(42 days)
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No
The summary describes a standard immunoassay system for quantitative determination of Estradiol levels. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on traditional analytical metrics like precision, accuracy, and correlation.
No
The device is an immunoassay for measuring Estradiol levels, which is a diagnostic function, not a therapeutic intervention.
Yes
The device is explicitly stated to be for the "quantitative determination of Estradiol levels in human serum," which is a measurement used for diagnosis or monitoring of health conditions.
No
The device description explicitly states that the system comprises both reagents and an analyzer, indicating a hardware component is essential for its function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of Estradiol levels in human serum". This indicates the device is used to test a sample taken from the human body (serum) in vitro (outside the body) to provide diagnostic information (estradiol levels).
- Device Description: The description mentions "ACCESS® Estradiol reagents" and the "ACCESS® Immunoassay Analyzer". These are components used to perform the test on the serum sample.
- Performance Studies: The performance studies describe testing characteristics like precision, accuracy, correlation, and analytical sensitivity, which are typical evaluations for IVD devices.
The core function of analyzing a human sample (serum) outside the body to provide a quantitative measurement for diagnostic purposes clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACCESS® Estradiol assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum using the ACCESS® Immunoassay System.
Product codes
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Device Description
The ACCESS® Estradiol reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of Estradiol levels in human serum.
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
human serum
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
Precision studies: Within run precision ranges from 11.6% CV (117 pg/ml) to 2.7% CV (3041 pg/ml). Total imprecision ranges from 21.1% CV (72 pg/ml) to 5.2% CV (1456 pg/ml).
Accuracy: Spiking recovery studies performed by spiking estradiol into ten serum samples results in recovery ranging from 92% to 106%. Dilution recovery studies performed by diluting 18 patient samples containing estradiol 1:2 with Estradiol Calibrator S0 results in a mean recovery of 105% with a standard deviation of 7%.
Correlation: A comparison of estradiol values from 214 samples run in both the ACCESS® Estradiol assay and the Abbott IMx® Estradiol Kit test gives the following statistical data: r= 0.958, y= -39 + 0.983x. Analytical Sensitivity: The lowest detectable level of estradiol distinguishable from zero (Estradiol Calibrator S0) with 95% confidence is 23 pg/ml.
Analytical Specificity: Estrone sulfate is not detectable when spiked into the S0 calibrator at 3600 pg/ml. Estriol sulfate gives an apparent cross reactivity of 0.04% when spiked into the So calibrator at 10,000,000 pg/ml.
Key Metrics
Precision (CV), Accuracy (Recovery%), Correlation (r, y intercept, slope), Analytical Sensitivity (lowest detectable level), Analytical Specificity (cross reactivity)
Predicate Device(s)
Abbott IMx® Estradiol Kit
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1260 Estradiol test system.
(a)
Identification. An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.(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.
0
FEB
25
1997
APPENDIX D - Summary of Safety and Effectiveness Information
-
- General Information
January 13, 1997
- General Information
Device Generic Name:
Enzyme Immunoassay, Estradiol
ACCESS® Estradiol assay
Device Trade Name:
Applicant's Name and Address:
Sanofi Diagnostics Pasteur, Inc. 1000 Lake Hazeltine Drive Chaska. MN 55318
Contact: Robert McCormack, Ph.D. 612-368-1384
Predicate Device 2.
Abbott IMx® Estradiol Kit Abbott Laboratories Diagnostics Division Abbott Park, IL 94547
3. Device Description
The ACCESS® Estradiol reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of Estradiol levels in human serum.
4. Indications for Use
The ACCESS® Estradiol assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum using the ACCESS® Immunoassay System.
5. Comparison of Technological Characteristics
The ACCESS® Estradiol assay and the Abbott IMx® Estradiol Kit are for the measurement of estradiol in human serum. Both tests utilize polyclonal rabbit antibodies for capture and an alkaline phosphatase conjugate. Both tests use multi-point liquid calibrators. The ACCESS® Estradiol assay uses a dioxetane based chemiluminescent substrate while the Abbott IMx® Estradiol Kit uses 4methylumbellifery| phosphate as the substrate. The ACCESS® Estradiol assay measures light production from a chemiluminescent reaction, while the Abbott IMx® Estradiol Kit measures a fluorescent product. The ACCESS® Estradiol assay uses calibrators prepared in a human serum matrix while the Abbott Max® " Estradiol Kit uses calibrators prepared in Tris buffer with protein stabilizers. The ACCESS® Estradiol assay uses a simultaneous assay format while the Abbott IMx® Estradiol Kit uses a sequential assay
6. Summary of Studies
format.
Precision studies: Within run precision ranges from 11.6% CV (117 pg/ml) to 2.7% CV (3041 pg/ml). Total imprecision ranges from 21.1% CV (72 pg/ml) to 5.2% CV (1456 pg/ml).
Accuracy: Spiking recovery studies performed by spiking estradiol into ten serum samples results in recovery ranging from 92% to 106%. Dilution recovery studies performed by diluting 18 patient samples containing estradiol 1:2 with Estradiol Calibrator S0 results in a mean recovery of 105% with a standard deviation of 7%.
Correlation: A comparison of estradiol values from 214 samples run in both the ACCESS® Estradiol assay and the Abbott IMx® Estradiol Kit test gives the following statistical data: r= 0.958, y= -39 + 0.983x. Analytical Sensitivity: The lowest detectable level of estradiol distinguishable from zero (Estradiol Calibrator S0) with 95% confidence is 23 pg/ml.
Analytical Specificity: Estrone sulfate is not detectable when spiked into the S0 calibrator at 3600 pg/ml. Estriol sulfate gives an apparent cross reactivity of 0.04% when spiked into the So calibrator at 10,000,000 pg/ml.
7. Conclusion
The ACCESS® Estradiol reagents when used with the ACCESS® Immunoassay Analyzer are substantially equivalent to another test for the measurement of estradiol levels now in commercial distribution.