ENZYMUN-TEST PSA

K965085 · Boehringer Mannheim Corp. · LTJ · Mar 19, 1997 · Immunology

Device Facts

• Record ID: K965085
• Device Name: ENZYMUN-TEST PSA
• Applicant: Boehringer Mannheim Corp.
• Product Code: LTJ · Immunology
• Decision Date: Mar 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

Enzyme-linked immunosorbent assay for the quantitative determination of Prostate-Specific Antigen (PSA) in serum and plasma.

Device Story

Enzymun-Test PSA is an ELISA 1-step sandwich assay for quantitative PSA determination in human serum and plasma. The device utilizes streptavidin-coated tube walls, biotinylated anti-PSA antibodies, and peroxidase (POD)-labeled monoclonal anti-PSA antibodies to form a sandwich complex. Following separation of unbound conjugate, POD activity is measured photometrically via chromogen/substrate (H2O2) reaction. Color intensity, proportional to PSA concentration, is measured against a blank. The assay is designed for use on Boehringer Mannheim Automated Immunoassay Systems (e.g., ES 300). Results are calculated via a calibration curve. The device assists clinicians in the prognosis and management of prostate cancer patients.

Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-T2 protocol; within-run CVs ranged from 2.6% to 6.0% and total CVs from 4.0% to 15.2% across pools. Lower detection limit is 0.05 ng/ml with an assay range of 0.05–50 ng/ml. Interference testing showed no interference up to 700 mg/dl hemoglobin, 64.5 mg/dl bilirubin, and 1250 mg/dl Intralipid.

Technological Characteristics

ELISA 1-step sandwich assay; streptavidin-coated tubes; peroxidase-labeled monoclonal antibody conjugate; photometric detection; automated immunoassay system (ES 300).

Indications for Use

Indicated for the quantitative measurement of prostate-specific antigen (PSA) to aid in the prognosis and management of patients with prostate cancer.

Regulatory Classification

Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Predicate Devices

• Hybritech Tandem®-R PSA (P850048)

Submission Summary (Full Text)

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K965085

MAR 19 1997

# 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
9115 Hague Rd.
Indianapolis, IN 46250
[phone]

Contact Person: LeeAnn Chambers
Date Prepared: November 15, 1996

2) Device name Proprietary name: Enzymun-Test® PSA

Common name: tumor associated antigen immunological test system

Classification name: Prostate-specific antigen (PSA), immunological test system for the management of prostate cancer

3) Predicate device We claim substantial equivalence to the Hybritech Tandem®-R PSA (P850048).

4) Device Description The Enzymun-Test PSA test principle is an ELISA/1-step sandwich assay using streptavidin technology. The assay procedure is designed to run on the Boehringer Mannheim Automated Immunoassay Systems.

In the first incubation step (immunological reaction) the PSA in the sample reacts with the biotinylated anti-PSA antibodies, which are in turn bound to the streptavidin-coated tube wall. The PSA is also bound to the peroxidase (POD)-labeled monoclonal antibody (anti-PSA POD-conjugate) to form a sandwich complex. The quantity of antibody-PSA POD complex formed is a measure of the PSA content of the sample. The unbound POD-conjugate is removed along with serum constituents in the separation step.

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510(k) Summary, Continued

4) Device Description, (cont.)

The activity of the POD bound to the tube wall is determined photometrically after the addition of the chromogen and the substrate H₂O₂ (from sodium perborate). In the indicator reaction, the chromophore formed is a dark green cation whose concentration is directly proportional to the PSA concentration in the sample. The color intensity that develops within a fixed period of time is measured against the substrate/chromogen blank.

The test results are determined from a calibration curve derived using the standards provided in the kit.

5) Intended use

Enzyme-linked immunosorbent assay for the quantitative determination of Prostate-Specific Antigen (PSA) in serum and plasma.

6) Comparison to predicate device

The Boehringer Mannheim Enzymun-Test PSA is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Hybritech Tandem-R PSA.

The following table compares the Enzymun-Test PSA with the predicate device Hybritech Tandem-R PSA.

Similarities:

- Intended use: for the quantitative measurement of prostate-specific antigen (PSA) to aid in the prognosis and management of patients with prostate cancer.
- Both assays use mouse monoclonal antibodies to bind and detect PSA
- Both assays use 50 μl sample volume.

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510(k) Summary, Continued

6) Comparison to predicate device, (cont.)

Differences:

| Feature | Enzymun-Test PSA | Hybritech Tandem-R PSA |
| --- | --- | --- |
| Sample type | Human serum and plasma | Human serum |
| Detection method | Enzyme linked immunosorbent assay | Radioimmunoassay |
| Instrument required | ES 300 or other ES system | γ-PHOTON System or gamma counter |
| Calibration | Full calibration curve every 2 weeks with a 1 point recalibration with every run | Full calibration curve with every run |

Performance Characteristics:

| Feature | Enzymun-Test PSA | | | | | Hybritech Tandem-R PSA | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Precision | NCCLS EP5-T2 protocol within run: | | | | | within run: (20 replicates from 3 runs) | | | |
| | Pool 1 | Pool 2 | Pool 3 | TMI | TMII | 1 | 2 | 3 | |
| | N 63 | 63 | 63 | 63 | 63 | N 60 | 60 | 60 | |
| | x̄ 0.28 | 3.07 | 39.64 | 1.19 | 6.43 | x̄ 2.98 | 6.99 | 36.34 | |
| | CV 6.0 | 3.0 | 2.6 | 3.4 | 3.0 | CV 2.7 | 1.6 | 1.1 | |
| | Total: | | | | | between run: | | | |
| | Pool 1 | Pool 2 | Pool 3 | TMI | TMII | 1 | 2 | 3 | |
| | N 63 | 63 | 63 | 63 | 63 | N 201 | 201 | 201 | |
| | x̄ 0.28 | 3.07 | 39.64 | 1.19 | 6.43 | x̄ 3.05 | 7.14 | 35.71 | |
| | CV 15.2 | 4.3 | 4.4 | 5.0 | 4.0 | CV 5.6 | 3.2 | 3.7 | |
| | | | | | | inter-laboratory: | | | |
| | | | | | | 1 | 2 | 3 | 4 |
| | | | | | | N 8 | 8 | 8 | 8 |
| | | | | | | x̄ 3.06 | 13.27 | 31.48 | 83.59 |
| | | | | | | CV 5.56 | 5.12 | 4.42 | 2.64 |
| Sensitivity | Lower detection limit: 0.05 ng/ml | | | | | Minimum detectable conc.: 0.15 ng/ml | | | |
| Assay range (LDL to highest standard) | 0.05 ng/ml - 50 ng/ml | | | | | 0.15 ng/ml - 100 ng/ml | | | |
| Interfering Substances | No interference up to: | | | | | No interference up to: | | | |
| hemoglobin | 700 mg/dl | | | | | 200 mg/dl | | | |
| bilirubin | 64.5 mg/dl | | | | | 25 mg/dl | | | |
| lipemia | 1250 mg/dl (Intralipid) | | | | | 2320 mg/dl | | | |