(65 days)
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No
The description focuses on a standard immunoassay technology (CMIA) and provides performance metrics typical of such assays, with no mention of AI or ML.
No
This device is an immunoassay for the quantitative determination of testosterone, used in diagnosis and treatment monitoring, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of testosterone are used in the diagnosis and treatment of disorders..." which directly indicates its diagnostic purpose.
No
The device description clearly states it is a Chemiluminescent Microparticle Immunoassay (CMIA) and involves the use of reagents (calibrators and controls) and the Abbott ARCHITECT i System, which are hardware components.
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 involves testing biological samples in vitro (outside the body).
- Purpose: The measurements are used "in the diagnosis and treatment of disorders involving the male sex hormones." This directly aligns with the purpose of IVDs, which are used to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description confirms it's a "Chemiluminescent Microparticle Immunoassay (CMIA)" performed on the "Abbott ARCHITECT i System," which are laboratory-based methods for analyzing biological samples.
- Sample Type: It analyzes "human serum and plasma," which are biological specimens.
All these points clearly indicate that the Abbott ARCHITECT Testosterone device is designed to be used in vitro to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Abbott ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma on the Abbott ARCHITECT i System. 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 (comma separated list FDA assigned to the subject device)
CDZ
Device Description
ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Testosterone is calibrated with Abbott ARCHITECT Testosterone Calibrators. Abbott ARCHITECT Testosterone Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence has been demonstrated between the ARCHITECT Testosterone assay and the Chiron Diagnostics ACS:180® Testosterone assay. A least squares linear regression analysis between these two assays, using 607 specimens, yielded a correlation coefficient of 0.986, slope of 0.89 (95% Confidence Interval [CI] of 0.88 to 0.90), and y-axis intercept of -0.02 ng/mL (95% CI of -0.08 to 0.04).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Image /page/0/Picture/1 description: The image contains a series of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '9', '8', '3', '2', '1', and '2'. The handwriting style is cursive, with some numbers connected to each other.
510(k) Summary Abbott ARCHITECT™ Testosterone
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification [510(k)] for The Ionowing ----------------------------------------------------------------------------------------------------------------------------------------------------------------equivalent determination.
ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Testosterone is calibrated with Abbott ARCHITECT Testosterone Calibrators. Abbott ARCHITECT Testosterone Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.
Substantial equivalence has been demonstrated between the ARCHITECT Testosterone assay and the Chiron Diagnostics ACS:180® Testosterone assay. The intended use of the ARCHITECT Testosterone assay is for the quantitative determination of testosterone in human serum and plasma. The intended use of the Chiron Diagnostics ACS:180 Testosterone assay is for the quantitative determination of total testosterone (bound and unbound) in serum. Both assay are competitive immunoassays that use antibodies specific for testosterone and are performed on fully automated immunoassay systems. A least squares linear regression analysis between these two assays, using 607 specimens, yielded a correlation coefficient of 0.986, slope of 0.89 (95% Confidence Interval [CI] of 0.88 to 0.90), and y-axis intercept of -0.02 ng/mL (95% CI of -0.08 to 0.04).
In conclusion, these data demonstrate that the ARCHITECT Testosterone assay is as safe and effective as, and is substantially equivalent to, the Chiron Diagnostics ACS:180 Testosterone assay.
Prepared and Submitted September 11, 1998, by: Karen L. Gates, M.S. Sr. Regulatory Specialist ADD Regulatory Affairs (847) 938-0538 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537
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Image /page/1/Picture/1 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 a stylized symbol that resembles a human figure or a caduceus. The image is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Ms. Karen L. Gates, M.S. Senior Regulatory Specialist ADD Regulatory Affairs NOV 1 8 1998 Abbott Laboratories Diagnostics Division 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K983212 Trade Name: Abbott ARCHITECT™ Testosterone Product Code: CDZ Requlatory Class: I ris II JJX I
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JJE I Dated: September 11, 1998 September 14, 1998 Received:
Dear Ms. Gates:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number (if known): K983212 Device Name: Abbott ARCHITECT™ Testosterone
Indications For Use:
Abbott ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma on the Abbott ARCHITECT i System. 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.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K-983212
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)