ELECSYS PROGESTERONE ASSAY

K964841 · Boehringer Mannheim Corp. · JLS · Mar 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K964841
• Device Name: ELECSYS PROGESTERONE ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: JLS · Clinical Chemistry
• Decision Date: Mar 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1620
• Device Class: Class 1

Intended Use

Immunoassay for the in vitro quantitative determination of progesterone in human serum and plasma.

Device Story

Elecsys® Progesterone Assay is an electrochemiluminescence immunoassay for quantitative progesterone measurement in human serum/plasma. Assay uses competition principle: sample progesterone competes with ruthenium-labeled progesterone derivative for biotinylated polyclonal antibodies. Complex binds to streptavidin-coated microparticles. Microparticles are magnetically captured on electrode; voltage application induces chemiluminescence measured by photomultiplier. Total assay duration 18 minutes. Performed on Elecsys® 2010 instrument. Results calculated via instrument-specific calibration curve and master curve from reagent bar code. Used in clinical laboratory settings by trained personnel to aid in progesterone level assessment.

Clinical Evidence

Bench testing only. Performance evaluated via precision (n=60 per level), linearity (0.05-100 ng/mL), and method comparison (n=53) against Enzymun-Test® Progesterone. Method comparison showed Passing/Bablok slope 1.07, intercept -0.059, r=0.9914. Specificity testing performed against various steroids and Danazol with cross-reactivity <0.1%. Interference testing conducted for bilirubin, hemoglobin, lipemia, and biotin.

Technological Characteristics

Electrochemiluminescence immunoassay; utilizes ruthenium complex (Tris(2,2'-bipyridyl)ruthenium(II)) and streptavidin-coated microparticles. Requires Elecsys® 2010 instrument. Calibration via 2-point calibration and reagent bar code master curve. Linear range 0.05-100 ng/mL.

Indications for Use

Indicated for the in vitro quantitative determination of progesterone in human serum and plasma for clinical diagnostic purposes.

Regulatory Classification

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.

Predicate Devices

• Enzymun® Progesterone Assay (K931117)

Submission Summary (Full Text)

{0}

MAR 24 1997
K964841

BOEHRINGER MANNHEIM CORPORATION
510(k) Summary

Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

1. Submitter name, address, contact
Boehringer Mannheim Corporation
2400 Bisso Lane
P.O. Box 4117
Concord, CA 94524-4117
(510) 674 - 0690 extension 8415
FAX 510 687 - 1850

Contact Person: Mary Koning Patricia M. Klimley 25 2/24/97
Date Prepared: December 2, 1996

2. Device name
Proprietary name: Elecsys® Progesterone Assay
Common name: Electrochemiluminescence assay for the determination of progesterone.
Classification name: System, Test, Progesterone

3. Predicate device
We claim substantial equivalence to the Enzymun® Progesterone Assay (K931117).

Continued on next page

page 27

{1}

K964841

# 510(k) Summary, Continued

## 4. Device Description

Competition principle. Total duration of assay: 18 minutes (37 °C).

- 1st incubation (9 min.): 50 µL sample - in the presence of a progesterone-derivative labeled with a ruthenium complex (65 µL)** are incubated with Danazol to release progesterone.

- 2nd incubation (9 min.): After addition of biotinylated polyclonal progesterone-specific antibodies (50 µL) and streptavidin-coated microparticles (50 µL), progesterone from the sample competes with the labeled progesterone derivative for the antibody binding sites. At the same time the entire complex becomes bound to the solid phase via interaction of biotin and streptavidin. The proportion of labeled progesterone derivative bound to the solid phase is inversely proportional to the progesterone content of the sample.

- The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).

- Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.

**Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)²⁺)₃

## 5. Intended use

Immunoassay for the in vitro quantitative determination of progesterone in human serum and plasma.

Continued on next page

{2}

K964841

# 510(k) Summary, Continued

## 6. Comparison to predicate device

The Boehringer Mannheim Elecsys® Progesterone Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun-Test® Progesterone Assay (K931117).

The following table compares the Elecsys® Progesterone Assay with the predicate device, Enzymun-Test® Progesterone Assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6.

## Similarities:

- Intended Use: Immunoassay for the in vitro quantitative determination of progesterone
- Sample type: Serum and plasma
- Antibody: Same polyclonal progesterone antibody
- Solid phase binding principle: Streptavidin/Biotin

## Differences:

| Feature | Elecsys® Progesterone | Enzymun® Progesterone |
| --- | --- | --- |
| Assay Standardization | Enzymun® Progesterone | ID-GC/MS |
| Reaction test principle | Electrochemiluminescence | ELISA/1-step sandwich assay. |
| Instrument required | Elecsys® 2010 | ES 300 |
| Calibration Stability | A calibration is recommended every 7 days if kit is not consumed; 4 weeks with same reagent lot if reagent is consumed within 7 days. | Full calibration required every 2 weeks. One-point calibration required every run. |

Continued on next page

{3}

K964841

510(k) Summary, Continued

6. Comparison to predicate device, cont

Performance Characteristics:

| Feature | Elecsys® Progesterone | | | Enzymun® Progesterone | | |
| --- | --- | --- | --- | --- | --- | --- |
| Precision | Modified NCCLS (ng/mL): | | | Modified NCCLS (ng/mL): | | |
| Level | Low | Mid | High | Low | Mid | High |
| N | 60 | 60 | 60 | 60 | 60 | 60 |
| Within-Run: | 3.1 | 7.8 | 88.2 | 0.7 | 2.6 | 24.3 |
| Mean | 3.7 | 1.9 | 0.7 | 13.3 | 3.6 | 2.3 |
| %CV | 3.1 | 7.8 | 88.2 | 0.7 | 2.6 | 24.3 |
| Total: Mean | 6.8 | 3.1 | 0.8 | 22.4 | 5.9 | 2.6 |
| %CV | | | | | | |
| Lower Detection Limit | 0.05 ng/mL | | | 0.4 ng/mL | | |
| Linearity | 0.05-100 ng/mL (with a deviation from a linear line of ±10%) | | | 0.4-30 ng/mL (with a deviation from a linear line of ±10%) | | |
| Method Comparison | Vs Enzymun-Test® Progesterone
Least Squares
y = 1.04x + 0.165
r = 0.9914
SEE = 0.620
N = 53
Passing/Bablok
y = 1.07x - 0.059
r = 0.9914
SEE = 0.349
N = 53 | | | Vs Enzymun-Test® Progesterone
Least Squares
y = 1.01x + 0.27
r = 0.997
SEE = 0.717
N = 48 | | |
| Interfering substances | No interference at: | | | No interference at: | | |
| Bilirubin | 25 mg/dL | | | 64.5 mg/dL | | |
| Hemoglobin | 0.6 g/dL | | | 1 g/dL | | |
| Lipemia | 400 mg/dL | | | 250 mg/dL | | |
| Biotin | 30 ng/mL | | | 50 ng/mL | | |

Continued on next page

{4}

k964841

# 510(k) Summary, Continued

## 6. Comparison to predicate device, cont

### Performance Characteristics:

| Feature | Elecsys® Progesterone | | Enzymun® Progesterone | |
| --- | --- | --- | --- | --- |
| Specificity | Level tested (nMol/L) | % Cross-reactivity | Level tested | % Cross-reactivity |
| Testosterone | 4.7 | < 0.1 | --- | 0.03 |
| Danaznol | 2,000 | < 0.1 | --- | <0.001 |
| 5-Pregnen-3β-ol-20-one | 15 | < 0.1 | --- | 0.13 |
| 17α-Hydroxyprogesterone | 14 | < 0.1 | --- | 0.25 |
| 5β-Dihydroxyprogesterone | 20 | < 0.1 | --- | 3.0 |
| 4-Pregnene-20α-ol-3-one | 20 | < 0.1 | --- | 0.02 |
| 4-Androstene-3,17-dione | 13 | < 0.1 | --- | 0.02 |
| 5β-Pregnene-3α-ol-20-one | 20 | < 0.1 | --- | 1.7 |
| Corticosterone | 48 | < 0.1 | --- | 0.6 |
| 5α-Dihydrotestosterone | 0.93 | < 0.1 | --- | 1.4 |