OPUS HLH

K962866 · Behring Diagnostics, Inc. · CEP · Aug 23, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962866
• Device Name: OPUS HLH
• Applicant: Behring Diagnostics, Inc.
• Product Code: CEP · Clinical Chemistry
• Decision Date: Aug 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1485
• Device Class: Class 1

Intended Use

OPUS hLH is a fluorogenic enzyme assay for use with the OPUS analyzers used in the quantitative measurement of luteinizing hormone (LH) in serum or plasma.

Device Story

OPUS hLH is a sandwich binding immunoassay for quantitative measurement of luteinizing hormone (LH) in serum or plasma. Device utilizes test modules containing solid phase rabbit anti-LH polyclonal antibody on glass fiber, anti-LH monoclonal antibody/alkaline phosphatase conjugate, and 4-methylumbelliferylphosphate substrate. Operated on OPUS analyzers in clinical laboratory settings. Analyzers process samples, perform fluorogenic enzyme assay, and provide quantitative LH results to clinicians. Results assist in evaluating reproductive health and endocrine function.

Clinical Evidence

Bench testing only. Precision: Intra-assay %CV 4.56-6.32%; Inter-assay %CV 4.55-5.64%. Accuracy: Correlation with commercial immunoassay (n=143, r=0.98, slope 1.06, y-intercept 1.06). Recovery: 95.3-98.1%. Interference: No interference from TSH (1,000 mIU/L), FSH (1,000 mIU/ml), or Prolactin (1,000 ng/ml). Cross-reactivity: hCG (<50,000 mIU/ml) and hGH (<1,000 ng/ml) showed <0.6% cross-reactivity.

Technological Characteristics

Sandwich binding immunoassay. Solid phase: rabbit anti-LH polyclonal antibody immobilized on glass fiber. Detection: anti-LH monoclonal antibody/alkaline phosphatase conjugate. Substrate: 4-methylumbelliferylphosphate. Energy source: fluorogenic enzyme reaction measured by OPUS analyzer. Form factor: sealed test module.

Indications for Use

Indicated for the quantitative measurement of luteinizing hormone (LH) in human serum or plasma 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

• Abbott IMX LH test system

Submission Summary (Full Text)

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1962864

AUG 23 1996

# 510(k) Summary of Safety and Effectiveness for OPUS hLH

1. Manufacturer Name, Address, phone number, contact name and date of preparation.

Manufacturer: Behring Diagnostics Inc.
151 University Ave
Westwood, MA 02090
617-320-3000
Contact name: Ruth C. Forstadt

Date of preparation: July 22, 1996

2. Device Name/Classification

OPUS hLH Reagents for hLH assay

Classification number: Class II (862.1485)

3. Identification of the legally marketed device to which the submitter claims equivalence.

Abbott IMX LH test system

4. Proposed Device Description

OPUS hLH is based on the principle of sandwich binding immunoassay. Each test module contains a solid phase anti-LH polyclonal antibody immobilized onto glass fiber. An anti-LH monoclonal antibody/alkaline phosphatase conjugate solution and a wash/substrate solution (4-methylumbelliferylphosphate) are sealed in separate wells within the test module.

5. Proposed Device Intended Use

OPUS hLH is a fluorogenic enzyme assay for use with the OPUS analyzers used in the quantitative measurement of luteinizing hormone (LH) in serum or plasma.

6. Medical device to which equivalence is claimed and comparison information:

The OPUS hLH test system is substantially equivalent in intended use to the Abbott IMX LH test system. Both products are in vitro diagnostic test systems intended for use as a quantitative measurement of human luteinizing hormone (LH) in serum or plasma. The Abbott IMX LH, like the proposed product, employs the principle of two site or sandwich

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immunoassay. Both methods use a labeled antibody for the quantitative measurement of luteinizing hormone (LH) in human serum or plasma. The OPUS hLH and Abbott IMX LH are both based on a six level calibrator system.

The OPUS hLH differs from the Abbott IMX LH in that the solid phase capture antibody is a mouse monoclonal in the Abbott test, while the solid phase capture antibody is a rabbit monoclonal in the OPUS test. Also, the Abbott IMX LH includes a tri-level control, where as the OPUS hLH test system does not include a control.

## 7. Proposed Device Performance Characteristics

Precision of the OPUS hLH test system was evaluated on an OPUS Immunoassay System. Intra-assay precision was determined by the evaluation of three serum pools in replicates of 20 each. %CV's ranged from 4.56% to 6.32%.

Inter-assay precision was determined by the evaluation of three levels of two sets of control sera assayed in triplicate twice a day for five days for a total of thirty replicates. %CV's ranged from 4.55% to 5.64%.

No interference was detected by levels of TSH up to 1,000 mIU/L, FSH up to 1,000 mIU/ml and Prolactin up to 1,000 ng/ml when evaluated using OPUS hLH. hCG at levels up to 50,000 mIU/ml and hGH at levels up to 1,000 ng/ml showed less than 0.6% crossreactivity with the OPUS LH assay.

## Accuracy by Correlation

OPUS hLH was compared to a commercially available immunoassay by evaluation of 143 serum samples ranging from 0.79-109 mIU/ml. A correlation coefficient of 0.98 was obtained with a y-intercept value of 1.06 and a slope of 1.06.

## Accuracy by Recovery

Recovery was determined by adding LH at different concentrations to a normal human serum pool with a known endogenous LH concentration. The samples were assayed using OPUS hLH in replicates of three. Percent recovery ranged from 95.3% to 98.1%.

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