(21 days)
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No
The description details a standard immunoassay technology and automated instrument, with no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is intended for the quantitative determination of progesterone in serum or plasma as an aid in the diagnosis and treatment of disorders. It is a diagnostic tool, not a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device "is intended for use as an aid in the diagnosis and treatment of disorders of the overies and placenta." This directly indicates its role in diagnosis.
No
The device description clearly outlines hardware components like the automated VIDAS instrument, Solid Phase Receptacle (SPR), and Reagent Strips, which are integral to the assay's function. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantit determination of progesterone in serum or plasma" and is intended for use "as an aid in the diagnosis and treatment of disorders of the overies and placenta." This clearly indicates it's used to test samples taken from the human body to provide information for diagnosis and treatment.
- Device Description: The description details an "enzyme-linked fluorescent immunoassay (ELFA)" performed on an automated instrument using a "Solid Phase Receptacle (SPR)" and "Reagent Strips." This describes a laboratory test system designed to analyze biological samples.
- Performance Studies: The summary of performance studies includes analytical studies (cross-reactivity, interfering substances, precision) and clinical studies (correlation with a predicate device, sensitivity). These are typical studies performed to validate the performance of an in vitro diagnostic device.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to detect diseases, conditions, or infections. The VIDAS Progesterone assay fits this definition perfectly.
N/A
Intended Use / Indications for Use
The VIDAS Progesterone (PRG) assay is intended for use with a Vitek ImmunoDiagnostic Assay Systems (VIDAS) as an automated enzyme-linked fluorescent immunoassay (ELFA) for the quantit determination of progesterone in serum or plasma. The VIDAS Progesterone assay is intended for us an aid in the diagnosis and treatment of disorders of the overies and placenta.
Product codes
75 JLS
Device Description
The VIDAS Progesterone (PRG) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an automated VIDAS instrument. All assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as a solid phase for the assay as well as a pipetting device. At the time of manufacture, the SPR is coated with mouse anti-progesterone antibodies. Reagents for the assay are located in the sealed Reagent Strips. The sample is transferred into the well containing a progesterone derivative conjugated with alkaline phosphatase. Wash steps remove unbound conjugate. A fluorescent substrate, 4-methylumbellifory! phosphate, is cycled through the SPR and flouresences. The intensity of fluorescence is measured by the optical scanner in the instrument; it is inversely proportional to the progesterone concentration present in the sample.
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)
- Crossreactivity Specificity studies: The monoclonal antibody used in the VIDAS PRG assay is specific for progesterone. No cross-reactivity is seen with testosterone, corticosterone, 20a hydroxy-progesterone, 60 hydroxyprogesterone, 16a hydroxyprogesterone, Corticosterone, Estrone, Estriol and Estradiol. Cross-reactivity does exist with two metabolites of progesterone, specifically 5a and SB dilhydroxyprogesterone. Minimal cross-reactivity with 17a hydroxyprogesterone and decrycorticosterone.
- Interfering Substances: No interference in VIDAS PRG assay performance was seen with servan collected in dry glass tubes containing a separating gel, and tubes containing lithium heparin and EDTA. No interference with hemoglobin, lipids, or bilirubin.
- Precision/Reproducibility:
- Intra-assay precision: coefficients of variation ranging from 14.3% (for 0.46 ng/ml) to 3.8% (for 45.1 ng/ml).
- Inter-assay reproducibility (eight-week): coefficients of variation ranging from 24.3% (for 0.4 ng/ml) to 3.1% (for 45 norml).
- Inter-assay, inter-instrument reproducibility (five different serum samples in eight assays on different instruments): coefficients of variation do not exceed 5.4%.
- Correlation: Comparison of the VIDAS PRG assay with the DPC Coat-A-Count Progesterone assay yielded a line with the equation y = 1.0193x + -0.453 and a correlation coefficient of 0.985.
- Sensitivity: The limit of detection is determined to be 0.1 ng/ml of progesterone with a 95 % confidence interval.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Limit of detection: 0.1 ng/ml of progesterone (with a 95% confidence interval).
- Correlation coefficient: 0.985 (vs. DPC Coat-A-Count Progesterone assay).
- Coefficients of variation for precision/reproducibility as described above.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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) Summary Safety and Effectiveness Information for VIDAS Progesterone (PRG) Assay
K 965084
Submitter Terry McGovern Quality Assurance and Regulatory Affairs Manager bioMerieux Vitek, Inc. 1022 Hingham Street Rockland, MA 02370 tel. (617) 871-4442, extension 116 fax (617) 871-3470
JAN - 9 1997
Summary preparation date - 1/6/97
The VIDAS Progesterone (PRG) assay is intended for use with a Vitek ImmunoDiagnostic Assay Systems (VIDAS) as an automated enzyme-linked fluorescent immunoassay (ELFA) for the quantit determination of progesterone in serum or plasma. The VIDAS Progesterone assay is intended for us an aid in the diagnosis and treatment of disorders of the overies and placenta.
The Product Classification for the VIDAS Progesterone (PRG) assay is under 21CFR 862.1620 Progesterone test system and is a Class I, Triage Tier II test system. The product classification numb for the VIDAS Progesterone (PRG) is 75 JLS. The common or usual name is Enzyme-linked Fluorescent Immunoassay (ELFA) for the quantitative detection of progesterone.
The DPC Coat-A-Count Progesterone assay was used as the predicate device for the determination of substantial equivalence.
The VIDAS Progesterone (PRG) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an automated VIDAS instrument. All assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as a solid phase for the assay as well as a pipetting device. At the time of manufacture, the SPR is coated with mouse anti-progesterone antibodies. Reagents for the assay are located in the sealed Reagent Strips. The sample is transferred into the well containing a progesterone derivative conjugated with alkaline phosphatase. Wash steps remove unbound conjugate. A fluorescent substrate, 4-methylumbellifory! phosphate, is cycled through the SPR and flouresences. The intensity of fluorescence is measured by the optical scanner in the instrument; it is inversely proportional to the progesterone concentration present in the sample.
The technological characteristics of the bioMerieux Progesterone enzyme-linked | fluorescent immunoassay (ELFA) are different from the radiological method (RIA) of DPC Progesterone Coat-A-Count in that ELFA uses enzymes as labels instead of redioisotopes. Therefore enzyme activity not radioactivity is measured. Enzyme-linked fluorescent immunoassay is a well established method for assaying analytes present in human serum or plasma.
Non-clinical (analytical) study summary
- Crossreactivity Specificity studies demonstrate that the monoclonal antibody used in the VIDA 1. PRG assay is specific for progesterone. No cross-reactivity is seen with testosterone, corticosterone, 20a hydroxy-progesterone, 60 hydroxyprogesterone, 16a hydroxyprogesterone, Corticosterone, Estrone, Estriol and Estradiol. Cross-reactivity does exist with two metabolites of progesterone, specifically 5a and SB dilhydroxyprogesterone. The package insert cautions customers that individuals undergoing micronized progesterone therapy may exhibit elevated results when using the VIDAS PRG assay. 17a hydroxyprogesterone and decrycorticosterone demonstrated minimal crossreactivity. However, the normal concentrations found in a patient sera is far below that of
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progesterone. For example, in women, 17 a hydroxyprogesterone is 0.4ng/ml during the follicular phase and 1.8ng/ml in the luteal phase. In men the normal concentration is Ing/ml. For deoxycorticosterone the normal range is 40 - 160pg/ml. It is not likely that the VIDAS PRG assay will cause a falsely elevated progesterone result, due to the relative weak sera concentrations of 170 hydroxyprogesterone and deoxycorticosterone.
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- Interfering Substances No interference in VIDAS PRG assay performance was seen with servan collected in dry glass tubes containing a separating gel, and tubes containing lithium heparin and EDTA. No interference in the VIDAS PRG assay performance was seen with a range of concentrations of hemoglobin, lipids, or bilirubin.
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- Precision/Reproducibility Intra-assay precision stodies showed coefficients of variation ranging from 14.3% for 0.46 ng/ml to 3.8% for 45.1 ng/ml. Inter-assay reproducibility over a eight-week time period showed coefficients of variation ranging from 24.3% for 0.4 ng/ml to 3.1% for 45 norml. Inter-assay, inter-instrument reproducibility for five different serum samples in eight assays on different instruments vields coefficients of variation that do not exceed 5.4%.
Clinical study summary
1. Correlation
- Comparison of the VIDAS PRG assay with the DPC Coat-A-Count Progesterone assay yie 8. line with the equation y = 1.0193x + -0.453 and a correlation coefficient of 0.985.
- The calibrator in the kit ensures that the master curve stored by the VIDAS instrument is valid ﺷ for the shelf life of that kit. The body of data supports the use of a single calibrator for this purpose.
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- Sensitivity The limit of detection is determined to be 0.1 ng/ml of progesterone with: a 95 % confidence interval.
The conclusions drawn from the non-clinical and clinical tests demonstrate that the VIDAS PRG assey. if used as instructed in the package insert, is safe, effective and performs as well as or better than the legally marketed device identified in this submittal. The package insert should always be consulted along with the Operator's Manual to ensure that the assay is being performed properly. For additional information, references are listed in the package insert.
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