Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunoassay based on competitive binding and electrochemiluminescence detection. There is no mention of AI, ML, or any related computational techniques for data analysis or interpretation beyond standard calibration curve generation.

Therapeutic

No
This device is an immunoassay designed for the quantitative determination of testosterone levels, used in the diagnosis and treatment of various disorders, rather than directly providing a therapeutic effect.

Diagnostic

Yes

The intended use explicitly states that measurements of testosterone are "used in the diagnosis and treatment of disorders."

SaMD (Software as a Medical Device)

No

The device description clearly states it is an immunoassay based on a competitive test principle with streptavidin-coated microparticles and electrochemiluminescence detection, and includes a reagent kit. This indicates a physical, hardware-based device and associated reagents, not a software-only device.

IVD (In Vitro Diagnostic)

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

The "Intended Use / Indications for Use" section explicitly states: "Immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma." The phrase "in vitro" is the key indicator that this device is intended for use outside of the living body, which is the definition of an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

Measurements 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.

Product codes

CDZ

Device Description

The Elecsys Testosterone II immunoassay is based on a competitive test principle with streptavidin-coated microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code. The Elecsys Testosterone II reagent kit consists of a Reagent Pack (R1, R2, and M[Streptavidin-coated microparticles]).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Four method comparison studies were performed to demonstrate the accuracy of the Elecsys Testosterone II assay.

(1) Isotope dilution/liquid chromatographic-tandem mass spectrometry (ID/LC-MS/MS) was validated against the reference method, isotope-dilution/gas chromatography- mass spectrometry (ID-GC/MS).
A total of 52 serum samples with testosterone values ranging from 8 to 1383 ng/dL were measured.
Deming Regression: n=52, Range=8-1383 ng/dL, Slope=1.024, y-int=-0.060, Correlation Coefficient r=0.996

(2) The Elecsys Testosterone II assay was compared to the ID-GC/MS reference method.
A total of 55 serum samples with testosterone values ranging from 7.6 to 1383 ng/dL were measured.
Deming Regression: n=55, Range=7.6-1383 ng/dL, Slope=1.032, y-int=-0.055, Correlation Coefficient r=0.999

(3) The Elecsys Testosterone II assay was compared to the validated ID/LC-MS/MS method.
A total of 142 female serum samples with testosterone values ranging from 3 - 517 ng/dL were measured.
Deming Regression: n=142, Range=3-517 ng/dL, Slope=0.928, y-int=0.047, Correlation Coefficient r=0.959

(4) The Elecsys Testosterone II assay was compared to the predicate device, the Elecsys Testosterone assay (K964889).
A total of 239 male and 148 female serum samples with testosterone values ranging from 6.3 – 1400 ng/dL and 2.5 – 926 ng/dL, respectively, were measured in singlicate.
Male samples: Deming Regression: n=239, Range=6.3-1400 ng/dL, Slope=0.971, y-int=0.085, Correlation Coefficient r=0.985
Female samples: Deming Regression: n=148, Range=2.5-926 ng/dL, Slope=0.984, y-int=-7.34, Correlation Coefficient r=0.972
Male and Female Samples Combined: Deming Regression: n=387, Range=2.5-1400 ng/dL, Slope=0.989, y-int=-2.87, Correlation Coefficient r=0.992

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Precision:
Elecsys 2010:
Intermediate Precision (Total)
18.5% CV @ 4.5 ng/dL
8.4% CV @ 9.5 ng/dL
3.2% CV @ 69.1 ng/dL
2.8% CV @ 216 ng/dL
2.8% CV @ 867 ng/dL
3.4% CV @ 1300 ng/dL
2.4% CV @ 1450 ng/dL

Repeatability (Within-Run)
10.2% CV @ 4.5 ng/dL
4.7% CV @ 9.5 ng/dL
2.1% CV @ 69.1 ng/dL
1.9% CV @ 216 ng/dL
2.6% CV @ 867 ng/dL
1.2% CV @ 1300 ng/dL
1.5% CV @ 1450 ng/dL

LoQ (Functional Sensitivity): 12.0 ng/dL
LoB (Limit of Blank): 1.2 ng/dL
LoD (Limit of Detection): 2.5 ng/dL

Predicate Device(s)

K964889

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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

093421

Elecsys® Testosterone II Immunoassay

:

Confidential

510(k) Summary	APR 2 8 2010
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.
Submitter
Name, Address,
Contact	Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250

Contact person: Sarah Baumann
Phone: (317) 521-3952
Fax: (317) 521-2324
Email: sarah.baumann@roche.com

Secondary contact: Stephanie Greeman
Phone: (317) 521-2458
Fax: (317) 521-2324
Email: stephanie.greeman@roche.com

Date Prepared: October 23, 2009 |
| Device Name | Proprietary name: Elecsys® Testosterone II Immunoassay
Common name: Testosterone II Assay
Classification name: Testosterone Test System |
| Device
Description | The Elecsys Testosterone II immunoassay is based on a competitive test
principle with streptavidin-coated microparticles and
electrochemiluminescence detection. Results are determined using a
calibration curve that is generated specifically on each instrument by a 2-point
calibration and a master curve provided with the reagent bar code.
The Elecsys Testosterone II reagent kit consists of a Reagent Pack (R1, R2,
and M[Streptavidin-coated microparticles]). |
| Substantial
Equivalence | The Elecsys Testosterone II Test System is substantially equivalent to other
devices legally marketed in the United States. We claim equivalency to the
currently marketed Elecsys Testosterone Assay (K964889). |

.

,

:

.

1

The following table compares the Elecsys Testosterone II Immunoassay with Substantial Equivalencethe predicate device. Comparison

Table 1. Testosterone Immunoassay Comparison
Feature	Elecsys Testosterone II Assay	Predicate Device
Elecsys Testosterone Assay
(K964889)
Intended Use	Immunoassay for the in vitro
quantitative determination of
testosterone in human serum and
plasma. The electrochemiluminescence
immunoassay "ECLIA" is intended for
use on Elecsys and cobas e
immunoassay analyzers.	Immunoassay for the in vitro
quantitative determination of
testosterone in human serum
and plasma. The
electrochemiluminescence
immunoassay "ECLIA" is
intended for use on the
Boehringer Mannheim Elecsys
1010 and 2010 immunoassay
analyzers.
Indications for
Use	Measurements 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.	Same
Assay Protocol	Competition principle	Same
Detection Protocol	Electrochemiluminescence
immunoassay (ECLIA)	Same
Traceability/
Standardization	ID-GC/MS (Isotope Dilution Gas-
Chromatography/Mass Spectrometry)	Same
Sample Type	Human serum and plasma	Same
Table 1. Testosterone Immunoassay Comparison, continued
Feature	Elecsys Testosterone II Assay	Predicate Device
Elecsys Testosterone Assay
(K964889)
Instrument
Platform	Elecsys 2010
(Request for CLIA categorization
has been made to add the
MODULAR ANALYTICS E170,
cobas e 411, and cobas e 601
analyzers according to the
Replacement Reagent and
Instrument Policy).	Elecsys 2010
(Elecsys 1010, MODULAR
ANALYTICS E170, cobas e 411,
and cobas e 601 analyzers added
subsequent to clearance)
Measuring Range	2.5 – 1500 ng/dL
(0.087 – 52.0 nmol/L)	2.0 – 1500 ng/dL
(0.069 – 52.0 nmol/L)
Calibrator	Testosterone II CalSet II
Calibrators 1 and 2
The stability, value assignment and
matrix is identical to Testosterone
CalSet II (cleared on K003411).	Same
Calibration
Interval	Once per reagent lot and
• After 1 month (28 days) when
using the same reagent lot
• After 7 days (when using the
same reagent kit on the analyzer)
• As required: e.g. quality control
findings outside the specified
limits	Same
Controls	PreciControl Universal 1 and 2
(cleared on K090541)	Same
Reagent Stability	• Unopened at 2-8°C – up to the
expiration date	• Same
	• After opening at 2-8°C – 12 weeks	• After opening at 2-8°C – 8 weeks
	• Onboard the analyzer – 8 weeks	• Same
Table 2. Testosterone Immunoassay Performance Comparison
Feature	Elecsys Testosterone II Assay	Predicate Device
Elecsys Testosterone Assay
(K964889)
Precision	Elecsys 2010:

Intermediate Precision (Total)
18.5% CV @ 4.5 ng/dL
8.4% CV @ 9.5 ng/dL
3.2% CV @ 69.1 ng/dL
2.8% CV @ 216 ng/dL
2.8% CV @ 867 ng/dL
3.4% CV @ 1300 ng/dL
2.4% CV @ 1450 ng/dL

Repeatability (Within-Run)
10.2% CV @ 4.5 ng/dL
4.7% CV @ 9.5 ng/dL
2.1% CV @ 69.1 ng/dL
1.9% CV @ 216 ng/dL
2.6% CV @ 867 ng/dL
1.2% CV @ 1300 ng/dL
1.5% CV @ 1450 ng/dL | Elecsys 2010:

Intermediate Precision (Total)
7.4% CV @ 24 ng/dL
2.6% CV @ 195 ng/dL
2.2% CV @ 275 ng/dL
1.6% CV @ 620 ng/dL
1.7% CV @ 701 ng/dL

• Bilirubin: 5 mg/day), no sample should be taken until at least 8 hours after the last biotin administration. | • In patients receiving therapy with high biotin doses (i.e. > 5 mg/day), no sample should be taken until at least 8 hours after the last biotin administration. |
| | • No interference was observed from rheumatoid factors up to a concentration of 1000 IU/mL. | |
| | • In vitro tests were performed with 18 commonly used pharmaceuticals. No interference with the assay was found. | • In vitro tests were performed with 16 commonly used pharmaceuticals. No interference with the assay was found. |
| | • Three additional drugs were tested: heparin clexane, dexamethasone, and Nandrolone. A strong interaction with Nandrolone was found. Do not use samples from patients under Nandrolone treatment. | |
| | • In isolated cases, elevated testosterone levels can be seen in samples from female patients with end stage renal disease (ESRD). | |

2

Substantial Equivalence-Comparison (continued)

The following table compares the Elecsys Testosterone II Immunoassay with the predicate device.

3

The following table compares the performance of the Elecsys Testosterone II Substantial Equivalence-Immunoassay with the predicate device. Comparison (continued)

4

The following table compares the performance of the Elecsys Testosterone II Substantial Equivalence-Immunoassay with the predicate device. Comparison (continued)

5

:

The following table compares the performance of the Elecsys Testosterone II Substantial Equivalence-Immunoassay with the predicate device. Comparison (continued)

Table 2. Testosterone Immunoassay Performance Comparison, continued
Feature	Elecsys Testosterone II Assay	Predicate Device
Elecsys Testosterone Assay
(K964889)
Limitations, continued	In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur. These effects are minimized by suitable test design. For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings. Implausible elevated values in female samples should be verified by an extraction method or validated LC-MS/MS tandem method.	In rare cases interference due to extremely high titers of antibodies to streptavidin can occur. The risk of interference from potential immunological interactions between test components and rare sera have been minimized by the inclusion of suitable additives. For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.

6

The following table compares the performance of the Elecsys Testosterone II Substantial Immunoassay with the predicate device. Equivalence-Comparison (continued)

Table 2. Testosterone Immunoassay Performance Comparison, continued
Feature	Elecsys Testosterone II Assay	Predicate Device
Elecsys Testosterone Assay
(K964889)
Method
Comparison	Four method comparison studies were
performed to demonstrate the accuracy
of the Elecsys Testosterone II assay.

(1) Isotope dilution/liquid
chromatographic-tandem mass
spectrometry (ID/LC-MS/MS) was
validated against the reference method,
isotope-dilution/gas chromatography-
mass spectrometry (ID-GC/MS).

A total of 52 serum samples with
testosterone values ranging from 8 to
1383 ng/dL were measured.

The following table summarizes the
results. | The Elecsys Testosterone assay was
compared to the Coat-A-Count®
Total Testosterone Assay.

A total of 71 clinical samples with
testosterone values ranging from
20 – 1269 ng/dL were tested in
singlicate.

The following table summarizes the
results. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Deming Regression n 52 Range 8-1383 ng/dL Slope 1.024 y-int -0.060 Correlation
Coefficient r = 0.996 | | | | | | | | | | | | | Passing/Bablok Least Squares n 71 71 Range 20-1269 ng/dL 20-1269 ng/dL Slope 1.02 0.956 y-int -0.108 0.049 tau/r 0.963 0.963 | | | | | | | | | | | | | | | | | | |

7

The following table compares the performance of the Elecsys Testosterone II Substantial Equivalence-Immunoassay with the predicate device. Comparison (continued)

| Feature | Elecsys Testosterone II Assay | Predicate Device
Elecsys Testosterone Assay
(K964889) | | | | | | | | | | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| Method
Comparison
continued | (2) The Elecsys Testosterone II assay was
compared to the ID-GC/MS reference method.

A total of 55 serum samples with testosterone
values ranging from 7.6 to 1383 ng/dL were
measured.

The following table summarizes the results.
Deming Regression n 55 Range 7.6-1383 ng/dL Slope 1.032 y-int -0.055 Correlation
Coefficient r = 0.999 | | | | | | | | | | | | | |
| | (3) The Elecsys Testosterone II assay was
compared to the validated ID/LC-MS/MS
method.

A total of 142 female serum samples with
testosterone values ranging from
3 - 517 ng/dL were measured.

The following table summarizes the results.
Deming Regression n 142 Range 3-517 ng/dL Slope 0.928 y-int 0.047 Correlation
Coefficient r = 0.959 | | | | | | | | | | | | | |

8

The following table compares the performance of the Elecsys Testosterone II Substantial Equivalence-Immunoassay with the predicate device. Comparison (continued)

Table 2. Testosterone Immunoassay Performance Comparison, continued
Feature	Elecsys Testosterone II Assay	Predicate Device
Elecsys Testosterone Assay (K964889)
Method Comparison continued	(4) The Elecsys Testosterone II assay was compared to the predicate device, the Elecsys Testosterone assay (K964889).

A total of 239 male and 148 female serum samples with testosterone values ranging from 6.3 – 1400 ng/dL and 2.5 – 926 ng/dL, respectively, were measured in singlicate.

The following tables summarize the results. | | | | | | | | | | | | | |
| | Male samples | | | | | | | | | | | | | |
| | Deming Regression n 239 Range 6.3-1400 ng/dL Slope 0.971 y-int 0.085 Correlation Coefficient r = 0.985 | | | | | | | | | | | | | |
| | Female samples | | | | | | | | | | | | | |
| | Deming Regression n 148 Range 2.5-926 ng/dL Slope 0.984 y-int -7.34 Correlation Coefficient r = 0.972 | | | | | | | | | | | | | |
| | Male and Female Samples Combined | | | | | | | | | | | | | |
| | Deming Regression n 387 Range 2.5-1400 ng/dL Slope 0.989 y-int -2.87 Correlation Coefficient r = 0.992 | | | | | | | | | | | | | |

9

Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, represented by a series of stylized lines.

Roche Diagnostics Corporation c/o Sarah Baumann 9115 Hague Road P.O.Box 50410 Indianapolis, IN 46250

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring. MD 20993-0002

APR 2 3 2010

Re: K093421

Trade Name: Elecsys® Testosterone II Assay Regulation Number: 21 CFR §862.1680 Regulation Name: Testosterone test system Regulatory Class: Class I, reserved Product Codes: CDZ Dated: April 19, 2010 Received: April 20, 2010

Dear Ms. Baumann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

10

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

CA

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

11

Indication for Use

510(k) Number (if known): K093421

8 Device Name: Elecsys Testosterone II Assay

Indication For Use:

Immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

Measurements 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 androgenital syndromes.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation' and Safety (OIVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K09342/