ELECSYS TSH ASSAY

K961491 · Boehringer Mannheim Corp. · JLW · Jul 22, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961491
• Device Name: ELECSYS TSH ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Jul 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

Immunoassay for the in vitro quantitative determination of Thyroid Stimulating Hormone in human serum and plasma.

Device Story

Elecsys® TSH Assay is an in vitro diagnostic immunoassay for quantitative TSH measurement in human serum/plasma. Operates on Elecsys® 2010 instrument using electrochemiluminescence (ECL) sandwich principle. Process: 50μL sample incubated with biotinylated monoclonal TSH antibody and ruthenium-labeled monoclonal TSH antibody; streptavidin-coated microparticles added to bind complex; microparticles magnetically captured on electrode; voltage application induces chemiluminescent emission measured by photomultiplier. Results calculated via instrument-specific 2-point calibration curve and master curve from reagent bar code. Used in clinical laboratory settings by trained personnel. Provides quantitative TSH levels to assist clinicians in thyroid function assessment.

Clinical Evidence

Bench testing only. Performance evaluated via precision (N=60 per level, CVs 1.47-3.28%), functional sensitivity (0.01 μU/mL), and linearity (0.01-100 μU/mL). Method comparison against predicate (N=132) showed high correlation (r=0.991). Interference and cross-reactivity studies performed for bilirubin, hemoglobin, lipemia, biotin, RF, HCG, LH, FSH, and HGH.

Technological Characteristics

Electrochemiluminescence immunoassay. Components: biotinylated monoclonal TSH antibody, ruthenium-labeled monoclonal TSH antibody, streptavidin-coated microparticles. Detection: photomultiplier tube measuring chemiluminescent emission upon electrode voltage application. Calibration: 2-point calibration with master curve via reagent bar code. Instrument: Elecsys® 2010.

Indications for Use

Indicated for the in vitro quantitative determination of Thyroid Stimulating Hormone (TSH) in human serum and plasma for clinical diagnostic purposes.

Regulatory Classification

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.

Predicate Devices

• Enzymun-Test® TSH (K915195)

Reference Devices

• Nichols 3rd Generation TSH assay

Submission Summary (Full Text)

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K961491
Diagnostics

JUL 22 1996 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
[phone]
Contact Person: Betsy Soares-Maddox
Date Prepared: April 4, 1996

2. Device name
Proprietary name: Elecsys® TSH Assay
Common name: Electrochemiluminescence assay for the thyroid stimulating hormone.
Classification name: Radioimmunoassay-thyroid stimulating hormone

3. Predicate device
We claim substantial equivalence to the Enzymun-Test® TSH (K915195).

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Diagnostics

# 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)

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Diagnostics

# 510(k) Summary, Continued

## 6. Substantial equivalence, cont.

### Differences:

| 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 | | |

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Diagnostics

# 510(k) Summary, Continued

## 6. Substantial equivalence, cont.

Performance Characteristics:

| 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: | 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 | 30 ng/mL |
| RF | 339 IU/mL | No concentration reported |
| Specificity | Conc % Cross-Reactivity | No Cross-Reactivity detected at: |
| HCG | 200 0 | 200 U/mL |
| LH | 400 0.038 | 200 mU/mL |
| FSH | 400 0.008 | 200 mU/mL |
| HGH | 400 0.00004 | Not reported |

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