(126 days)
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No
The summary describes a standard immunoassay for progesterone and does not mention any AI or ML components.
No
The device is described as a microparticle enzyme immunoassay for the quantitative determination of progesterone, which is a diagnostic tool, not one that treats or cures a disease.
Yes
The device is described as an immunoassay for the "quantitative determination of progesterone in human serum and plasma," which directly relates to diagnosing or monitoring physiological states. Furthermore, a predicate device is listed, and its name "Diagnostics Products Corporation Coat-A-Count® Progesterone assay" contains the word "Diagnostics," reinforcing its use in diagnosis.
No
The device description explicitly states it is a "microparticle enzyme immunoassay" and is used with the "Abbott AxSYM System," indicating it is a laboratory assay kit and associated hardware, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of progesterone in human serum and plasma". This indicates that the device is used to test samples taken from the human body (in vitro) to provide diagnostic information.
- Device Description: The description confirms it's a "microparticle enzyme immunoassay", which is a common type of in vitro diagnostic test.
- Sample Type: It specifies the use of "human serum and plasma", which are biological samples.
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
for the quantitative determination of progesterone in human serum and plasma (heparin or EDTA).
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
AxSYM Progesterone is a microparticle enzyme immunoassay for the quantitative determination of progesterone in human serum and plasma (heparin or EDTA). AxSYM Progesterone is calibrated with Abbott calibrators and Abbott controls are used for verification of the calibration and to monitor the performance of the Abbott AxSYM 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)
A correlation analysis between these two assays, using 209 specimens, yielded a correlation coefficient of 0.96, slope of 0.86, standard error of Y-estimate of 2.29 and Y-axis intercept of 0.77 ng/mL. Both assays have a dynamic range of 0 - 40 ng/mL progesterone.
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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§ 862.1620 Progesterone test system.
(a)
Identification. A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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510(K) SUMMAR Y ABBOTT AxSYM PROGESTERONE
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A SUBSTANTIALLY EQUIVALENT DETERMINATION
The following information as presented in the Premarket Notification for AxSYM® Progesterone constitutes data supporting a substantially equivalent determination.
AxSYM Progesterone is a microparticle enzyme immunoassay for the quantitative determination of progesterone in human serum and plasma (heparin or EDTA). AxSYM Progesterone is calibrated with Abbott calibrators and Abbott controls are used for verification of the calibration and to monitor the performance of the Abbott AxSYM System.
Substantial equivalence has been demonstrated between the Abbott AxSYM Progesterone assay and the Diagnostics Products Corporation Coat-A-Count® Progesterone assay. The intended use of both assays is for the quantitative determination of progesterone in human serum or plasma . A correlation analysis between these two assays, using 209 specimens, yielded a correlation coefficient of 0.96, slope of 0.86, standard error of Y-estimate of 2.29 and Y-axis intercept of 0.77 ng/mL. Both assays have a dynamic range of 0 - 40 ng/mL progesterone.
In conclusion, these data demonstrate that the AxSYM Progesterone assay is as safe and effective and is substantially equivalent to the Diagnostics Products Corporation Coat-A-Count Progesterone assay.
Prepared and Submitted October 31, 1995, by:
Abbott Laboratories Joy C. Sonsalla Senior Regulatory Specialist ADD Regulatory Affairs Abbott Park, IL 60064
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