ELECSYS HCG ASSAY

K961487 · Boehringer Mannheim Corp. · DHA · Jun 12, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961487
• Device Name: ELECSYS HCG ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: DHA · Clinical Chemistry
• Decision Date: Jun 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

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

Device Story

Elecsys® HCG Assay is an immunoassay for quantitative HCG determination in human serum and plasma. Device uses electrochemiluminescence principle; sample incubated with biotinylated HCG-specific antibody and ruthenium-labeled anti-HCG antibody. Streptavidin-coated microparticles bind complex; mixture aspirated into measuring cell; microparticles magnetically captured on electrode. Voltage application induces chemiluminescent emission measured by photomultiplier. Results calculated via instrument-specific calibration curve and master curve from reagent bar code. Used in clinical laboratory settings on Elecsys® 2010 instrument. Provides quantitative HCG levels to assist in clinical decision-making.

Clinical Evidence

Bench testing only. Performance compared to Enzymun® HCG Assay using 64 samples. Precision evaluated via modified NCCLS protocol (N=60 per level); within-run %CV 2.7-4.5%, total %CV 3.9-5.8%. Lower detection limit 0.5 mIU/mL. Linearity 0.5-1,000 mIU/mL. Method comparison (Least Squares) yielded y = 1.35x - 9.21 (r=0.989). Interference testing performed for bilirubin, hemoglobin, lipemia, and biotin. Specificity tested against LH, FSH, and TSH.

Technological Characteristics

Electrochemiluminescence immunoassay; utilizes biotinylated antibodies and streptavidin-coated microparticles. Requires Elecsys® 2010 instrument. Calibration via 2-point method and reagent bar code master curve. Assay duration 18 minutes at 37°C. Photomultiplier detection system.

Indications for Use

Indicated for the in vitro quantitative determination of human chorionic gonadotropin (HCG) in human serum and plasma.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Predicate Devices

• Enzymun® HCG Assay (K896901)

Submission Summary (Full Text)

{0}

K961487
Diagnostics

JUN 12 1996

# 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

Contact Person: Mary Koning

Date Prepared: April 9, 1996

2. Device name

Proprietary name: Elecsys® HCG Assay

Common name: Electrochemiluminescence assay for the determination of human chorionic gonadotropin (HCG).

Classification name: System, Test, Human Chorionic Gonadotropin

3. Predicate device

We claim substantial equivalence to the Enzymun® HCG Assay (K896901).

4. Device Description

The Elecsys® test principle is based on competition principle. Total duration of assay: 18 minutes (37° C).

- 1st incubation (9 minutes): Sample (15 μL), a biotinylated HCG specific antibody (75 μL), and a specific anti-HCG antibody labeled with a ruthenium complex (75 μL).

- 2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (35 μL), the still-free binding sites of the labeled antibody become occupied, with formation of an antibody-hapten complex. The entire complex is bound to the solid phase via interaction of biotin and streptavidin.

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Diagnostics

# 510(k) Summary, Continued

## 4. Device Description

- 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.

## 5. Intended use

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

## 6. Comparison to predicate device

The Boehringer Mannheim Elecsys® HCG 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® HCG Assay (K896901).

The following table compares the Elecsys® HCG Assay with the predicate device, Enzymun® HCG 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 human chorionic gonadotropin (HCG)
- Sample type: Serum and plasma
- Antibody: Polyclonal Sheep anti-HCG antibodies
- Solid phase binding principle: Streptavidin/Biotin
- Assay standardization: World Health Organization Standard (WHO) 75/537 (1st IRP).

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Diagnostics

# 510(k) Summary, Continued

## 6. Comparison to predicate device cont.

### Differences:

| Feature | Elecsys® HCG | Enzymun® HCG |
| --- | --- | --- |
| Reaction test principle | Electrochemiluminescence | ELISA/1-step sandwich assay using streptavidin technology |
| Instrument required | Elecsys® 2010 | ES 300 |
| Calibration Stability | A calibration is recommended every 7 days if kits is not consumed; 4 weeks with same reagent lot if reagent is consumed within 7 days. | Calibration required every run |

### Performance Characteristics:

| Feature | Elecsys® HCG | | | Enzymun® HCG | | |
| --- | --- | --- | --- | --- | --- | --- |
| Precision | Modified NCCLS (mIU/mL): | | | Modified NCCLS (μg/dL): | | |
| Level | Serum | Control 1 | Control 2 | Low | Mid | High |
| N | 60 | 60 | 60 | 58 | 58 | 53 |
| Within-Run | 24.80 | 35.39 | 854.30 | 19.9 | 181.5 | 593.8 |
| %CV | 4.5 | 3.3 | 2.7 | 4.6 | 2.9 | 3.1 |
| Total | 24.80 | 35.39 | 854.30 | 19.9 | 181.5 | 593.8 |
| %CV | 5.8 | 3.9 | 4.5 | 5.7 | 4.6 | 4.1 |
| Lower Detection Limit | 0.5 mIU/mL | | | 1.5 mIU/mL | | |

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Diagnostics

# 510(k) Summary, Continued

## 6. Comparison to predicate device, (cont.)

### Performance Characteristics:

| Feature | Elecsys® HCG | | Enzymun® HCG | |
| --- | --- | --- | --- | --- |
| Linearity | 0.5 - 1,000 mIU/mL (with a deviation from a linear line of ±10%) | | 1.5 - 600 mIU/mL (with a deviation from a linear line of ±10%) | |
| Method Comparison | Vs Enzymun-Test® HCG
Least Squares
y = 1.35x - 9.21
r = 0.989
SEE = 17.50
N = 64

Passing/Bablok
y = 1.29x - 4.05
r = 0.989
SEE = 17.50
N = 64 | | Vs Enzymun-Test® HCG
Least Squares
y = 1.047x - 4.92
r = 0.996
SEE = 13.056
N = 49 | |
| Interfering substances | No interference at: | | No interference at: | |
| Bilirubin | 25 mg/dL | | 51.7 mg/dL | |
| Hemoglobin | 1 g/dL | | 1 g/dL | |
| Lipemia | 1500 mg/dL | | 1250 mg/dL | |
| Biotin | 30 ng/mL | | 200 ng/mL | |
| Specificity | Level tested (mIU/mL) | % Cross-reactivity | Level tested (mIU/mL) | % Cross-reactivity |
| LH | 1000 | 0.07 | 400 | 0.15 |
| FSH | 1000 | 0.09 | 400 | 0.28 |
| TSH | 2500 | 0.000 | 2000 | 5.0 |

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