ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)

K970126 · Bio-Rad Laboratories, Inc. · CHP · Feb 25, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970126
• Device Name: ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: CHP · Clinical Chemistry
• Decision Date: Feb 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1260
• Device Class: Class 1

Intended 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.

Device Story

ACCESS® Estradiol assay; paramagnetic particle chemiluminescent immunoassay; used with ACCESS® Immunoassay Analyzer. Input: human serum samples. Principle: simultaneous assay format using polyclonal rabbit anti-estradiol antibodies for capture and alkaline phosphatase conjugate; chemiluminescent reaction using dioxetane-based substrate. Output: quantitative estradiol concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in assessing estradiol levels. Benefits: provides quantitative measurement of estradiol for diagnostic evaluation.

Clinical Evidence

Bench testing only. Precision: within-run CV 2.7-11.6%, total imprecision 5.2-21.1%. Accuracy: spiking recovery 92-106%; dilution recovery mean 105% (SD 7%). Correlation: n=214 samples vs. Abbott IMx, r=0.958, y=-39+0.983x. Analytical sensitivity: 23 pg/ml (95% confidence). Specificity: Estrone sulfate not detectable at 3600 pg/ml; Estriol sulfate cross-reactivity 0.04% at 10,000,000 pg/ml.

Technological Characteristics

Paramagnetic particle chemiluminescent immunoassay. Reagents: polyclonal rabbit anti-estradiol antibodies, alkaline phosphatase conjugate, dioxetane-based chemiluminescent substrate. System: ACCESS® Immunoassay Analyzer. Simultaneous assay format. Multi-point liquid calibrators in human serum matrix.

Indications for Use

Indicated for the quantitative determination of Estradiol levels in human serum for clinical diagnostic purposes.

Regulatory Classification

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.

Predicate Devices

• Abbott IMx® Estradiol Kit

Submission Summary (Full Text)

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K970126
FEB 25 1997

# APPENDIX D - Summary of Safety and Effectiveness Information

## 1. General Information

January 13, 1997

Device Generic Name: Enzyme Immunoassay, Estradiol
Device Trade Name: ACCESS® Estradiol assay
Applicant's Name and Address: Sanofi Diagnostics Pasteur, Inc.
1000 Lake Hazeltine Drive
Chaska, MN 55318

Contact: Robert McCormack, Ph.D.
612-368-1384

## 2. Predicate Device

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 anti-estradiol 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 4-methylumbelliferyl 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 IMx® 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 format.

## 6. Summary of 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 S0 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.

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