ELECSYS PROLACTIN ASSAY

K964748 · Boehringer Mannheim Corp. · CFT · Jan 21, 1997 · Clinical Chemistry

Device Facts

• Record ID: K964748
• Device Name: ELECSYS PROLACTIN ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: CFT · Clinical Chemistry
• Decision Date: Jan 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1625
• Device Class: Class 1

Intended Use

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

Device Story

Elecsys Prolactin Assay is an in vitro diagnostic immunoassay for quantitative prolactin measurement in human serum and plasma. The device utilizes a sandwich principle: 10μL sample reacts with biotinylated monoclonal prolactin-specific antibody and ruthenium-labeled monoclonal prolactin-specific antibody. Streptavidin-coated microparticles bind the complex to a solid phase. The mixture is aspirated into a measuring cell where microparticles are magnetically captured on an electrode. Voltage application induces chemiluminescent emission, measured by a photomultiplier. Results are calculated via a 2-point calibration curve and a master curve provided by reagent bar code. Used in clinical laboratory settings on the Elecsys 2010 instrument. Healthcare providers use the quantitative output to assess prolactin levels, aiding in the diagnosis and management of endocrine disorders. The assay provides improved sensitivity and dynamic range compared to traditional ELISA methods.

Clinical Evidence

Bench testing only. Performance evaluated via precision (N=60 per level), linearity (10-10,000 μIU/mL), and method comparison (N=99) against the predicate. Precision showed %CV between 1.9% and 3.4%. Method comparison yielded a correlation coefficient (r) of 0.9986. Interference testing performed for bilirubin, hemoglobin, lipemia, biotin, and rheumatoid factor. Specificity testing confirmed 0.00% cross-reactivity with HGH, HPL, HCG, TSH, FSH, and LH.

Technological Characteristics

Sandwich immunoassay using electrochemiluminescence. Reagents include biotinylated monoclonal prolactin-specific antibody and ruthenium-labeled monoclonal prolactin-specific antibody (Tris(2,2'-bipyridyl)ruthenium(II)). Solid phase uses streptavidin-coated microparticles. Detection via photomultiplier tube following magnetic capture on an electrode. Requires Elecsys 2010 instrument. Calibration via 2-point method and reagent bar code master curve.

Indications for Use

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

Regulatory Classification

Identification

A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

Predicate Devices

• Enzymun® Prolactin Assay (K900695)

Submission Summary (Full Text)

{0}

JAN 21 1997
K964748

# 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

Date Prepared: November 21, 1996 |
| 2. Device name | Proprietary name: Elecsys® Prolactin Assay

Common name: Electrochemiluminescence assay for the determination of prolactin.

Classification name: System, Test, Prolactin |
| 3. Predicate device | We claim substantial equivalence to the Enzymun® Prolactin Assay (K900695). |
| 4. Device Description | Sandwich principle. Total duration of assay: 18 minutes (37 °C).
• 1st incubation (9 min.): 10μL of sample, a biotinylated monoclonal prolactin-specific antibody (75 μL), and a monoclonal prolactin-specific antibody labeled with a ruthenium complex (75 μL)** react to form a sandwich complex.
• 2nd incubation (9 min.): after addition of streptavidin-coated microparticles (40 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 prolactin in human serum and plasma.

6. Comparison to predicate device

The Boehringer Mannheim Elecsys® Prolactin 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® Prolactin Assay (K900695).

The following table compares the Elecsys® Prolactin Assay with the predicate device, Enzymun® Prolactin 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 prolactin
- Sample type: Serum and plasma
- Antibody: Same pair of mouse monoclonal prolactin antibodies
- Solid phase binding principle: Streptavidin/Biotin
- Assay standardization: World Health Organization Standard (WHO) #84/500

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510(k) Summary, Continued

6. Comparison to predicate device cont.

Differences:

| Feature | Elecsys® Prolactin | Enzymun-Test® Prolactin |
| --- | --- | --- |
| Detection method | 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. |

Performance Characteristics:

| Feature | Elecsys® Prolactin | | | Enzymun-Test® Prolactin | | |
| --- | --- | --- | --- | --- | --- | --- |
| Precision | Modified NCCLS (μIU/mL): | | | Modified NCCLS (μIU/mL): | | |
| Level | Low | Mid | High | Low | Mid | High |
| N | 60 | 60 | 60 | 119 | 119 | 120 |
| Within-Run: Mean | 229.8 | 1843.5 | 4662.1 | 10.1 | 28.3 | 63.0 |
| % CV | 2.4 | 1.9 | 2.4 | 2.1 | 2.4 | 1.9 |
| Total: Mean | 229.8 | 1843.5 | 4662.1 | 10.1 | 28.3 | 63.0 |
| % CV | 3.1 | 3.4 | 3.3 | 4.5 | 2.7 | 2.2 |
| Lower Detection Limit | 10 μIU/mL | | | 27.56 μIU/mL | | |

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510(k) Summary, Continued

6. Comparison to predicate device, (cont.)

Performance Characteristics:

| Feature | Elecsys® Prolactin | | Enzymun-Test® Prolactin | |
| --- | --- | --- | --- | --- |
| Linearity | 10-10,000 μIU/mL (with a deviation from a linear line of ±10%) | | 27.56-6,360 mIU/mL (with a deviation from a linear line of ±10%) | |
| Method Comparison | Vs Enzymun-Test® Prolactin Least Squares
y = 1.14x - 33.36
r = 0.9986
SEE = 40.088
N = 99

Passing/Bablok
y = 1.101x - 19.40
r = 0.9986
SEE = 9.001
N = 99 | | Vs Enzymun-Test® Prolactin Least Squares
y = 0.79x + 2.63
r = 0.996
SEE = 3.764
N = 76 | |
| | | | | |
| Interfering substances | No interference at: | | No interference at: | |
| Bilirubin | 25 mg/dL | | 64.5 mg/dL | |
| Hemoglobin | 1 g/dL | | 1 mg/dL | |
| Lipemia | 1500 mg/dL | | 1250 mg/dL | |
| Biotin | 30 ng/mL | | 100 ng/mL | |
| Rheumatoid Factor | 1700 μIU/mL | | no interference | |
| Specificity | Level tested | % Cross-reactivity | Level tested | % Cross-reactivity |
| HGH | 200 mU/mL | 0.00 | 2 mU/mL | 0.00 |
| HPL | 100 ng/mL | 0.00 | 100 ng/mL | 0.00 |
| HCG | 1000 IU/mL | 0.00 | 625 IU/mL | 0.00 |
| TSH | 500 μIU/mL | 0.00 | 50 μIU/mL | 0.00 |
| FSH | 2 IU/mL | 0.00 | 38 IU/mL | 0.00 |
| LH | 1 IU/mL | 0.00 | 12.5 IU/mL | 0.00 |