(100 days)
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.
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.
The Siemens Healthcare Diagnostics Inc. ADVIA Centaur TSTO assay is a device for the quantitative determination of total testosterone in serum. The submission (K133491) is for a modification to the assay due to the qualification of a new polyclonal rabbit anti-testosterone pool. This is a Class I (Reserved) device, product code CDZ, and is regulated under 21 CFR 862.1680.
Here's an analysis of the acceptance criteria and study in relation to the modified device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes specific performance characteristics rather than explicit "acceptance criteria" with numerical thresholds for each test. However, we can infer the acceptance for some based on the reported results and the comparison to an existing predicate device. The primary acceptance for this submission is demonstrating "substantial equivalence" to the predicate device.
| Performance Characteristic | Implicit Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|---|
| Precision | CVs within acceptable ranges for clinical assays. | Patient Pool CVs: 7.1% - 13.3% Control Level CVs: 6.8% - 8.3% Serum Control CV: 9.1% | Considered acceptable for diagnostic assays. |
| Linearity | Mean recovery between 90-110%; Bias from linear fit estimate <10%. | Mean recovery: 90.2% - 105.7% Bias: -8.9% - 6.6% (Observed = 0.99(Expected) + 0.06 ng/dL, r = 0.999) | Met inferred criteria. |
| Method Comparison | High correlation and minimal bias compared to the predicate device. | Modified Device = 0.970(Unmodified Device) + 7.5 ng/dL (r = 0.994) | Indicates strong agreement with the predicate device. |
| Reference Intervals | Existing reference intervals for the predicate device are applicable to the modified device. | 19/20 male samples within range; 18/20 female samples within range. | Demonstrated applicability of existing reference intervals. |
| Detection Limit (LoD) | LoD within clinically relevant range. | 10 ng/dL | A reported value, demonstrating the assay's lower detection capabilities. |
| Endogenous Interference | Interference effect (percentage) considered clinically insignificant. | Hemoglobin: 3.14% Triglycerides: -0.92% Conjugated Bilirubin: 2.24% Unconjugated Bilirubin: 3.32% | Considered low interference. |
| Cross-Reactivity | Low cross-reactivity with structurally similar compounds. | Most cross-reactants showed very low (<0.1%) cross-reactivity. 5a-dihydrotestosterone had 5.21% (Multi-diluent 3) and 4.85% (Test Sample) cross-reactivity. | 5a-dihydrotestosterone shows some cross-reactivity, but this is a known issue with testosterone assays due to structural similarity. The other compounds were low. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Precision:
- Sample Size: Human specimen pools, three levels of controls, and one in-house serum control. Each sample assayed in 2 replicates per run, 2 runs per day for 20 days (total of 80 replicates per sample type).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Implicitly, this is a prospective study conducted during device development/modification.
- Linearity:
- Sample Size: 9 serially diluted samples. Each sample assayed in triplicate.
- Data Provenance: Not explicitly stated. Implicitly, prospective.
- Method Comparison:
- Sample Size: 120 serum samples.
- Data Provenance: Not explicitly stated. Implicitly, prospective.
- Reference Interval Verification:
- Sample Size: 20 female and 20 male apparently healthy donors (serum samples).
- Data Provenance: Not explicitly stated. Implicitly, prospective.
- Detection Limit:
- Sample Size: Not specified beyond "series of results" for LoB and "smallest amount" for LoD.
- Data Provenance: Not explicitly stated. Implicitly, prospective.
- Endogenous Interference:
- Sample Size: Two sample pools (one low, one high testosterone), spiked with potential interferents. Samples tested in replicates of three (3).
- Data Provenance: Not explicitly stated. Implicitly, prospective.
- Cross-Reactivity:
- Sample Size: One low testosterone sample and one Multi-Diluent 3 sample (~0 ng/dL), spiked with potential cross-reactants. Tested in replicates of 6 per sample.
- Data Provenance: Not explicitly stated. Implicitly, prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Ground truth in this context refers to the true concentration of testosterone or the presence/absence of interferents/cross-reactants. For in vitro diagnostic assays like this, the "ground truth" is typically established by:
- Reference Methods: Often a gold-standard method (e.g., mass spectrometry) or a well-validated reference assay. While not explicitly mentioned as a separate ground truth determination step for the test samples themselves (rather, the predicate device is the comparison), it's assumed that the predicate device and the methods for spiking samples are based on established and accurate measurements.
- Known Concentrations: For linearity, interference, and cross-reactivity studies, the "ground truth" is the known concentration of the analyte or interferent/cross-reactant that was spiked into the samples.
The document does not mention the use of human experts (e.g., radiologists) for adjudication or establishing ground truth in the way it would be for imaging diagnostics. The ground truth here is analytical, based on chemical and laboratory standards.
4. Adjudication Method for the Test Set:
Not applicable. This is an in vitro diagnostic device reporting quantitative measurements, not a diagnostic imaging device requiring expert consensus for interpretation. The performance is assessed statistically against predefined analytical standards or comparative methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with vs. without AI Assistance:
Not applicable. This is an in vitro diagnostic assay for measuring testosterone levels, not an AI-assisted diagnostic imaging device or a device involving human interpretation of complex data for a "case." Therefore, an MRMC study and AI assistance effect size are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are standalone device performance studies. The ADVIA Centaur TSTO assay is an automated diagnostic instrument. The performance characteristics (precision, linearity, method comparison, etc.) are evaluated based solely on the output of the instrument (the "algorithm" or assay chemistry) itself, without human intervention in the result determination process beyond running the assay and interpreting the quantitative data.
7. The Type of Ground Truth Used:
The ground truth used in these studies is primarily:
- Known concentrations: For linearity, interference, and cross-reactivity studies, the ground truth is established by spiking samples with known quantities of the analyte or interfering substances.
- Predicate Device Measurements: For method comparison, the results from the predicate device (unmodified ADVIA Centaur TSTO assay) serve as the comparative "ground truth" to demonstrate substantial equivalence.
- Defined Reference Ranges: For reference interval verification, the "ground truth" is the established reference intervals for males and females.
8. The Sample Size for the Training Set:
This document does not specify a separate "training set" in the context of machine learning or AI. For in vitro diagnostic assays, the assay parameters are developed and optimized through extensive R&D, often using a multitude of samples, but these are not typically referred to as a "training set" in the AI sense. The submission describes the validation of a modified device. The original development of the predicate device would have involved internal "training" or optimization, but those details are not provided here.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" described in the AI/machine learning sense, this question is not directly applicable. For the development of the assay (which is analogous to training in a broader sense), the ground truth would have been established through methodologies such as:
- Reference methods: Using gold standard analytical techniques to accurately quantify testosterone.
- Highly purified standards: Using precisely weighed and quantified testosterone standards to calibrate the assay and ensure accurate measurement.
- Gravimetric and volumetric preparations: For preparing calibrators, controls, and spiked samples, relying on accurate laboratory techniques to establish known concentrations.
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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 AvenueTarrytown, 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.
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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 TSTOLite Reagent | 2.5 mL/pack | acridinium ester-labeled testosterone in bufferedsaline with preservatives |
| ADVIA Centaur TSTOSolid Phase | 15.0 mL/pack | polyclonal rabbit antitestosterone antibody bound tomonoclonal mouse antirabbit antibody covalentlycoupled to paramagnetic particles in buffered salinewith sodium azide (0.1%) and preservatives |
| Probe Wash | 10.0 mL/pack | buffered saline with sodium azide (0.1%) andpreservatives |
| ADVIA Centaur TSTO Ancillary Reagent ReadyPack | ||
| ADVIA Centaur TSTOReleasing Agent | 5.0 mL/pack | steroid releasing agent (~0.1 µg/mL) in buffered salinewith sodium azide (0.1%) and preservatives |
| Cal E Low and HighCalibrators | 2.0 mL/vial | (After reconstitution) low or high levels of cortisol,progesterone and testosterone in human plasma withsodium 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 forSolid Phase Antibody) | Modified Device(New Polyclonal Ab Pool forSolid Phase Antibody) |
|---|---|---|
| Intended Use | For in vitro diagnostic use in thequantitative determination of totaltestosterone (bound and unbound)in serum using the ADVIA Centaurand ADVIA Centaur XP Systems. | Same |
| Instrument Platforms | ADVIA CentaurADVIA Centaur XP | Same |
| Methodology | Competitive immunoassay usingdirect chemiluminescent technology | Same |
Table 3. Comparison of Modified ADVIA Centaur TSTO Assay to Predicate
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| ltem | Predicate Device(Current Polyclonal Ab Pool forSolid Phase Antibody) | Modified Device(New Polyclonal Ab Pool forSolid Phase Antibody) | |
|---|---|---|---|
| Capture Antibody(Solid Phase) | Polyclonal rabbitanti-testosterone antibody | Same | |
| Tracer(Lite Reagent) | Acridinium ester-labeledtestosterone | Same | |
| Specimen Type | Serum | Same | |
| Sample Volume | 15 ul | Same | |
| Measuring Range | 10-1500 ng/dL (0.35-52.1 nmol/L) | Same | |
| Calibration2-point calibrationusing 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)
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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 <10%.
| Sample | Expected(ng/dL) | Observed(ng/dL) | Recovery | WeightedLinear FitEstimate | Bias |
|---|---|---|---|---|---|
| A | 1529.7 | 1529.7 | 100.0% | 1514.4 | 1.0% |
| B | 1141.8 | 1148.0 | 99.5% | 1136.6 | 0.5% |
| C | 781.2 | 766.4 | 101.9% | 758.8 | 3.0% |
| D | 347.2 | 384.8 | 90.2% | 381.0 | -8.9% |
| E | 178.6 | 194.0 | 92.1% | 192.1 | -7.0% |
| F | 98.9 | 98.6 | 100.3% | 97.7 | 1.2% |
| G | 53.8 | 50.9 | 105.7% | 50.4 | 6.6% |
| H | 27.5 | 27.0 | 101.8% | 26.8 | 2.6% |
| I | 3.2 | 3.2 | 100.0% | 3.2 | -0.9% |
The weighted linear regression equation is presented below.
Observed = 0.99(Expected) + 0.06 ng/dL (r = 0.999)
10.3 Method Comparison
A method comparison study was performed by comparing the modified device to the currently-marketed predicate device (unmodified ADVIA Centaur TSTO assay) with 120 serum samples distributed over the assay range. The analysis was performed using Deming (Orthagonal) regression. The regression equation from the analysis is presented below.
Modified Device = 0.970(Unmodified Device) + 7.5 ng/dL (r = 0.994)
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10.4 Matrix Comparison
Not applicable. Serum is the only claimed sample type for the assay.
10.5 Reference Intervals
Reference intervals ADVIA Centaur TSTO assay were established using the predicate device. The Package Insert claims the following expected values for adult males and females:
Males: 241 to 827 ng/dL
Females: 14 to 76 ng/dL
A reference interval verification study was performed with the modified device according to CLSI EP28-A3c. Results of serum samples from 20 female and 20 male apparently healthy donors tested with the modified device were compared to the published claims in the Package Insert of the currently-marketed predicate device (unmodified ADVIA Centaur TSTO assay). For the male reference interval verification study, 19 specimens were within the range of 241 to 827 ng/dL (1 specimen was below range). For the female reference interval verification study, 18 specimens were within the range of 14 to 76 ng/dL (2 specimens were above range). These results demonstrate that the existing reference intervals for the unmodified predicate device are also applicable to the modified device.
10.6 Detection Limit
The estimations of the Limit of Blank (LoB) and Limit of Detection were performed according to CLSI guideline EP17-A2. Limit of Blank (LoB) is the highest value expected in a series of results on a sample that contains no analyte. The LoB for the modified ADVIA Chemistry TSTO assay is 3 ng/dL. The Limit of Detection (LoD) is the smallest amount that the assay can reliably detect to determine presence or absence of an analyte. The LoD for the modified ADVIA Chemistry TSTO assay is 10 ng/dL.
10.7 Endogenous Interference
Endogenous interference studies were performed according to CLSI EP07-A2. Two sample pools were tested. One sample pool had approximately 90 to 110 ng/dL testosterone. The second sample pool had approximately 360 to 440 ng/dL testosterone. These sample pools were spiked with potential interferents. Control samples were prepared by spiking sample pools with the appropriate diluent at the same volume as the interfering substance stock. Samples were tested in replicates of three (3) using the modified device. Results are presented below.
| Endogenous Substance | Dose WithoutEndogenousSubstance(ng/dL) | Dose WithEndogenousSubstance(ng/dL) | % Interference |
|---|---|---|---|
| Hemoglobin (500 mg/dL) | 223 | 230 | 3.14 |
| Triglycerides (1000 mg/dL) | 218 | 216 | -0.92 |
| Conjugated Bilirubin (20 mg/dL) | 223 | 228 | 2.24 |
| Unconjugated Bilirubin (20 mg/dL) | 211 | 218 | 3.32 |
10.8 Cross-Reactivity
Potential cross-reactants were spiked into one low sample (~ 90-110 ng/dL testosterone) and into one sample consisting only of Multi-Diluent 3 (~ 0 ng/dL). Testing was performed using the modified device in replicates of 6 per sample. Results are presented below.
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| Cross-Reactant | CrossReactant Conc.ng/dL | Multi-diluent 3 | Test Sample | ||
|---|---|---|---|---|---|
| (ng/dL) | % CrossReactivity (%) | (ng/dL) | % CrossReactivity (%) | ||
| 5a-dihydrotestoterone | 100000 | 522.381.13 | 5.21 | 579.6294.97 | 4.85 |
| Androstenedione | 100000 | 1.263.29 | -0.02 | 108.39102.54 | 0.06 |
| Methyltestosterone | 100000 | 13.900.00 | 0.14 | 129.5890.95 | 0.39 |
| Estradiol-17β | 100000 | 0.210.29 | 0.00 | 89.6291.34 | 0.00 |
| Androsterone | 1000000 | 9.411.64 | 0.01 | 106.7298.36 | 0.01 |
| Cortisol | 1000000 | 18.7213.46 | 0.01 | 102.4897.08 | 0.01 |
| Corticosterone | 1000000 | 4.251.42 | 0.00 | 103.54101.10 | 0.00 |
| Cyproterone | 100000 | 16.1014.16 | 0.00 | 98.57103.26 | 0.00 |
| Danazol | 1000000 | 43.070.46 | 0.04 | 160.6392.76 | 0.07 |
| DHEA-sulfate | 1000000 | 0.000.00 | 0.00 | 98.69105.85 | -0.01 |
| 11-deoxycortisol | 1000000 | 1.120.70 | 0.00 | 103.1393.33 | 0.01 |
| Dexamethasone | 1000000 | 0.600.00 | 0.00 | 94.1797.98 | 0.00 |
| Estrone | 100000 | 2.160.00 | 0.02 | 89.4796.58 | -0.01 |
| Oxymetholone | 100000 | 15.4516.15 | -0.01 | 104.59103.28 | 0.01 |
| Progesterone | 1000000 | 92.742.23 | 0.09 | 188.82101.45 | 0.09 |
510(k) Summary of Safety and Effectiveness
10.9 Stability
The onboard stability of the ADVIA Centaur TSTO reagents is 14 days with a calibration interval of 7 days. The reagents are stable until the date printed on the box label when stored at 2-8°C.
Clinical Studies 10.10
Not applicable.
Clinical Cut-off 10.11
Not applicable.
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11. Conclusions
Based on the results of comparative testing, the modified ADVIA Centaur TSTO assay is substantially equivalent in principle and performance to the currently-marketed predicate device, the ADVIA Centaur TSTO assay, cleared under 510(k) K934562.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SIEMENS HEALTHCARE DIAGNOSTICS INC. MATTHEW GEE SENIOR MANAGER, REGULATORY AFFAIRS 511 BENEDICT AVENUE TARRYTOWN NY 10591-5097
February 21, 2014
Re: K133491
Trade/Device Name: ADVIA Centaur Testosterone (TSTO) Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone test system Regulatory Class: I, reserved Product Code: CDZ Dated: December 18, 2013 Received: January 7, 2014
Dear Mr. Gec:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2—Mr. Gee
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ruth A. Chesler -S
for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133491
Device Name ADVIA Centaur Testosterone (TSTO)
Indications for Use (Describe)
For in vitro diagnostic use in the quantiation 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 inomones (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.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
§ 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.