(95 days)
No
The device description details a standard immunoassay based on chemical reactions and light measurement, with results determined by a calibration curve. There is no mention of AI or ML in the description, performance studies, or key metrics.
No
This device is for in vitro quantitative determination of TSH, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as an "Immunoassay for the in vitro quantitative determination of Thyroid Stimulating Hormone in human serum and plasma," which directly indicates its use in measuring a biological marker (TSH) to aid in diagnosis. Also, the section "Intended Use / Indications for Use" points to its diagnostic purpose.
No
The device description details a complex immunoassay process involving chemical reactions, microparticles, magnetic capture, and chemiluminescent emission measured by a photomultiplier, indicating significant hardware components are involved.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" explicitly states: "Immunoassay for the in vitro quantitative determination of Thyroid Stimulating Hormone in human serum and plasma."
The term "in vitro" is a key indicator that the device is intended for use outside of a living organism, typically in a laboratory setting, to examine specimens from the human body. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of Thyroid Stimulating Hormone in human serum and plasma.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Sandwich principle: Total duration of assay: 18 minutes (37°C).
• 1st Incubation (9 minutes): Sample (50µL), a biotinylated monoclonal TSH- specific antibody (60 µL), and a monoclonal TSH-specific antibody labeled with a ruthenium complex (50 µL) react to form a sandwich complex.
• 2nd Incubation (9 minutes): After addition of streptavidin-coated microparticles (40 µL) the complex becomes 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 a 2-point calibration curve 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)
Performance Characteristics:
Precision: Modified NCCLS (µU/ml )
Elecsys® TSH: Sample Control 1 (N=60, Within-Run=0.914, %CV=2.08, Total=0.914, %CV=3.28); Control 2 (N=60, Within-Run=2.451, %CV=1.88, Total=2.451, %CV=2.20); Control 3 (N=60, Within-Run=10.670, %CV=1.47, Total=10.670, %CV=1.76).
Enzymun-Test® TSH: Low (N=120, Within-Run=0.09, %CV=20.0, Total=0.09, %CV=48.9); Mid (N=120, Within-Run=1.23, %CV=2.7, Total=1.23, %CV=5.2); High (N=120, Within-Run=23.13, %CV=2.6, Total=23.13, %CV=4.6).
Linearity: Elecsys® TSH: 0.01 µU/mL - 100 µU/mL (within ±10% deviation from the linear line). Enzymun-Test® TSH: 0.03 µU/mL - 40.00 µU/mL (within ±10% deviation from the linear line).
Method Comparison:
Vs Enzymun-Test® TSH (N=132): Least Squares: y = 1.09x + 0.14, r = 0.991, SEE = 0.798. Passing/Bablok: y = 1.12X - 0.05, r = 0.991, SEE = 0.798.
Vs Nichols 3rd Generation (N=142): Least Squares: y = 1.02x - 0.24, r = 0.985, SEE = 1.12.
Interfering substances: No interference at: Bilirubin 25 mg/dL, Hemoglobin 1 g/dL, Lipemia 1500 mg/dL, Biotin 30 ng/mL, RF 339 IU/mL for Elecsys® TSH. For Enzymun-Test® TSH: 64.5 mg/dL, 1 g/dL, 1250 mg/dL, 30 ng/mL, No concentration reported for RF.
Specificity: For Elecsys® TSH: HCG 200 (Conc=200, % Cross-Reactivity=0), LH 400 (Conc=400, % Cross-Reactivity=0.038), FSH 400 (Conc=400, % Cross-Reactivity=0.008), HGH 400 (Conc=400, % Cross-Reactivity=0.00004). For Enzymun-Test® TSH: No Cross-Reactivity detected at: 200 U/mL (HCG), 200 mU/mL (LH), 200 mU/mL (FSH), Not reported (HGH).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: Functional Sensitivity: 0.01 µU/ml, Lower Detection Limit 0.005 µU/mL for Elecsys® TSH. Lower Detection Limit: 0.03 µU/ml for Enzymun-Test® TSH.
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® TSH (K915195)
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
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for Boehringer Diagnostics. The logo consists of the word "Diagnostics" in a serif font, next to a black square containing the words "boehringer mannheim" in white, with the word "boehringer" inside of a white circle. The logo is simple and professional.
JUL 22 1996 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.
- Submitter name, address, contact
Boehringer Mannheim Corporation 2400 Bisso Lane Concord, CA 94524-4117 (510) 674-0667
Contact Person: Betsy Soares-Maddox
Date Prepared: April 4, 1996
- Device name Proprietary name: Elecsys® TSH Assay
Common name: Electrochemiluminescence assay for the thyroid stimulating hormone.
Classification name: Radioimmunoassay-thyroid stimulating hormone
- Predicate device
We claim substantial equivalence tc the Enzymun-Test® TSH (K915195).
Continued on next page
1
Image /page/1/Picture/0 description: The image shows the logo for Boehringer Diagnostics. The logo consists of a black square with a white circle inside. The word "boehringer" is written inside the circle, and the word "mannheim" is written vertically along the left side of the square. To the right of the logo, the word "Diagnostics" is written in a serif font.
510(k) Summary, Continued
| 4.
Device
Description | Sandwich principle: Total duration of assay: 18 minutes (37°C).
• 1st Incubation (9 minutes): Sample (50µL), a biotinylated monoclonal TSH-
specific antibody (60 µL), and a monoclonal TSH-specific antibody labeled
with a ruthenium complex (50 µL) react to form a sandwich complex.
• 2nd Incubation (9 minutes): After addition of streptavidin-coated
microparticles (40 µL) the complex becomes 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 a 2-point calibration curve and a master curve
provided via the reagent bar code. |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.
Intended use | Immunoassay for the in vitro quantitative determination of Thyroid
Stimulating Hormone in human serum and plasma. |
| 6.
Comparison
to predicate
device | The Boehringer Mannheim Elecsys® TSH 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® TSH.
The following table compares the Elecsys® TSH with the predicate device,
Enzymun-Test® TSH.
Similarities:
• Intended Use: Immunoassay for the in vitro quantitative determination of
Thyroid Stimulating Hormone
• Sample type: Serum and plasma
• Antibody: Mouse Monoclonal anti-TSH
• Solid phase binding principle: Streptavidin/Biotin
• Assay standardization: World Health Organization (WHO) |
page
2
Image /page/2/Picture/0 description: The image shows the logo for Boehringer Diagnostics. The logo consists of two parts: a square with the word "mannheim" written vertically on the left side and the word "boehringer" written inside a circle on the right side, and the word "Diagnostics" written in a cursive font on the right side of the square. The logo is black and white.
510(k) Summary, Continued
Differences:
Substantial equivalence,
cont.
| Feature | Elecsys® TSH | Enzymun-Test® TSH |
|---|---|---|
| Reaction test | ||
| principle | Electrochemiluminescence | ELISA/1-step sandwich assay |
| using streptavidin technology | ||
| Instrument | ||
| required | Elecsys® 2010 | ES 300 |
| Assay Range | Reportable Range: | |
| 0.01 μU/ml - 100 μU/ml | Reportable Range: | |
| 0.03 μU/ml - 40.00 μU/ml | ||
| 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 is required every 2 | |
| weeks |
Performance Characteristics:
| Feature | Elecsys® TSH | Enzymun-Test® TSH |
|---|---|---|
| Precision | Modified NCCLS (µU/ml ): | Modified NCCLS (µU/ml ): |
| Level | Sample Control 1 Control 2 | Low Mid High |
| N | 60 60 60 | 120 120 120 |
| Within-Run | 0.914 2.451 10.670 | 0.09 1.23 23.13 |
| %CV | 2.08 1.88 1.47 | 20.0 2.7 2.6 |
| Total | 0.914 2.451 10.670 | 0.09 1.23 23.13 |
| %CV | 3.28 2.20 1.76 | 48.9 5.2 4.6 |
| Sensitivity | Functional Sensitivity: | |
| 0.01 µU/ml |
Lower Detection Limit
0.005 µU/mL | Lower Detection Limit:
0.03 µU/ml |
Continued on next page
3
Image /page/3/Picture/0 description: The image shows the logo for Boehringer Diagnostics. The logo consists of the word "mannheim" written vertically on the left side of a black square. Inside the square is a white circle with the word "boehringer" written inside. To the right of the square is the word "Diagnostics".
510(k) Summary, Continued
Substantial equivalence,
Performance Characteristics:
cont.
| Feature | Elecsys® TSH | Enzymun-Test® TSH | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Linearity | 0.01 µU/mL - 100 µU/mL | ||||||||||||||||
| (within ±10% deviation from the linear line) | 0.03 µU/mL - 40.00 µU/mL | ||||||||||||||||
| (within ±10% deviation from the linear line) | |||||||||||||||||
| Method | |||||||||||||||||
| Comparison | Vs Enzymun-Test® TSH | ||||||||||||||||
| Least Squares: | |||||||||||||||||
| $y = 1.09x + 0.14$ | |||||||||||||||||
| $r = 0.991$ | |||||||||||||||||
| $SEE = 0.798$ | |||||||||||||||||
| $N = 132$ |
Passing/Bablok
$y = 1.12X - 0.05$
$r = 0.991$
$SEE = 0.798$
N=132 | Vs Nichols 3rd Generation
Least Squares:
$y = 1.02x - 0.24$
$r = 0.985$
$SEE = 1.12$
N= 142 | | | | | | | | | | | | | | | |
| Interfering
substances | No interference at:
Bilirubin 25 mg/dL
Hemoglobin 1 g/dL
Lipemia 1500 mg/dL
Biotin 30 ng/mL
RF 339 IU/mL | No interference at:
64.5 mg/dL
1 g/dL
1250 mg/dL
30 ng/mL
No concentration reported | | | | | | | | | | | | | | | |
| Specificity | Conc % Cross-Reactivity HCG 200 0 LH 400 0.038 FSH 400 0.008 HGH 400 0.00004 | | | | | | | | | | | | | | | | No Cross-Reactivity detected at:
200 U/mL
200 mU/mL
200 mU/mL
Not reported |