(338 days)
Not Found
No
The summary describes a standard immunoassay using electrochemiluminescence and a calibration curve, with no mention of AI or ML in the device description, performance studies, or key metrics.
No
This device is an in vitro diagnostic immunoassay used to measure testosterone levels, aiding in diagnosis but not directly treating conditions.
Yes
The device is an immunoassay for the quantitative determination of testosterone, and the measurement results are explicitly stated as being "used in the diagnosis and treatment of disorders."
No
The device description clearly outlines a physical reagent kit (Reagent Pack with R1, R2, and M) and its use on a specific hardware analyzer (cobas e 601). This indicates it is a hardware-based immunoassay system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
- Sample Type: It analyzes human serum and plasma, which are biological samples taken from the body.
- Purpose: The measurements are used in the "diagnosis and treatment of disorders," which is a diagnostic purpose.
- Device Description: It describes a laboratory-based immunoassay using reagents and an analyzer, typical of IVD devices.
N/A
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 the cobas e 601 immunoassay analyzer. 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) due to tumors, polycystic ovaries, and adrenogenital syndromes.
Product codes
CDZ
Device Description
The Elecsys Testosterone II immunoassay makes use of a competitive test principle using streptavidin-coated microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2point calibration and 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)
Non-clinical performance studies:
- Precision (5-Day and 21-Day) according to CLSI EP5-A3.
- 21-Day Precision: evaluated on one cobas e 601 analyzer according to CLSI guideline EP05-A3. Protocol involved testing 2 replicates of 2 controls and 5 samples, 2 runs per day over 21 days using 1 reagent lot. Repeatability and intermediate precision were calculated.
- 5-Day Precision: evaluated on one cobas e 601 analyzer according to CLSI guideline EP05-A3. Protocol involved testing 5 aliquots of each control (PreciControl Universal Level 1 and Level 2) and human serum samples per run, 1 run per day for 5 days with 3 lots. Repeatability and intermediate precision were calculated.
- Analytical Sensitivity: LoB, LoD and LoQ according to CLSI EP17-A2.
- Linearity according to CLSI EP6-A.
- One lot tested on one cobas e 601 with one run. One human serum sample with high analyte content above the measuring range diluted to the lower end with various amounts of human serum sample without analyte content. Dilution series contained 25 steps, samples assayed in 3-fold determinations.
- Endogenous Interferences Hemoglobin, Intralipid, Bilirubin, and Rheumatoid Factors.
- Biotin Interference (CLSI EP07-A3).
- One aliquot of each testosterone sample spiked with biotin up to 3600 ng/mL. Another aliquot spiked with same volume of interfering endogenous substance (without interfering substance). Recovery calculated. Data supports biotin interference claim of to
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 6, 2022
Roche Diagnostics Justin Davis Regulatory Affairs Manager 9115 Hague Road, PO Box 50416 Indianapolis, Indiana 46250
Re: K211685
Trade/Device Name: Elecsys Testosterone II Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone Test System Regulatory Class: Class I, reserved Product Code: CDZ Dated: February 4, 2022 Received: February 7, 2022
Dear Justin Davis:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211685
Device Name
Elecsys Testosterone II
Indications for Use (Describe)
Immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.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) due to tumors, polycystic ovaries, and adrenogenital syndromes.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Elecsys Testosterone II 510(k) Summary
K211685
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).
The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the Elecsys Testosterone II on the cobas e 601.
| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0457 | |
| Contact | Justin Davis |
| Phone: (317) 521-6204 | |
| Email: justin.davis@roche.com | |
| Date Prepared | May 27, 2021 |
| Proprietary Name | Elecsys Testosterone II |
| Common Name | Testosterone II Assay |
| Classification Name | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Product Codes, | |
| Regulation Numbers | CDZ |
| 21 CFR 862.1680 | |
| Predicate Devices | Elecsys Testosterone II (K093421) |
| Establishment Registration | Roche Diagnostics GmbH Mannheim, Germany: 9610126 |
| Roche Diagnostics GmbH Penzberg, Germany: 9610529 | |
| Roche Diagnostics Indianapolis, IN United States: 1823260 |
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1. DEVICE DESCRIPTION
The Elecsys Testosterone II immunoassay makes use of a competitive test principle using streptavidin-coated microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2point calibration and 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)).
2. 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 the cobas e 601 immunoassay analyzer.
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.
TECHNOLOGICAL CHARACTERISTICS 3.
The reagent working solutions include:
Rack Pack (kit placed on the analyzer).
- . M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidincoated microparticles 0.72 mg/mL; preservative.
- R1 Anti-testosterone-Ab~biotin (gray cap), 1 bottle, 10 mL: Biotinylated monoclonal . anti-testosterone antibody (sheep) 40 ng/mL: releasing reagent 2-bromoestradiol: MES buffer 50 mmol/L, pH 6.0; preservative.
- R2 Testosterone-peptide~Ru(bpy)=+ (black cap), 1 bottle, 9 mL: Testosterone derivative, . labeled with ruthenium complex 1.5 ng/mL; MES buffer 50 mmol/L, pH 6.0; preservative.
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The following table compares the updated Elecsys Testosterone II with its predicate device, the current Elecsys Testosterone II (K093421).
| Feature | Candidate Device
Elecsys Testosterone II (K211685) | Predicate Device
Elecsys Testosterone II (K093421) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| 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 the cobas e 601 immunoassay analyzer | Same |
| 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 Method | Competitive Principle | Same |
| Detection
Method | Electrochemiluminescence immunoassay
(ECLIA) | Same |
| Instrument
Platform | cobas e 601 | Same |
| Sample
Type/Matrix | Human serum, plasma | Same |
| Traceability/
Standardization | ID-GC/MS ("Isotope Dilution - Gas
Chromatography/Mass Spectrometry"). | Same |
| Sample
Anticoagulants | Li-heparin, K2-EDTA and K3-EDTA
plasma. | Same |
| Calibrator | Testosterone II CalSet II
Calibrators 1 and 2 | Same |
| Calibration
Method | Traceability: This method has been
standardized via ID-GC/MS (“Isotope
Dilution - Gas Chromatography/Mass
Spectrometry”). Every Elecsys reagent set
has a barcoded label containing specific
information for calibration of the particular
reagent lot. The predefined master curve is
adapted to the analyzer using the relevant
CalSet. | Same |
| Feature | Candidate Device
Elecsys Testosterone II (K211685) | Predicate Device
Elecsys Testosterone II (K093421) |
| Calibration
Interval | Calibration must be performed once per
reagent lot using fresh reagent (i.e. not
more than 24 hours since the reagent kit
was registered on the analyzer). Calibration
interval may be extended based on
acceptable verification of calibration by the
laboratory.
Renewed calibration is recommended as
follows:
• 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 defined limits. | Same |
| Controls | Controls for the various concentration
ranges should be run individually at least
once every 24 hours when the test is in use,
once per reagent kit, and following each
calibration.
The control intervals and limits should be
adapted to each laboratory's individual
requirements. Values obtained should fall
within the defined limits. Each laboratory
should establish corrective measures to be
taken if values fall outside the defined
limits. | Same |
| Reagent
Stability | unopened at 2-8 °C up to the stated
expiration date
after opening at 2-8 °C 12 weeks
on the analyzer 8 weeks | Same |
| Measuring
Range | 2.50-1500 ng/dL or 0.087-52.0 nmol/L
(defined by the Limit of Detection and the
maximum of the master curve). | Same |
Technical Characteristics Comparison Table between updated Table 1: Elecsys Testosterone II and current Elecsys Testosterone II
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7
| Feature | Candidate Device
Elecsys Testosterone II (K211685) | Predicate Device
Elecsys Testosterone II (K093421) |
|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Precision was evaluated on one cobas e
601 analyzer according to CLSI guideline
EP05-A3. The protocol consisted of testing
5 Aliquots of each control (PreciControl
Universal level 1 and PreciControl
Universal level 2) and human serum
samples (HS1-HS5) per run, 1 run per day
for 5 days with 3 lots. Repeatability and
intermediate precision (SD and CV values)
were calculated according to CLSI
EP05-A3. | Precision was evaluated on one 2010
analyzer according to CLSI guideline EP05-
A. The protocol consisted of testing 5
Aliquots of each control (PreciControl
Universal level 1 and PreciControl Universal
level 2) and human serum samples (HS1-
HS5) per run, 1 run per day for 5 days with 3
lots. Repeatability and intermediate precision
(SD and CV values) were calculated
according to CLSI EP05-A. |
| Precision | Precision was determined using Elecsys
reagents, human serum and controls in a
protocol (EP05-A3) of the CLSI (Clinical
and Laboratory Standards Institute): 2 runs
per day in duplicate each for 21 days (n =
84). | Precision was determined using Elecsys
reagents, pooled human sera and controls in a
separate study according to protocol (EP5-A)
of the CLSI (Clinical and Laboratory
Standards Institute): 2 runs per day in
duplicate each for 21 days (n = 84). |
| LoB | 1.50 ng/dL or 0.052 nmol/L | Limit of Blank: 1.2 ng/dL |
| LoD | 2.50 ng/dL or 0.087 nmol/L | Same |
| LoQ | 12.0 ng/dL or 0.416 nmol/L | Same |
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| Feature | Candidate Device
Elecsys Testosterone II (K211685) | | | Predicate Device
Elecsys Testosterone II (K093421) | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------|
| Cross Reactivity | Cross-Reactant | Concentration
(ng/mL) | Cross-
Reactivity
[%] | Cross-Reactant | Concentration
(ng/mL) | Cross-
Reactivity
[%] |
| | DHEA-S | 50000 | 0.003 | DHEA-S | 50000 |