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

K963080 · Bayer Corp. · CDZ · Sep 27, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963080
• Device Name: TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
• Applicant: Bayer Corp.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Sep 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Intended Use

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

Device Story

The Immuno 1 Testosterone method is an in vitro diagnostic assay for the Technicon Immuno 1 system. It measures testosterone levels in human serum samples. The system processes samples to provide quantitative results, which clinicians use to diagnose and manage hormonal sexual disorders. The device operates in a clinical laboratory setting, managed by laboratory technicians or medical professionals. The output is a numerical concentration value (ng/mL), which informs clinical decision-making regarding patient hormonal status and treatment efficacy.

Clinical Evidence

Bench testing only. Performance compared to DPC Coat-a-Count RIA kit using 335 serum samples. Correlation: y=0.98x + 0.01, r=0.990, Syx=0.41 ng/mL. Precision (between-run) reported at three concentration levels (0.86, 3.13, 8.58 ng/mL) with CVs ranging from 2.2% to 6.3%. Specificity evaluated against various cross-reactants.

Technological Characteristics

In vitro diagnostic immunoassay reagents and calibrators for use on the Technicon Immuno 1 system. Quantitative measurement principle. Minimum detectable concentration 0.04 ng/mL.

Indications for Use

Indicated for the quantitative measurement of testosterone in human serum to aid in the diagnosis and treatment of hormonal sexual disorders.

Regulatory Classification

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.

Predicate Devices

• DPC Coat-a-Count Total Testosterone RIA kit (TKTT1)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS

K-963080

# Testosterone Method for the Bayer Immuno 1® System

SEP 27 1996

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 RIA 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 serum 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_{yx}=0.41 ng/mL | |

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

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# 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-3-0ne | 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-Hydroxy testosterone | 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-Hydroxyandrostenedione | ND | NR |
| 11β-Hydroxyandrostenedione | ND | NR |
| 17-Hydroxyprogesterone | ND | NR |

NR= None reported
ND=None detected

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