TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)

• K Number: K963080
• Device Name: TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
• Manufacturer: BAYER CORP.
• Date Cleared: 1996-09-27 ( 50 days)
• Product Code: CDZ
• Regulation Number: 862.1680

Intended Use

This in vitro method is intended to quantitatively measure testosterone in human servin on a Technicon Immuno 1 system. Measurements of Testosterone are used in the diagnosis and treatment of various hormonal sexual disorders.

Device Description

This document describes the Immuno 1 Testosterone method, an in vitro method for quantitatively measuring testosterone in human serum on a Technicon Immuno 1 system. It compares the performance of this method to a predicate device, the DPC Coat-a-Count Total Testosterone RJA kit, in terms of minimum detection concentration, precision, and correlation. It also provides a specificity comparison by listing the crossreactivity percentages of various substances with both methods.

Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard in vitro diagnostic assay for measuring testosterone and compares its performance to a predicate device using traditional analytical metrics. There is no mention of AI or ML.

Therapeutic

No.
The device measures testosterone levels, which is used in diagnosis and treatment, but the device itself is a diagnostic tool, not one that provides therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "Measurements of Testosterone are used in the diagnosis and treatment of various hormonal sexual disorders." This indicates that the device provides information for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device is described as an "in vitro method" for measuring testosterone on a "Technicon Immuno 1 system," which is a hardware instrument. The summary focuses on the performance of this method compared to a predicate kit, indicating it's a reagent or assay used with a specific hardware system, not a standalone software device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The document explicitly states the intended use is an "in vitro method" to measure testosterone in human serum. This is a key characteristic of an IVD.
• Sample Type: It uses human serum, which is a biological sample taken from the body, another defining feature of an IVD.
• Purpose: The measurements are used in the "diagnosis and treatment of various hormonal sexual disorders," indicating a medical purpose for the test results.
• Device Description: The description reinforces that it's an "in vitro method for quantitatively measuring testosterone in human serum."
• Comparison to Predicate: The comparison to a "predicate device, the DPC Coat-a-Count Total Testosterone RJA kit," which is also an IVD, further confirms the nature of this device.

All these points align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This in vitro method is intended to quantitatively measure testosterone in human servin on a Technicon Immuno 1 system. Measurements of Testosterone are used in the diagnosis and treatment of various hormonal sexual disorders.

Product codes

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Device Description

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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

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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

Comparison of performance between the Immuno 1 Testosterone method and a similar device (DPC Coat-a-Count Total Testosterone RJA kit).

• Correlation: y=0.98x + 0.01 where y=Immuno 1 Total Testosterone method, x=DPC Total Testosterone method, n=335, r=0.990, S =0.41 ng/mL

Key Metrics

• Minimum Det. Conc.: Immuno 1 Testosterone: 0.04 ng/mL; DPC (predicate Device): 0.04 ng/mL
• Precision (Between-Run):
  • Immuno 1 Testosterone: 0.86 ng/mL 6.3%; 3.13 ng/mL 3.5%; 8.58 ng/mL 2.2%
  • DPC (predicate Device): 0.93 ng/mL 12%; 2.64 ng/mL 6.4%; 6.72 ng/mL 6.0%
• Specificity (Crossreactivity %):
  • Aldosterone: Immuno 1: ND, DPC: 0
  • 5β-Androstan-3α,17β-diol: Immuno 1: 0.3, DPC: 0.4
  • Androstenedione: Immuno 1: 0.4, DPC: 0.5
  • 5α-Androstan-3β,17β-diol: Immuno 1: 1.2, DPC: 0.04
  • 5-Androsten-3β,17β-diol: Immuno 1: 0.8, DPC: 0.2
  • 5α-Androstan-3,17-dione: Immuno 1: ND, DPC: 0.05
  • Androsterone: Immuno 1: ND, DPC: 0
  • Corticosterone: Immuno 1: ND, DPC: 0
  • Cortisol: Immuno 1: ND, DPC: 0
  • Cortisone: Immuno 1: ND, DPC: 0
  • Danazol: Immuno 1: ND, DPC: 0.09
  • 11-Deoxycortisol: Immuno 1: ND, DPC: 0
  • Dexamethasone: Immuno 1: ND, DPC: 0
  • DHEA: Immuno 1: ND, DPC: 0
  • DHEA-Sulfate: Immuno 1: ND, DPC: 0.01
  • 5α-Dihydrotestosterone: Immuno 1: 4.7, DPC: 3.3
  • Estradiol: Immuno 1: 0.1, DPC: 0.02
  • 5(10)-Estren-17α-ethynyl-17β-ol-3-One: Immuno 1: ND, DPC: 0.2
  • 4-Estren-7α-methyl-17β-ol-one: Immuno 1: ND, DPC: 1.1
  • 19-Nortestosterone: Immuno 1: 7.6, DPC: 20
  • Estrone: Immuno 1: ND, DPC: 0.01
  • Ethisterone: Immuno 1: 0.5, DPC: 0.7
  • Fluoxymesterone: Immuno 1: ND, DPC: 0.01
  • 19-Hydroxyandrostenedione: Immuno 1: ND, DPC: 2
  • 11-Ketotestosterone: Immuno 1: -1.2, DPC: 16
  • 11β-Hydroxytestosterone: Immuno 1: 14.2, DPC: 0.8
  • Methyltestosterone: Immuno 1: 2.2, DPC: 1.7
  • Norethindrone: Immuno 1: 0.1, DPC: 0.1
  • Prednisone: Immuno 1: ND, DPC: 0
  • Progesterone: Immuno 1: ND, DPC: 0
  • Spironolactone: Immuno 1: ND, DPC: 0
  • Triamicinolone: Immuno 1: -0.1, DPC: 0.2
  • 5α-Androstan-3α-,17β-diol: Immuno 1: 0.2, DPC: NR
  • Desoxycortisone: Immuno 1: ND, DPC: NR
  • Estriol: Immuno 1: ND, DPC: NR
  • 11β-Hydroxyandrostanedione: Immuno 1: ND, DPC: NR
  • 11β-Hydroxyandrostenedione: Immuno 1: ND, DPC: NR
  • 17-Hydroxyprogesterone: Immuno 1: ND, DPC: NR

Predicate Device(s)

DPC Coat-a-Count Total Testosterone RJA kit

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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Regulation Number and Section

§ 862.1680 Testosterone test system.

(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.

Summary

0

SEP 2 7 10

SUMMARY OF SAFETY AND EFFECTIVENESS

Testosterone Method for the Bayer Immuno 1 ° System

Listed below is a comparison of the performance between the Immuno 1 Testosterone method and a similar device that was granted clearance of substantial equivalence (DPC Coat-a-Count Total Testosterone RJA kit). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Testosterone method sheet and the DPC Total Testosterone method sheet.

INTENDED USE

This in vitro method is intended to quantitatively measure testosterone in human servin on a Technicon Immuno 1 system. Measurements of Testosterone are used in the diagnosis and treatment of various hormonal sexual disorders.

| METHOD | Immuno 1
Testosterone | DPC
(predicate Device) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Part No. | Reagents T01-3694-51
Calibrators T03-3695-01 | TKTT1 (100 tubes) |
| Minimum Det. Conc. | 0.04 ng/mL | 0.04 ng/mL |
| Precision (Between-Run) | 0.86 ng/mL 6.3%
3.13 ng/mL 3.5%
8.58 ng/mL 2.2% | 0.93 ng/mL 12%
2.64 ng/mL 6.4%
6.72 ng/mL 6.0% |
| Correlation | y=0.98x + 0.01
where
y=Immuno 1 Total Testosterone method
x=DPC Total Testosterone method
n=335
r=0.990
S =0.41 ng/mL | |

Gabe Muraca Bayer Corporation 511 Benedict Ave Tarrytown, NY 10591 Rev. Date: 09/16/96

1

Specificity

| Crossreactant | Immuno 1
% Crossreactivity | DPC Coat-a-Count
% Crossreactivity |
|---------------------------------------|-------------------------------|---------------------------------------|
| Aldosterone | ND | 0 |
| 5β-Androstan-3α,17β-diol | 0.3 | 0.4 |
| Androstenedione | 0.4 | 0.5 |
| 5α-Androstan-3β,17β-diol | 1.2 | 0.04 |
| 5-Androsten-3β,17β-diol | 0.8 | 0.2 |
| 5α-Androstan-3,17-dione | ND | 0.05 |
| Androsterone | ND | 0 |
| Corticosterone | ND | 0 |
| Cortisol | ND | 0 |
| Cortisone | ND | 0 |
| Danazol | ND | 0.09 |
| 11-Deoxycortisol | ND | 0 |
| Dexamethasone | ND | 0 |
| DHEA | ND | 0 |
| DHEA-Sulfate | ND | 0.01 |
| 5α-Dihydrotestosterone | 4.7 | 3.3 |
| Estradiol | 0.1 | 0.02 |
| 5(10)-Estren-17α-ethynyl-17β-ol-3-One | ND | 0.2 |
| 4-Estren-7α-methyl-17β-ol-one | ND | 1.1 |
| 19-Nortestosterone | 7.6 | 20 |
| Estrone | ND | 0.01 |
| Ethisterone | 0.5 | 0.7 |
| Fluoxymesterone | ND | 0.01 |
| 19-Hydroxyandrostenedione | ND | 2 |
| 11-Ketotestosterone | -1.2 | 16 |
| 11β-Hydroxytestosterone | 14.2 | 0.8 |
| Methyltestosterone | 2.2 | 1.7 |
| Norethindrone | 0.1 | 0.1 |
| Prednisone | ND | 0 |
| Progesterone | ND | 0 |
| Spironolactone | ND | 0 |
| Triamicinolone | -0.1 | 0.2 |
| 5α-Androstan-3α-,17β-diol | 0.2 | NR |
| Desoxycortisone | ND | NR |
| Estriol | ND | NR |
| 11β-Hydroxyandrostanedione | ND | NR |
| 11β-Hydroxyandrostenedione | ND | NR |
| 17-Hydroxyprogesterone | ND | NR |

NR= None reported
ND=None detected

ND=None detected

Gabe Muraca Bayer Corporation 511 Benedict Ave
Tarrytown, NY 10591 Rev. Date: 09/16/96