(136 days)
No
The summary describes a standard immunoassay technology (CMIA) and does not mention any AI or ML components in the device description, intended use, or performance studies. The calculation of the Free Testosterone Index (FTI) or Free Androgen Index (FAI) is a simple mathematical calculation based on the results of two assays, not an AI/ML algorithm.
No
This device is an in vitro diagnostic (IVD) assay designed to quantitatively determine testosterone levels, which is used for diagnosis and monitoring of disorders, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens)..." and lists several conditions like hypogonadism, delayed or precocious puberty, impotence, hirsutism, and virilization. This directly indicates its use in diagnosing health conditions.
No
The device is a chemiluminescent microparticle immunoassay (CMIA) which is a laboratory-based assay requiring physical reagents and an ARCHITECT i System, indicating it is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of testosterone in human serum and plasma." This is a measurement performed in vitro (outside the body) on biological samples.
- Diagnostic Purpose: The intended use also states that these measurements "are used in the diagnosis and treatment of disorders involving the male sex hormones..." This clearly indicates a diagnostic purpose.
- Device Description: The description details a "chemiluminescent microparticle immunoassay (CMIA)," which is a common laboratory technique for analyzing biological samples in vitro.
- Sample Type: The assay is performed on "human serum and plasma," which are biological specimens.
All these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARCHITECT 2nd Generation Testosterone assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma.
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 (comma separated list FDA assigned to the subject device)
CDZ
Device Description
The ARCHITECT 2nd Generation Testosterone assay is a delayed one-step immunoassay for the quantitative determination of testosterone in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex.
In the first step, sample, assay specific diluent, and anti-testosterone (sheep, monoclonal) coated paramagnetic microparticles are combined. Testosterone present in the sample binds to the anti-testosterone coated microparticles. After incubation, testosterone acridinium-labeled conjugate is added to the reaction mixture. After further incubation and washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An inverse relationship exists between the amount of testosterone in the sample and the RLUs detected by the ARCHITECT i System optics. The concentration of testosterone is interpolated from a calibration curve established with calibrators of known testosterone concentration.
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
Normal males 21-49 years of age, normal males > 50 years of age, premenopausal normal females 21-49 years of age, and postmenopausal normal females ≥ 50 years of age not on hormone replacement therapy.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
ARCHITECT 2nd Generation Testosterone FTI/FAI Performance Study:
Testing was performed on a minimum of 120 samples from individuals in the following categories: normal males 21-49 years of age, normal males > 50 years of age, premenopausal normal females 21-49 years of age, and postmenopausal normal females ≥ 50 years of age not on hormone replacement therapy.
The study included:
- Males (21-49 years of age): N=163
- Males (≥ 50 years of age): N=144
- Females (Premenopausal, 21-49 years of age): N=174
- Females (Postmenopausal, ≥ 50 years of age): N=175
Key Results: The study summarized SHBG and Testosterone levels, as well as % FTI or % FAI values for the different age and gender categories. The submission is for a labeling change to include these %FTI or %FAI Expected Values. The risk analysis performed indicated no change in the performance of the previously cleared assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Values reported for % FTI or % FAI:
- Males (21-49 years of age): Median (%) 46.6, 2.5th Percentile (%) 24.5, 97.5th Percentile (%) 113.3
- Males (≥ 50 years of age): Median (%) 40.7, 2.5th Percentile (%) 19.3, 97.5th Percentile (%) 118.4
- Females (Premenopausal, 21-49 years of age): Median (%) 2.0, 2.5th Percentile (%) 0.7, 97.5th Percentile (%) 8.7
- Females (Postmenopausal, ≥ 50 years of age): Median (%) 1.5, 2.5th Percentile (%) 0.5, 97.5th Percentile (%) 4.7
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ARCHITECT 2nd Generation Testosterone (cleared under K120009 on September 11, 2012)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2015
ABBOTT LABORATORIES REGINA KUMAR DIAGNOSTICS DIVISION 100 ABBOTT PARK RD ABBOTT PARK IL 60064
Re: K152155
Trade/Device Name: ARCHITECT 2nd Generation Testosterone Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone test system Regulatory Class: I, Reserved Product Code: CDZ Dated: November 13, 2015 Received: November 16, 2015
Dear Regina Kumar:
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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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.
Sincerely yours,
Katherine Serrano -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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Indications for Use
510(k) Number (if known)
Device Name ARCHITECT 2nd Generation Testosterone
Indications for Use (Describe)
The ARCHITECT 2nd Generation Testosterone assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma.
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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I. 510(k) Summary
The summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date: December 14, 2015
Applicant Name:
Regina Xavier Kumar, Regulatory Affairs Project Manager Abbott Laboratories Diagnostics Division 100 Abbott Park Road Abbott Park, IL 60064 Phone: 224-668-8093 Fax: 224-667-4836
Device Name:
Reagents
Classification Name: Radioimmunoassay, Testosterones and Dihydrotestosterones Trade Name: ARCHITECT 2nd Generation Testosterone Governing Regulation: 21 CFR 862.1680 Device Classification: Class I, Reserved Classification Panel: Clinical Chemistry Product Code: CDZ
Legally marketed device to which equivalency is claimed:
ARCHITECT 2nd Generation Testosterone (cleared under K120009 on September 11, 2012)
Intended Use/Indications for Use:
The ARCHITECT 2nd Generation Testosterone assay is a chemiluminescent microparticle
immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma.
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.
4
Description of Device:
The ARCHITECT 2nd Generation Testosterone assay is a delayed one-step immunoassay for the quantitative determination of testosterone in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex.
In the first step, sample, assay specific diluent, and anti-testosterone (sheep, monoclonal) coated paramagnetic microparticles are combined. Testosterone present in the sample binds to the anti-testosterone coated microparticles. After incubation, testosterone acridinium-labeled conjugate is added to the reaction mixture. After further incubation and washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An inverse relationship exists between the amount of testosterone in the sample and the RLUs detected by the ARCHITECT i System optics. The concentration of testosterone is interpolated from a calibration curve established with calibrators of known testosterone concentration.
Comparison of Technological Characteristics:
Both the submission device (ARCHITECT 2nd Generation Testosterone) and the predicate device (ARCHITECT 2nd Generation Testosterone [K120009]) have the same technological characteristics. Both devices use a chemiluminescent microparticle immunoassay (CMIA) technology for the quantitative determination of testosterone in human serum and plasma. There are no technological differences between the submission and predicate devices.
Comparison of Assay Performance:
The reagents, calibrators, and controls for the submission device and the predicate device are the same. The submission is to update the expected values section of the labeling to include the Free Testosterone Index (FTI) (also known as Free Androgen Index [FAI]). The risk analysis was performed and there is no change in the performance of the previously cleared assay. The performance data provided in K120009 still apply.
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Summary of Supporting Data:
The ARCHITECT 2nd Generation Testosterone expected values study was conducted in 2012 and is currently provided in the existing ARCHITECT 2nd Generation Testosterone reagent insert. A second study was conducted in 2014 to calculate FTI or FAI using ARCHITECT 2nd Generation Testosterone (List Number [LN] 2P13) and ARCHITECT SHBG (LN 8K26) assay results. The %FTI or %FAI calculated as [Total Testosterone] / [SHBG] provides an index of free testosterone status. The % FTI or % FAI correlates with the value of free testosterone.
ARCHITECT 2nd Generation Testosterone FTI/FAI Performance Study
Testing was performed on a minimum of 120 samples from individuals in the following categories: normal males 21-49 vears of age, normal males > 50 years of age, premenopausal normal females 21-49 years of age, and postmenopausal normal females ≥ 50 years of age not on hormone replacement therapy.
The following inclusion/exclusion criteria apply to the study:
Samples that were within the expected values of the ARCHITECT 2nd Generation Testosterone (LN 2P13) reagent insert and the ARCHITECT SHBG (LN 8K26) reagent insert were included in the study.
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| SHBG nmol/L | Testosterone nmol/L [ng/dL] | ||||||
|---|---|---|---|---|---|---|---|
| Category | N | Median | 2.5th | ||||
| Percentile | 97.5th | ||||||
| Percentile | Median | 2.5th | |||||
| Percentile | 97.5th | ||||||
| Percentile | |||||||
| Males | |||||||
| (21-49 years of age) | 163 | 31.1 | 16.2 | 68.5 | 15.33 | ||
| [442.07] | 8.76 | ||||||
| [252.73] | 27.85 | ||||||
| [803.24] | |||||||
| Males | |||||||
| (≥ 50 years of age) | 144 | 35.3 | 13.7 | 69.9 | 14.42 | ||
| [415.85] | 8.58 | ||||||
| [247.50] | 23.37 | ||||||
| [674.13] | |||||||
| Females | |||||||
| (Premenopausal, | |||||||
| 21-49 years of age) | 174 | 48.6 | 14.7 | 122.5 | 1.05 | ||
| [30.43] | 0.52 | ||||||
| [14.92] | 1.72 | ||||||
| [49.56] | |||||||
| Females | |||||||
| (Postmenopausal, | |||||||
| ≥ 50 years of age) | 175 | 49.9 | 16.7 | 124.4 | 0.76 | ||
| [21.83] | 0.46 | ||||||
| [13.34] | 1.18 | ||||||
| [33.90] |
The data from this study are summarized in the following tables.
The % FTI or % FAI values for the different groups are summarized in the following table.
| % FTI or % FAI | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Category | N | Median | |||||||
| (%) | 2.5th | ||||||||
| Percentile (%) | 97.5th | ||||||||
| Percentile (%) | |||||||||
| Males (21-49 years of age) | 163 | 46.6 | 24.5 | 113.3 | |||||
| Males (≥ 50 years of age) | 144 | 40.7 | 19.3 | 118.4 | |||||
| Females (Premenopausal, 21-49 years of age) | 174 | 2.0 | 0.7 | 8.7 | |||||
| Females (Postmenopausal, ≥ 50 years of age) | 175 | 1.5 | 0.5 | 4.7 |
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Conclusion:
The submission is for a labeling change for the %FTI or %FAI Expected Values only. The risk analysis was performed and there is no change in the performance of the previously cleared assay. The performance data provided in K120009 still apply.
The ARCHITECT 2nd Generation Testosterone assay (LN 2P13) is substantially equivalent to the predicate device because the proposed labeling change does not alter the intended use, indications for use, or the fundamental scientific technology of the predicate device. Furthermore, the residual risk is low because the identified and verified control measures eliminate or reduce the potential effects of failure.
Both ARCHITECT 2nd Generation Testosterone and ARCHITECT SHBG (K152185) labeling will be updated to include the %FTI or %FAI expected values generated using these assays.