ELECSYS TESTOSTERONE ASSAY

K964889 · Boehringer Mannheim Corp. · CDZ · Mar 18, 1997 · Clinical Chemistry

Device Facts

• Record ID: K964889
• Device Name: ELECSYS TESTOSTERONE ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Mar 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Intended Use

Immunoassay for the in vitro quantitative determination of testosterone in serum and plasma.

Device Story

Elecsys® Testosterone Assay is an in vitro diagnostic immunoassay for quantitative testosterone measurement in serum and plasma. It utilizes an electrochemiluminescence (ECL) competition principle. Sample is incubated with biotinylated testosterone-specific antibody and ruthenium-labeled testosterone derivative; immunocomplexes form. Streptavidin-coated microparticles bind the complex via biotin-streptavidin interaction. Microparticles are magnetically captured on an electrode in the Elecsys® 2010 instrument. Voltage application induces chemiluminescent emission, measured by a photomultiplier. Results are calculated via a 2-point calibration curve and master curve provided by reagent bar code. The assay provides clinicians with quantitative testosterone levels to aid in the diagnosis and monitoring of testosterone-related conditions.

Clinical Evidence

Bench testing only. Performance compared to RIA predicate (N=71). Precision (within-run and total) reported across low, mid, and high levels. Lower detection limit 0.02 ng/mL. Linearity 0.02-15.00 ng/mL. Method comparison (Passing/Bablok) yielded y = 1.02x - 0.108, r = 0.963. Interference testing performed for bilirubin, hemoglobin, lipemia, and biotin. Specificity evaluated via cross-reactivity testing against various steroids.

Technological Characteristics

Electrochemiluminescence immunoassay. Uses biotinylated testosterone-specific antibody and ruthenium-labeled testosterone derivative. Solid-phase: streptavidin-coated microparticles. Detection: photomultiplier tube measuring chemiluminescence induced by electrode voltage. Instrument: Elecsys® 2010. Calibration: 2-point, master curve via reagent bar code. Connectivity: instrument-specific.

Indications for Use

Indicated for the in vitro quantitative determination of testosterone in human serum and plasma samples.

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

• Coat-A-Count® Total Testosterone Assay (K81340)
• K844423

Submission Summary (Full Text)

{0}

MAR 18 1997
K964889
510(k) Summary
BEEFERIEGER
MANNHEIM
CORPORATION

## 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
P.O. Box 4117
Concord, CA 94524-4117
(510) 674 - 0690 extension 8413
FAX 510 687 - 1850

Contact Person: Yvette Lloyd
Date Prepared: December 5, 1996

### 2. Device name

Proprietary name: Elecsys® Testosterone Assay
Common name: Electrochemiluminescence assay for the determination of testosterone.
Classification name: System, Test, Testosterone

### 3. Predicate device

We claim substantial equivalence to the Coat-A-Count® Total Testosterone Assay (K81340).
(K84423)

Continued on next page

page 27

{1}

510(k) Summary, Continued

4. Device Description

Competition principle. Total duration of assay: 18 minutes.

- 1st incubation (9 min.): 50 µL of sample is incubated with a testosterone-specific biotinylated antibody (55 µL) and a testosterone derivative labeled with a ruthenium complex (55 µL).** The binding sites of the labeled antibody become occupied partly by the sample analyte (depending on its concentration) and partly by the ruthenium-labeled hapten to form the respective immunocomplexes.

- 2nd incubation (9 min.): After addition of streptavidin-coated microparticles (40 µL), the entire complex is 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 2-point calibration and a master curve provided via the reagent bar code.

**Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)²⁺)

5. Intended use

Immunoassay for the in vitro quantitative determination of testosterone in serum and plasma.

6. Comparison to predicate device

The Boehringer Mannheim Elecsys® Testosterone Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Coat-A-Count® Total Testosterone Assay (K81340).

K844423

Continued on next page

{2}

510(k) Summary, Continued

6. Comparison to predicate device, cont.

The following table compares the Elecsys® Testosterone Assay with the predicate device, Coat-A-Count® Total Testosterone Assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device in provided in attachment 6.

Similarities:

- Intended Use: Immunoassay for the in vitro quantitative determination of testosterone
- Sample type: Serum and plasma

Differences:

| Feature | Elecsys® Testosterone | Coat-A-Count® Total Testosterone |
| --- | --- | --- |
| Solid-Phase Binding Principal | Streptavidin/Biotin | Antibody-coated tubes |
| Reaction test principle | Electrochemiluminescence | Radioimmunoassay (RIA) |
| Instrument required | Elecsys® 2010 | Gamma counter |
| 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 required every run |

Continued on next page

{3}

510(k) Summary, Continued

6. Comparison to predicate device, cont.

Performance Characteristics:

| Feature | Elecsys® Testosterone | | | Coat-A-Count® Total Testosterone | | |
| --- | --- | --- | --- | --- | --- | --- |
| Precision | Modified NCCLS (ng/mL): | | | Modified NCCLS (ng/mL): | | |
| Level | Low | Mid | High | Low | Mid | High |
| Within-Run: N | | | | | | |
| Mean | 60 | 60 | 60 | -- | -- | -- |
| %CV | 0.24 | 2.75 | 7.01 | -- | -- | -- |
| Total: N | 4.62 | 1.39 | 1.09 | -- | -- | -- |
| Mean | 60 | 60 | 60 | 20 | 20 | 20 |
| %CV | 0.24 | 2.75 | 7.01 | 0.76 | 2.64 | 6.72 |
| | 7.41 | 2.21 | 1.68 | 11.0 | 6.4 | 6.0 |
| Lower Detection Limit | 0.02 ng/mL | | | 0.04 ng/mL | | |
| Linearity | 0.02-15.00 ng/mL (with a deviation from a linear line of ±10%) | | | 0.04-16.00 ng/mL (with a deviation from a linear line of ±10%) | | |
| Method Comparison | Vs RIA for Testosterone
Least Squares
y = 0.956x + 0.049
r = 0.963
SEE = 0.459
N = 71

Passing/Bablok
y = 1.02 x - 0.108
r = 0.963
SEE = 0.349
N = 71 | | | Vs RIA for Testosterone
Least Squares
y = 1.23x + 0.16
r = 0.987
SEE = ---
N = 83 | | |

Continued on next page

{4}

Premarket Notification, 510(k) for Elecsys® Testosterone, Continued

F. Substantial equivalence, cont.

Performance Characteristics, cont:

| Feature | Elecsys® Testosterone | | Coat-A-Count® Total Testosterone | |
| --- | --- | --- | --- | --- |
| Interfering substances | No interference at: | | No interference at: | |
| Bilirubin | 25 mg/dL | | Not listed | |
| Hemoglobin | 1.0 g/dL | | Not listed | |
| Lipemia | 1500 mg/dL | | Not listed | |
| Biotin | 30 ng/mL | | Not listed | |
| Specificity | Level tested (ng/mL) | %Cross-reactivity | Level tested (ng/mL) | %Cross-reactivity |
| 5-α-Dihydrotestosterone | 40 | 1.89 | 50 | 3.3 |
| 11-Ketotestosterone | 40 | 10.4 | 1.3 | 16 |
| 11-β-Hydroxytestosterone | 40 | 8.34 | 2000 | 0.8 |
| Ethisterone | 40 | 0.02 | 50 | 0.7 |
| 5-Androstene-3β,17β-diol | 40 | 0.30 | 250 | 0.2 |
| Androstenedione | 40 | 0.91 | --- | --- |
| 5-α-Androstan-3β,17β-diol | 40 | 0.51 | 1000 | 0.04 |
| Danazol | 40 | 0.00 | 200 | 0.09 |
| Norgestrel | 40 | 0.00 | --- | --- |
| Estradiol | 40 | 0.00 | 1000 | 0.02 |