ELECSYS LH ASSAY

K964694 · Boehringer Mannheim Corp. · CEP · Jan 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K964694
• Device Name: ELECSYS LH ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: CEP · Clinical Chemistry
• Decision Date: Jan 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1485
• Device Class: Class 1

Intended Use

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

Device Story

Elecsys® LH Assay is an in vitro diagnostic immunoassay for quantitative determination of human luteinizing hormone (LH) in serum and plasma. Device utilizes sandwich principle: 20 µL sample incubated with biotinylated monoclonal LH-specific antibody and ruthenium-labeled monoclonal LH-specific antibody; complex binds to streptavidin-coated microparticles. Reaction mixture aspirated into measuring cell; microparticles magnetically captured on electrode surface. Voltage application induces chemiluminescent emission measured by photomultiplier. Results calculated via instrument-specific calibration curve generated by 2-point calibration and master curve from reagent bar code. Used on Elecsys® 2010 instrument. Provides clinicians with quantitative LH levels to assist in endocrine assessment.

Clinical Evidence

Bench testing only. Method comparison study (N=166) vs. Enzymun-Test® LH showed high correlation (r=0.993). Precision studies (N=60 per level) demonstrated %CVs ranging from 0.81% to 5.17%. Lower detection limit 0.10 mIU/mL. Linearity 0.1–200 mIU/mL. Interference testing performed for bilirubin, hemoglobin, lipemia, biotin, and rheumatoid factor. Specificity testing showed <0.1% cross-reactivity with FSH, HCG, TSH, HGH, and HPL.

Technological Characteristics

Sandwich immunoassay; electrochemiluminescence detection; streptavidin-coated microparticles; biotinylated monoclonal antibodies; ruthenium complex label. Requires Elecsys® 2010 instrument. Calibration via 2-point method and reagent bar code. Quantitative measurement range 0.1–200 mIU/mL.

Indications for Use

Indicated for the in vitro quantitative determination of human luteinizing hormone (LH) in human serum and plasma.

Regulatory Classification

Identification

A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

Predicate Devices

• Enzymum® LH Assay (K900799)

Submission Summary (Full Text)

{0}

JAN 24 1997
K964694

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 8240
FAX 510 687 - 1850

Contact Person: Betsy Soares-Maddox
Date Prepared: November 19, 1996

## 2. Device name

Proprietary name: Elecsys® LH Assay

Common name: Electrochemiluminescence assay for the determination of human luteinizing hormone (LH).

Classification name: System, Test, Human Luteinizing Hormone

## 3. Predicate device

We claim substantial equivalence to the Enzymum® LH Assay (K900799).

## 4. Device Description

Sandwich principle. Total duration of assay: 18 minutes.

- 1st incubation (9min.): 20 µL of sample, a biotinylated monoclonal LH-specific antibody (75 µL) and a monoclonal LH-specific antibody labeled with a ruthenium complex (75 µL)** react to form a sandwich complex.
- 2nd incubation (9min.): after addition of streptavidin-coated microparticles (30 µL), the complex becomes bound to the solid phase via interaction of biotin and streptavidin.

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

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# 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 luteinizing hormone in human serum and plasma.

## 6. Comparison to predicate device

The Boehringer Mannheim Elecsys® LH 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® LH Assay (K900779).

The following table compares the Elecsys® LH Assay with the predicate device, Enzymun® LH 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 luteinizing hormone (LH)
- Sample type: Serum and plasma
- Antibody: Same pair of monoclonal mouse anti-LH antibodies
- Solid phase binding principle: Streptavidin/Biotin

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510(k) Summary, Continued

6. Comparison to predicate device cont.

Differences:

| Feature | Elecsys® LH | Enzymun-Test® LH |
| --- | --- | --- |
| Assay Standardization | Enzmun® LH | WHO # 80/552 |
| Detection method | 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. | Full calibration required every 2 weeks. One-point calibration required every run. |

Performance Characteristics:

| Feature | Elecsys® LH | | | Enzymun-Test® LH | | |
| --- | --- | --- | --- | --- | --- | --- |
| Precision | Modified NCCLS (mIU/mL): | | | Modified NCCLS (mIU/mL): | | |
| Level | Low | Mid | High | Low | Mid | High |
| N | 60 | 60 | 60 | 120 | 120 | 120 |
| Within-Run Mean | 0.54 | 9.38 | 50.72 | 3.6 | 13.5 | 59.5 |
| %CV | 1.82 | 1.13 | 0.81 | 2.9 | 3.8 | 1.5 |
| Total Mean | 0.54 | 9.38 | 50.72 | 3.6 | 13.5 | 59.5 |
| %CV | 5.17 | 1.97 | 1.99 | 4.4 | 4.7 | 3.9 |
| Lower Detection Limit | 0.10 mIU/mL | | | 0.50 mIU/mL | | |

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510(k) Summary, Continued

6. Comparison to predicate device, (cont.)

Performance Characteristics:

| Feature | Elecsys® LH | Enzymun-Test® LH |
| --- | --- | --- |
| Linearity | 0.1 - 200 mIU/mL (with a deviation from a linear line of ±10%) | 0.5 - 150 mIU/mL (with a deviation from a linear line of ±10%) |
| Method Comparison | Vs Enzymun-Test® LH
Least Squares
y = 1.00x - 0.199
r = 0.993
SEE = 1.141
N = 166

Passing/Bablok
y = 0.964x + 0.040
r = 0.993
SEE = 0.456
N = 166 | Vs Enzymun-Test® LH
Least Squares
y = 0.93x + 0.42
r = 0.953
SEE = 5.079
N = 62 |
| Interfering substances | No interference at: | No interference at: |
| Bilirubin | 25.0 mg/dL | 64.5 mg/dL |
| Hemoglobin | 1 g/dL | 1 g/dL |
| Lipemia | 1500 mg/dL | 1250 mg/dL |
| Biotin | 30 ng/mL | 40 ng/mL |
| Rheumatoid Factor | 1500 U/mL | no interference |
| Specificity | Level tested % Cross-reactivity | Level tested % Cross-reactivity |
| FSH | 300 mIU/mL < 0.1 | 200 mU/mL 0.00 |
| HCG | 600 IU/mL < 0.1 | 200 U/mL 0.00 |
| TSH | 300 μIU/mL < 0.1 | 100 μU/mL 0.00 |
| HGH | 600 μIU/mL < 0.1 | 200 ng/mL 0.00 |
| HPL | 13.80 pmol/mL < 0.1 | --- |