.5, 3,3',5,5'-tetra- iodothyroacetic acid: 0.01
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® T3
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
§ 862.1710 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
AUG 1 5 1996
510(k) Summary
Image /page/0/Picture/2 description: The image shows a logo for Boehringer Mannheim. The logo consists of a black square with the word "mannheim" written vertically along the left side. Inside the square is a white circle with the word "boehringer" written horizontally across the center of the circle.
人962508
| 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: June 24, 1996 | |
| 2) Device name | Proprietary name: Elecsys T3 |
| Common name: Total triiodothyronine test system | |
| 3) Predicate | |
| device | We claim substantial equivalence to the Enzymun-Test® T3. |
| 4) Device | |
| Description | The Elecsys® T3 employs a competitive test principle with polyclonal |
| antibodies directed against T3 and with streptavidin microparticles and electrochemiluminescence detection. | |
| Total duration of assay: 18 minutes. | |
| • 1st Incubation: Sample (30 µl) and specific anti-T3 antibodies labeled with a ruthenium complex together with ANS to release T3 from serum. | |
| • 2nd Incubation: After the addition of streptavidin-coated microparticles and biotinylated T3, 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/Figure/0 description: The image shows the number 4760000 at the top. Below that is a logo for Boehringer Mannheim. The logo is a black square with a white circle in the middle. The words "boehringer" are written in the center of the circle, and the words "mannheim" are written vertically on the left side of the square.
AUG | 5 1996
510(k) Summary, Continued
| 4) Device
Description
(cont.) | • 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.
• 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 | For the in vitro quantitative determination of total triiodothyronine (T3) in
human serum and plasma. |
| 5) Indications
for use | Triiodothyronine (T3) is the hormone principally responsible for the
development of the effects of the thyroid hormones on the various target
organs. |
| | T3 (3.5,3' Triiodothyronine) is mainly formed extra-thyroidally, particularly
in the liver, by enzymatic 5'-deiodination of T4. Accordingly, the T3
concentration in serum is more a reflection of the functional state of the
peripheral tissue than the secretory performance of the thyroid gland. |
| | A reduction in the conversion of T4 to T3 results in a fall in the T3
concentration. It occurs under the influence of medications such as
propanolol, glucocorticoids or amiodarone and in severe non-thyroidal
general diseases - "non-thyroidal illness" (NTI) - and is referred to as the
"low T3 syndrome." Like T4, over 99% of T3 is bound to transport proteins,
but its affinity to them is around 10-fold lower.1-3,7 |
| | Continued on next page |
2
Image /page/2/Picture/0 description: The image shows a logo for Boehringer Mannheim. The logo is a black square with the word "mannheim" written vertically on the left side. Inside the square is a circle with the word "boehringer" written inside it.
510(k) Summary, Continued
| 5) Indications
for use | The determination of T3 is utilized in the diagnosis of T3-hyperthyroidism,
the detection of early stages of hyperthyroidism and for indicating a diagnosis
of thyrotoxicosis factitia.4-6 | | | | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| | References
1 Wheeler MH, Lazarus JH. Diseases of the Thyroid. Chapman and Hall
Medical. London Glasgow Weinheim New York Tokyo Melbourne Madras
1994;107-115.
2 Pfannenstiel P, Saller B. Schilddrüsenkrankheiten Diagnose und Therapie.
Berliner Medizinische Verlagsanstalt GmbH 1995; 2:30-32,60-62.
3 Fisher DA. Physiological variations in thyroid hormones physiological and
pathophysiological considerations. Clinical Chemistry 1996;42:135-139.
4 Klee GG. Clinical usage recommendations and analytic performance goals for
total and free triiodothyronine measurements. Clinical Chemistry 1996;42:155-
159.
5 Surks MI, Chopra IJ, Mariash CN, Nicoloff JT, Solomon DH. American
Thyroid Association guidelines for use of laboratory tests in thyroid disorders.
JAMA 1990;63:1529-1532.
6 Becker DV, Bigos ST, Gaitan E, Morris JC, Rallison ML, Spencer CA, et at.
Optimal use of blood tests for assessment of thyroid function (letter). JAMA
1993. 269:273.
7. Wild D. The Immunoassay Handbook. Stockton Press 1994; 338. | | | | |
| 6) Comparison
to predicate
device | The Boehringer Mannheim Elecsys T3 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® T3.
Similarities: Intended use: immunoassay for the in vitro quantitative determination of
Total Triiodothyronine (T3) Competitive test principle Sample type: serum and plasma Antibody: sheep anti-T3 polyclonal Capture principle: streptavidin / biotin | | | | |
Continued on next page
3
Image /page/3/Picture/0 description: The image shows a logo with the text "mannheim" vertically aligned on the left side and the text "boehringer" inside a circle on the right side. The background is black, and the text and circle are white. The logo appears to be for a company or organization with the name Boehringer Mannheim.
510(k) Summary, Continued
- Comparison to predicate device (cont.)
Differences:
| Feature | Elecsys T3 | Enzymun-Test T3 |
|---|---|---|
| Reaction test | ||
| principle | streptavidin microparticles and | |
| electrochemiluminescence | ||
| technology | streptavidin-coated tubes and | |
| enzyme immunoassay | ||
| technology | ||
| Sample | ||
| volume | 30 µl | 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 T3 | Enzymun-Test® T3 | ||||||
|---|---|---|---|---|---|---|---|---|
| Precision: | NCCLS (modified) (EP5-T2): | Modified NCCLS “Midi” (EP3-T) | ||||||
| Sample | PC U1 | PC U2 | HS1 | HS2 | HS3 | 1 | 2 | 3 |
| N | 60 | 60 | 60 | 60 | 60 | 118 | 120 | 117 |
| Mean (nmol/l) | 2.12 | 6.31 | 1.22 | 2.87 | 5.09 | 0.95 | 2.56 | 4.26 |
| wi/in run % CV | 4.1 | 3.5 | 3.6 | 4.2 | 5.3 | 2.9 | 1.6 | 1.7 |
| total run % CV | 4.8 | 4.1 | 5.4 | 4.7 | 5.4 | 4.7 | 2.2 | 2.8 |
| Sensitivity | Lower Detection Limit: | |||||||
| 0.3 nmol/l | ||||||||
| 0.19 ng/ml | Lower Detection Limit: | |||||||
| 0.46 nmol/l | ||||||||
| 0.3 ng/ml | ||||||||
| Assay range | ||||||||
| (LDL to high std.) | 0.3 - 10.00 nmol/l | |||||||
| 0.19 - 6.51 ng/ml | 0.46 - 9.22 nmol/l | |||||||
| 0.3 - 6.0 ng/ml |
Continued on next page
4
Image /page/4/Picture/0 description: The image shows a logo with the text "mannheim" vertically aligned on the left side of a black square. Inside the square, there is a white circle with the text "boehringer" inside it. The text is in a sans-serif font and is arranged in a way that the circle surrounds the word.
T
510(k) Summary, Continued
Performance Characteristics: F. Substantial
equivalence,
(cont.)
| Method
Comparison | vs. Enzymun-Test T3 (Cat. # 1360868)
Least Squares:
N = 300
$y = -0.35 + 1.18x$
r = 0.957 | vs. Enzymun-Test T3 (Cat. # 1135287)
Least Squares:
N = 55
$y = 1.13x + 0.02$
r = 0.994 |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| | Passing/Bablok
N = 300
$y = -0.56 + 1.26x$
r = 0.957 | |
| Interfering | No interference up to: | No interference up to: |
| substance:
Hemoglobin
Lipemia
Bilirubin
Biotin | 1 g/dl
1500 mg/dl
25 mg/dl
20 ng/ml | 1 g/dl
1250 mg/dl
65 mg/dl
50 ng/ml |
| Specificity | % cross reaction | % cross reaction |
| D-T3
L-T4
D-T4
L-rT3
L-T2 | 98.9
0.115
0.115
0.007
0.998 | 100
0.16
0.07
0.04
1.0 |
| 3,3',5-tri-
iodothyroacetic acid
3,3',5,5'-tetra-
iodothyroacetic acid | 106.4
0.007 | 7.5
0.01 |
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol of care and protection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 5 1996
LeeAnn Chambers, RAC Program Manager, Regulatory Affairs Boehringer Mannheim Corporation Quality System & Compliance 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re : K962508 Elecsys T3 II Requlatory Class: Product Code: CDP, JIS Dated: July 25, 1996 Received: July 26, 1996
Dear Ms. Chambers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
6
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655 .
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification* (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
V
7
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:
Triiodothyronine (T3) is the hormone principally responsible for the development of the effects of the thyroid hormones on the various target organs.
T3 (3,5,3' Triiodothyronine) is mainly formed extra-thyroidally, particularly in the liver, by enzymatic 5'-deiodination of T4. Accordingly, the T3 concentration in serum is more a reflection of the functional state of the peripheral tissue than the secretory performance of the thyroid gland.
A reduction in the conversion of T4 to T3 results in a fall in the T3 concentration. It occurs under the influence of medications such as propanolol, glucocorticoids or amiodarone and in severe non-thyroidal general diseases - "non-thyroidal illness" (NTI) - and is referred to as the "low T3 syndrome." Like T4, over 99% of T3 is bound to transport proteins, but its affinity to them is around 10-fold lower.1-3,7
The determination of T3 is utilized in the diagnosis of T3-hyperthyroidism, the detection of early stages of hyperthyroidism and for indicating a diagnosis of thyrotoxicosis factitia. 4-6
References
- Wheeler MH, Lazarus JH. Diseases of the Thyroid. Chapman and Hall Medical. London l Glasgow Weinheim New York Tokyo Melbourne Madras 1994;107-115.
- Pfannenstiel P, Saller B. Schilddrüsenkrankheiten Diagnose und Therapie. Berliner 2 Medizinische Verlagsanstalt GmbH 1995; 2:30-32,60-62.
- ﻟﻠﺴﺎ Fisher DA. Physiological variations in thyroid hormones physiological and pathophysiological considerations. Clinical Chemistry 1996;42:135-139.
Continued on next page
นบุ๊กวอ
1
പറവാക
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ala Peitrs
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 5962508
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use
(Optional Format 1-2-96)