ELECSYS FSH ASSAY

K964693 · Boehringer Mannheim Corp. · CGJ · Dec 16, 1996 · Clinical Chemistry

Device Facts

• Record ID: K964693
• Device Name: ELECSYS FSH ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: CGJ · Clinical Chemistry
• Decision Date: Dec 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1300
• Device Class: Class 1

Intended Use

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

Device Story

Elecsys FSH Assay is an immunoassay for quantitative determination of FSH in human serum and plasma. It utilizes a sandwich principle: sample, biotinylated monoclonal FSH-specific antibody, and ruthenium-labeled monoclonal FSH-specific antibody react to form a complex. Streptavidin-coated microparticles bind the complex to a solid phase. The mixture is aspirated into a measuring cell; microparticles are magnetically captured on an electrode. Voltage application induces chemiluminescent emission, measured by a photomultiplier. Results are calculated via a calibration curve generated by 2-point calibration and a master curve from reagent bar codes. Used in clinical laboratory settings on the Elecsys 2010 instrument. Provides quantitative FSH levels to assist healthcare providers in assessing reproductive health and endocrine function.

Clinical Evidence

Bench testing only. Method comparison study (N=160) against Enzymun-Test FSH showed high correlation (r=0.998). Precision evaluated using modified NCCLS protocols; within-run %CV ranged 1.75-1.95% and total %CV 3.69-5.26%. Lower detection limit 0.10 mIU/mL. Linearity 0.10-200 mIU/mL. Specificity testing showed <0.1% cross-reactivity with LH, HCG, TSH, HGH, and HPL. Interference testing performed for bilirubin, hemoglobin, lipemia, biotin, and rheumatoid factor.

Technological Characteristics

Sandwich immunoassay; electrochemiluminescence detection. Uses biotinylated monoclonal mouse anti-FSH antibodies and ruthenium-labeled monoclonal mouse anti-FSH antibodies. Solid phase: streptavidin-coated microparticles. Instrument: Elecsys 2010. Calibration: 2-point calibration with master curve via reagent bar code. Assay duration: 18 minutes.

Indications for Use

Indicated for the in vitro quantitative determination of human follicle stimulating hormone (FSH) in human serum and plasma.

Regulatory Classification

Identification

A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

Predicate Devices

• Enzymun® FSH Assay (K900763)

Submission Summary (Full Text)

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DEC 16 1996

BOEHRINGER MANNHEIM CORPORATION

K964693

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® FSH Assay

Common name: Electrochemiluminescence assay for the determination of human follicle stimulating hormone (FSH).

Classification name: System, Test, Human Follicle Stimulating Hormone |
| 3. Predicate device | We claim substantial equivalence to the Enzymun® FSH Assay (K900763). |
| 4. Device Description | Sandwich principle. Total duration of assay: 18 minutes.
•1st incubation (9 min.): 40 μL of sample, a biotinylated monoclonal FSH-specific antibody (80 μL) and a monoclonal FSH-specific antibody labeled with a ruthenium complex (50 μL)** react to form a sandwich complex.
•2nd incubation (9 min.): 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 follicle stimulating hormone in human serum and plasma.

6. Comparison to predicate device

The Boehringer Mannheim Elecsys® FSH 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® FSH Assay (K900763).

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

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510(k) Summary, Continued

6. Comparison to predicate device cont.

Differences (continued):

| Feature | Elecsys® FSH | Enzymun-Test® FSH |
| --- | --- | --- |
| Assay Standardization | Enzymun-Test® FSH | WHO 78/549 |
| 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 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® FSH | | | Enzymun-Test® FSH | | |
| --- | --- | --- | --- | --- | --- | --- |
| Precision | Modified NCCLS (mIU/mL): | | | Modified NCCLS (mIU/mL): | | |
| Level | Low | Mid | High | Low | Mid | High |
| N | 60 | 60 | 60 | 120 | 119 | 120 |
| Within-Run: Mean | 1.20 | 11.1 | 103.0 | 8.7 | 13.8 | 30.7 |
| %CV | 1.75 | 1.95 | 1.80 | 2.1 | 1.8 | 1.2 |
| Total: Mean | 1.20 | 11.1 | 103.0 | 8.7 | 13.8 | 30.7 |
| %CV | 5.26 | 3.69 | 5.08 | 2.3 | 2.6 | 3.1 |
| 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® FSH | Enzymun-Test® FSH |
| --- | --- | --- |
| Linearity | 0.10-200 mIU/mL (with a deviation from a linear line of ±10%) | 0.50-150 mIU/mL (with a deviation from a linear line of ±10%) |
| Method Comparison | Vs Enzymun-Test® FSH
Least Squares
y = 1.10 + 0.11
r = 0.998
SEE = 1.552
N = 160

Passing/Bablok
y = 1.09x + 0.21
r = 0.998
SEE = 0.504
N = 160 | Vs Enzymun-Test® FSH
Least Squares
y = 0.96x + 0.04
r = 0.993
SEE = 3.37
N = 76 |
| Interfering substances
Bilirubin
Hemoglobin
Lipemia
Biotin
Rheumatoid Factor | No interference at:
25 mg/dL
1 g/dL
1500 mg/dL
30 ng/mL
1500 IU/mL | No interference at:
64.5 mg/dL
1 g/dL
1250 mg/dL
90 ng/mL
no interference |
| Specificity
LH
HCG
TSH
HGH
HPL | Level tested % Cross-reactivity
1040 mIU/mL < 0.1
600 IU/mL < 0.1
600 μIU/mL < 0.1
600μIU/mL < 0.1
300 ng/mL < 0.1 | Level tested % Cross-reactivity
--- 0.00
--- 0.00
--- 0.00
--- 0.00
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