3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

• K Number: K981312
• Device Name: 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
• Manufacturer: BAYER CORP.
• Date Cleared: 1998-06-05 ( 56 days)
• Product Code: JLW JIS JJX
• Regulation Number: 862.1690

Intended Use

This in vitro diagnostic method is intended to quantitatively measure thyroid stimulating hormone in human serum or plasma on the Bayer Immuno 1 System. Measurements of TSH, with a 3td Generation sensitivity of <20% total CV at 0.01 uIUmL to 0.02 µIU/mL (as defined by the American Thyroid Association), are used as an aid in the diagnosis of thyroid or pituitary disorders. This diagnostic method is not intended for use on any other system.

Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic assay for measuring TSH levels and does not mention any AI or ML components.

Therapeutic

No
This device is an in vitro diagnostic method intended to quantitatively measure thyroid stimulating hormone in human serum or plasma to aid in the diagnosis of thyroid or pituitary disorders. It identifies a condition but does not treat it.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic method is intended to quantitatively measure thyroid stimulating hormone...Measurements of TSH...are used as an aid in the diagnosis of thyroid or pituitary disorders."

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic method intended for use on a specific hardware system (Bayer Immuno 1 System) and involves the quantitative measurement of a substance in human serum or plasma, indicating it is a reagent or assay kit used with a physical instrument, not a standalone software application.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states:

"This in vitro diagnostic method is intended to quantitatively measure thyroid stimulating hormone in human serum or plasma on the Bayer Immuno 1 System."

This statement clearly identifies the device as an in vitro diagnostic method.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This in vitro diagnostic method is intended to quantitatively measure thyroid stimulating hormone in human serum or plasma on the Bayer Immuno 1 System. Measurements of TSH, with a 3td Generation sensitivity of

Regulation Number and Section

§ 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.

Summary

0

JUN 5 1898

Summary of Safety and Effectiveness

3rd Generation TSH Method for the Bayer Immuno 1™ System

Listed below is a comparison of the performance of the Bayer Immuno 1™ 3rd Generation TSH (3Gen TSH) method and similar devices granted clearance of substantial equivalence (Bayer Immuno 1 TSH Assay, (Chiron) Ciba-Corning ACS™ TSH-3 Assay and (Roche) Boehringer-Mannheim Elecsys® TSH Assay). The information below was extracted from the Bayer Immuno 1 3rd Generation TSH method sheet and Package Inserts from the other three methods.

Intended Use

This in vitro diagnostic method is intended to quantitatively measure thyroid stimulating hormone (TSH) in human serum or plasma with 3d generation sensitivity on the Bayer Immuno 1 System. Measurements of TSH, produced by the anterior pituitary, are used in the diagnosis of thyroid or pituitary disorders.

| Bayer Corporation | | | | Ciba-Corning | | Boehringer-
Mannheim | | |
|-------------------------------------------------|----------------------------|----------------------------|------------------------------|--------------------|--------------------|-------------------------|--------------------|------|
| Bayer Immuno 1 | | ACS:180 | | Elecsys | | | | |
| | 3GEN TSH | TSH | TSH-3 | TSH | | | | |
| Part Number
Reagents
Calibrators | T01-4038-51
T03-4039-01 | T01-2942-51
T03-3568-01 | 570056
(rgnts and calibs) | 1731459
1731483 | | | | |
| Expected Values | 0.31 - 4.7 µIU/mL | 0.47 - 6.9 µIU/mL | 0.35 - 5.5 µIU/mL | 0.25 - 4.2 µIU/mL | | | | |
| Precision (within-run)
(n = 20 over 10 days) | mean | % CV | mean | % CV | mean | % CV | mean | % CV |
| | 0.008 | 12.6 | 0.1 | 8.0 | 0.026 | 10.7 | 0.084 | |
| | 0.019 | 4.1 | 1.3 | 5.5 | 0.077 | 6.5 | 0.091 | 2.1 |
| | 0.031 | 3.7 | 9.0 | 1.7 | 0.668 | 3.9 | 0.34 | 8.6 |
| | 0.50 | 4.0 | 22.5 | 1.6 | 4.81 | 3.3 | 2.45 | 1.9 |
| | 4.68 | 2.8 | | | 33.503 | 3.2 | 3.96 | 1.8 |
| | 29.26 | 1.4 | | | 97.021 | 4.0 | 10.67 | 1.5 |
| | 59.03 | 1.4 | | | | | | |
| Precision (total)
(n = 20 over 10 days) | 0.008 | 12.6 | 0.1 | 13.0 | 0.026 | 15.8 | 0.084 | 5.4 |
| | 0.019 | 5.1 | 1.3 | 6.3 | 0.077 | 8.4 | 0.091 | 3.3 |
| | 0.031 | 3.7 | 9.0 | 2.0 | 0.668 | 4.1 | 0.34 | 8.7 |
| | 0.50 | 4.2 | 22.5 | 1.8 | 4.810 | 3.5 | 2.45 | 2.2 |
| | 4.68 | 3.1 | | | 33.503 | 3.9 | 3.96 | 3.6 |
| | 29.26 | 4.1 | | | 97.021 | 5.0 | 10.67 | 1.8 |
| | 59.03 | 1.8 | | | | | | |
| Regression Equation | | | y = 0.980x - 0.011 | | y = 0.928x - 0.021 | | y = 0.988x - 0.122 | |
| where:
y = | 3Gen TSH | | | | | | | |
| x = | | | TSH (2nd Gen) | | ACS:180 | | Elecsys | |
| n = | | | 218 | | 203 | | 56 | |
| r = | | | 0.998 | | 0.996 | | 0.997 | |
| Sy.x = | | | 1.655 | | 0.676 | | 1.049 | |
| range = | | | 0.05 - 104.5 | | 0.01 - 68.1 | | 0.01 - 65.3 | |

1

Specificity: Cross Reactants Spiked into Normal Human Serum Pools.

| Compound | Test Concentration
(µIU/mL) | Crossreactivity
(%) |
|------------------------------------|--------------------------------|------------------------|
| human Chorionic Gonadotropin (hCG) | 250,000 |