ACS LH2 IMMUNOASSAY

K962041 · Ciba Corning Diagnostics Corp. · CEP · Jun 21, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962041
• Device Name: ACS LH2 IMMUNOASSAY
• Applicant: Ciba Corning Diagnostics Corp.
• Product Code: CEP · Clinical Chemistry
• Decision Date: Jun 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1485
• Device Class: Class 1

Intended Use

The intended use of ACS LH2 is for the quantitative determination of LH in serum using the Ciba Corning Automated Chemiluminescence Systems.

Device Story

Two-site chemilumometric (sandwich) immunoassay; utilizes monoclonal mouse anti-LH antibodies. Input: patient serum sample. Process: sample reacts with acridinium ester-labeled antibody and paramagnetic particle-coupled antibody; relative light units (RLUs) measured by ACS:180 system. Output: quantitative LH concentration. Used in clinical laboratory settings; operated by trained laboratory personnel. Results assist clinicians in evaluating reproductive health and endocrine function.

Clinical Evidence

Bench testing only. Accuracy evaluated using 689 samples (range 0.1–96.6 mIU/mL); correlation coefficient (r) = 0.97; regression equation: y = 0.93x + 0.87. Total precision (CV) ranged from 4.0% to 6.0%. Minimum detectable concentration is 0.07 mIU/mL; measurement range up to 200 mIU/mL.

Technological Characteristics

Non-competitive chemiluminescence immunoassay. Reagents: monoclonal mouse anti-LH antibodies (one acridinium ester-labeled, one paramagnetic particle-coupled). Platform: ACS:180 automated chemiluminescence system. Measurement principle: direct relationship between LH concentration and relative light units (RLUs).

Indications for Use

Indicated for quantitative determination of Luteinizing Hormone (LH) in human serum to aid in the assessment of reproductive function.

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

• ACS LH Immunoassay (K910198)

Submission Summary (Full Text)

{0}

Company Confidential
K962041

# JUN 21 1996

## Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

### 1. Submitter Information

Contact person: Thomas F. Flynn

Address: Ciba Corning Diagnostics Corp.
63 North Street
Medfield, MA 02052

Phone: [phone]
FAX [phone]
e-mail: [e-mail]

Date Summary Prepared: May 24, 1996

### 2. Device Information

Proprietary Name: ACS LH2 Immunoassay
Common Name: LH Immunoassay
Classification Name: Class I, Luteinizing hormone test system, 21 CFR 862.1485

### 3. Predicate Device Information

Name: ACS LH Immunoassay
Manufacturer: Ciba Corning Diagnostics Corp.
510(k) Number: K910198

### 4. Device Description

The Ciba Corning ASC LH2 assay is a two-site chemilumometric (sandwhich) assay which uses constant amounts of two antibodies that have specificity for the intact LH molecule. The first antibody or Lite Reagent is a monoclonal mouse anti-LH antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-LH antibody covalently coupled to paramagnetic particles. A direct relationship exists between the LH in a sample and the relative light units (RLUs) detected by the ACS:180 systems.

### 5. Statement of Intended Use

The intended use of ACS LH2 is for the quantitative determination of LH in serum using the Ciba Corning Automated Chemiluminescence Systems.

ACS LH2 510(k) Notification
May 22, 1996
2

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Company Confidential

## 6. Summary of Technological Characteristics

The Ciba Corning LH2 assay is a non-competitive chemiluminescence assay

## 7. Performance Data

### Sensitivity

The ACS LH2 assay measures LH concentrations up to 200 mIU/mL with a minimum detectable concentration of 0.07 mIU/mL.

### Accuracy

For 689 samples in the range of 0.1 to 96.6 mIU/mL, the correlation between the ACS LH2 assay and the reference method assay is described by the equation:

$$
\text{ACS LH2} = 0.93 \times (\text{reference method}) + 0.87
$$

Correlation coefficient (r) = 0.97

### Precision

Total precision (Total % CV) ranged from 4.0 to 6.0.

ACS LH2 510(k) Notification
May 22, 1996
3