(100 days)
No
The description details a standard immunoassay using chemiluminescent technology, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is for in vitro diagnostic use, meaning it's used to diagnose conditions by analyzing samples outside the body. It quantifies total testosterone, which helps in the diagnosis and treatment of disorders. It is not a device that directly treats or provides therapy to a patient.
Yes
The Intended Use / Indications for Use section explicitly states "For in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in serum" and that these measurements "are used in the diagnosis and treatment of disorders." This directly indicates its role as a diagnostic device.
No
The device description clearly outlines physical reagents and components (Primary Reagent ReadyPack, Lite Reagent, Solid Phase, Probe Wash, Ancillary Reagent ReadyPack, Releasing Agent, Calibrators) which are hardware/consumable elements, not software. The methodology is a competitive immunoassay, which is a laboratory technique involving physical components and chemical reactions.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP systems."
This statement clearly indicates that the device is intended to be used outside of the body (in vitro) to diagnose or aid in the diagnosis of various medical conditions by analyzing a biological sample (serum).
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP systems.
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 ADVIA Centaur TSTO assay consists of the following:
ADVIA Centaur TSTO Primary Reagent ReadyPack
- ADVIA Centaur TSTO Lite Reagent: acridinium ester-labeled testosterone in buffered saline with preservatives
- ADVIA Centaur TSTO Solid Phase: polyclonal rabbit antitestosterone antibody bound to monoclonal mouse antirabbit antibody covalently coupled to paramagnetic particles in buffered saline with sodium azide (0.1%) and preservatives
- Probe Wash: buffered saline with sodium azide (0.1%) and preservatives
ADVIA Centaur TSTO Ancillary Reagent ReadyPack
- ADVIA Centaur TSTO Releasing Agent: steroid releasing agent (~0.1 µg/mL) in buffered saline with sodium azide (0.1%) and preservatives
- Cal E Low and High Calibrators: (After reconstitution) low or high levels of cortisol, progesterone and testosterone in human plasma with sodium azide (0.1%) and preservatives
The methodology is competitive immunoassay using direct chemiluminescent technology.
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)
10.1 Precision
A 20-day precision study was performed according to CLSI EP5-A2. Samples included human specimen pools, three levels of controls and one in-house serum control. Each sample was assayed in 2 replicates per run, 2 runs per day for 20 days for a total of 80 replicates. Results from a representative lot are presented below.
| Sample | Mean (ng/mL) | Within-Run CV | Total CV |
|---|---|---|---|
| Patient Pool 1 | 57.8 | 8.7 | 13.3 |
| Patient Pool 2 | 211 | 4.0 | 7.9 |
| Patient Pool 3 | 336 | 4.5 | 7.4 |
| Patient Pool 4 | 574 | 5.5 | 7.1 |
| Patient Pool 5 | 1096 | 5.1 | 8.5 |
| Control Level 1 | 128 | 6.1 | 6.8 |
| Control Level 2 | 487 | 5.6 | 8.3 |
| Control Level 3 | 876 | 4.4 | 7.5 |
| Serum Control | 1167 | 5.7 | 9.1 |
10.2 Linearity
A linearity study was performed using the modified device according to CLSI EP06-A using 9 serially diluted samples spanning the assay range. The samples were assayed in triplicate and the mean of triplicate results was used for the analyses. As presented below, the mean recovery was between 90% and 110% and the bias from the linear fit estimate was
§ 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.
0
510(k) Summary of Safety and Effectiveness
FEB 2 1 2014 This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.
The assigned 510(k) Number is: K133491
1. Date Prepared
February 19, 2014
2. Applicant Information
| Contact: | Matthew Gee, M.Sc.
Senior Manager, Regulatory Affairs |
|----------|----------------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591-5097 |
| Phone: | 914-524-2099 |
| Fax: | 914-524-3579 |
| Email: | matthew.gee@siemens.com |
Regulatory Information 3.
Table 1. Regulatory Information for ADVIA Centaur TSTO Assay
| Trade Name | ADVIA Centaur® Testosterone (TSTO) |
|---|---|
| Model Numbers | 05476206 (5-pack); 07207660 (1-pack) |
| Common Name | Radioimmunoassay, testosterones and dihydrotestosterone |
| Classification Name | Testosterone test system |
| FDA Classification | Class I (Reserved) |
| Review Panel | Clinical Chemistry (75) |
| Product Code | CDZ |
| Regulation Number | 862.1680 |
4. Predicate Device Information
Predicate Device Name: ADVIA Centaur Testosterone (TSTO) assay
510(k) Number: K934562
5. Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP systems.
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.
1
Device Description 6.
The ADVIA Centaur TSTO assay consists of the following:
Table 2. Summary of Ingredients of the ADVIA Centaur TSTO Assay Components
| Component | Volume | Ingredients |
|---|---|---|
| ADVIA Centaur TSTO Primary Reagent ReadyPack | ||
| ADVIA Centaur TSTO | ||
| Lite Reagent | 2.5 mL/pack | acridinium ester-labeled testosterone in buffered |
| saline with preservatives | ||
| ADVIA Centaur TSTO | ||
| Solid Phase | 15.0 mL/pack | polyclonal rabbit antitestosterone antibody bound to |
| monoclonal mouse antirabbit antibody covalently | ||
| coupled to paramagnetic particles in buffered saline | ||
| with sodium azide (0.1%) and preservatives | ||
| Probe Wash | 10.0 mL/pack | buffered saline with sodium azide (0.1%) and |
| preservatives | ||
| ADVIA Centaur TSTO Ancillary Reagent ReadyPack | ||
| ADVIA Centaur TSTO | ||
| Releasing Agent | 5.0 mL/pack | steroid releasing agent (~0.1 µg/mL) in buffered saline |
| with sodium azide (0.1%) and preservatives | ||
| Cal E Low and High | ||
| Calibrators | 2.0 mL/vial | (After reconstitution) low or high levels of cortisol, |
| progesterone and testosterone in human plasma with | ||
| sodium azide (0.1%) and preservatives |
7. Purpose of the Submission
The purpose of this submission is to submit a modification to the ADVIA Centaur TSTO assay. The modification to the assay is due to the qualification of a new polyclonal rabbit anti-testosterone pool.
Comparison of Predicate Device and Modified Device 8.
The following table provides a comparison between the predicate ADVIA Centaur TSTO assay (with the current polyclonal antibody pool) and the modified ADVIA Centaur TSTO assay with a Solid Phase antibody derived from a newly-qualified polyclonal antibody pool.
| ltem | Predicate Device
(Current Polyclonal Ab Pool for
Solid Phase Antibody) | Modified Device
(New Polyclonal Ab Pool for
Solid Phase Antibody) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use in the
quantitative determination of total
testosterone (bound and unbound)
in serum using the ADVIA Centaur
and ADVIA Centaur XP Systems. | Same |
| Instrument Platforms | ADVIA Centaur
ADVIA Centaur XP | Same |
| Methodology | Competitive immunoassay using
direct chemiluminescent technology | Same |
Table 3. Comparison of Modified ADVIA Centaur TSTO Assay to Predicate
2
| ltem | Predicate Device
(Current Polyclonal Ab Pool for
Solid Phase Antibody) | Modified Device
(New Polyclonal Ab Pool for
Solid Phase Antibody) | |
|----------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------|--|
| Capture Antibody
(Solid Phase) | Polyclonal rabbit
anti-testosterone antibody | Same | |
| Tracer
(Lite Reagent) | Acridinium ester-labeled
testosterone | Same | |
| Specimen Type | Serum | Same | |
| Sample Volume | 15 ul | Same | |
| Measuring Range | 10-1500 ng/dL (0.35-52.1 nmol/L) | Same | |
| Calibration
2-point calibration
using Calibrator E | | Same | |
Table 3. Comparison of Modified ADVIA Centaur TSTO Assay to Predicate
Standard/Guidance Document References 9.
The following recognized standards from Clinical Laboratory Standards Institute (CLSI) were used as a basis of the study procedures described in this submission:
- Evaluation of Precision Performance of Quantitative Measurement Methods; . Approved Guideline - Second Edition (CLSI EP05-A2, 2004; Recognition Number 7-110)
- Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical l Approach; Approved Guideline (CLSI EP06-A, 2003; Recognition Number 7-193)
- . Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (CLSI EP07-A2, 2005; Recognition Number 7-127)
- . Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline -- Second Edition (CLSI EP17-A2, 2013; Recognition Number 7-233)
- . Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory: Approved Guideline - Third Edition (CLS) EP28-A3c - formerly C28-A3c, 2010; Recognition Number 7-224)
- 트 Medical devices - Application of risk management to medical devices (ANSI/AAMI/ISO 14971:2007/(R)2010; Recognition Number 5-70)
3
Performance Characteristics 10.
10.1 Precision
A 20-day precision study was performed according to CLSI EP5-A2. Samples included human specimen pools, three levels of controls and one in-house serum control. Each sample was assayed in 2 replicates per run, 2 runs per day for 20 days for a total of 80 replicates. Results from a representative lot are presented below.
| Sample | Mean (ng/mL) | Within-Run CV | Total CV |
|---|---|---|---|
| Patient Pool 1 | 57.8 | 8.7 | 13.3 |
| Patient Pool 2 | 211 | 4.0 | 7.9 |
| Patient Pool 3 | 336 | 4.5 | 7.4 |
| Patient Pool 4 | 574 | 5.5 | 7.1 |
| Patient Pool 5 | 1096 | 5.1 | 8.5 |
| Control Level 1 | 128 | 6.1 | 6.8 |
| Control Level 2 | 487 | 5.6 | 8.3 |
| Control Level 3 | 876 | 4.4 | 7.5 |
| Serum Control | 1167 | 5.7 | 9.1 |
10.2 Linearity
A linearity study was performed using the modified device according to CLSI EP06-A using 9 serially diluted samples spanning the assay range. The samples were assayed in triplicate and the mean of triplicate results was used for the analyses. As presented below, the mean recovery was between 90% and 110% and the bias from the linear fit estimate was