CEDIA N-ACETYLPROCAINAMIDE ASSAY

K963306 · Boehringer Mannheim Corp. · LAR · Oct 29, 1996 · Clinical Toxicology

Device Facts

• Record ID: K963306
• Device Name: CEDIA N-ACETYLPROCAINAMIDE ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: LAR · Clinical Toxicology
• Decision Date: Oct 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

Immunoassay for the in vitro quantitative determination of N-acetylprocainamide in human serum and plasma.

Device Story

The CEDIA N-acetylprocainamide Assay is a homogeneous enzyme immunoassay used for the quantitative measurement of N-acetylprocainamide in human serum and plasma. The device utilizes genetically engineered beta-galactosidase fragments that reassociate to form an active enzyme. In the presence of N-acetylprocainamide from a patient sample, the analyte competes with an analyte-conjugated enzyme fragment for antibody binding sites; this competition allows the inactive fragments to reassociate into an active enzyme. The active enzyme cleaves a substrate, producing a color change measured spectrophotometrically. The assay is performed on clinical chemistry analyzers (e.g., Hitachi 911) by laboratory technicians. The resulting concentration is used by clinicians to monitor therapeutic drug levels in patients, aiding in clinical decision-making regarding dosage adjustments.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (N=120 per level) and method comparison against the predicate (N=125). Precision showed %CVs ranging from 2.29% to 7.35%. Method comparison yielded a correlation coefficient (r) of 0.994 with a regression equation of y = 1.04x + 0.21. Interference testing demonstrated robustness against bilirubin, hemoglobin, lipemia, total protein, and rheumatoid factor. Cross-reactivity with metabolites was evaluated.

Technological Characteristics

Homogeneous enzyme immunoassay using genetically engineered beta-galactosidase fragments. Detection principle: Spectrophotometric measurement at 570 nm. Requires clinical chemistry analyzer (e.g., Hitachi 911). Analyte range: 0.6 - 30 µg/mL. Sample type: human serum and plasma.

Indications for Use

Indicated for the in vitro quantitative determination of N-acetylprocainamide in human serum and plasma for patients requiring therapeutic drug monitoring.

Regulatory Classification

Identification

A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Predicate Devices

• Abbott TDx® N-acetylprocainamide Assay (K830206)

Submission Summary (Full Text)

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10/10/96 17:58 510 674 8523 BMC CONCORD 006/014
K963306
OCT 29 1996

# 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

Contact Person: Betsy Soares-Maddox
Date Prepared: October 10, 1996

## 2. Device name
Proprietary name: CEDIA® N-acetylprocainamide Assay

Common name: Homogeneous enzyme immunoassay for the determination of N-acetylprocainamide.

Classification name: Enzyme immunoassay, N-acetylprocainamide

## 3. Predicate device
The Boehringer Mannheim CEDIA® N-acetylprocainamide is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Abbott TDx® N-acetylprocainamide Assay (K830206).

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# 510(k) Summary, Continued

## 4. Device Description

The CEDIA® N-acetylprocainamide Assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, N-acetylprocainamide in the sample competes with analyte conjugated to one inactive fragment of β-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive β-galactosidase fragments, and no active enzyme is formed.

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# 510(k) Summary, Continued

## 5. Intended use
Immunoassay for the in vitro quantitative determination of N-acetylprocainamide in human serum and plasma.

## 6. Comparison to predicate device
The Boehringer Mannheim CEDIA® N-acetylprocainamide Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Abbott TDx® N-acetylprocainamide Assay (K830206).

The following table compares the CEDIA® N-acetylprocainamide Assay with the predicate device, Abbott TDx® N-acetylprocainamide 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 N-acetylprocainamide
- Sample type: Serum and plasma
- Assay range: 0.6 - 30 µg/mL

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17:59
510 974 822
009/014

# 510(k) Summary, Continued

## 6. Comparison to predicate device cont.

### Differences:

| Feature | CEDIA®
N-acetylprocainamide | TDx
N-acetylprocainamide |
| --- | --- | --- |
| Reaction test principle | Spectrophotometric 570 nm | Fluorescence Polarization |
| Instrument required | Hitachi 911 | Abbott TDx |

### Performance Characteristics:

| Feature | CEDIA®
N-acetylprocainamide | | | TDx
N-acetylprocainamide | | |
| --- | --- | --- | --- | --- | --- | --- |
| Precision | Modified NCCLS (μg/mL): | | | NCCLS (μg/mL): | | |
| Level | Level 1 | Level 2 | Level 3 | Low | Mid | High |
| N | 120 | 120 | 120 | 120 | 120 | 120 |
| Within run mean | 1.91 | 4.41 | 10.75 | 4.06 | 9.18 | 23.80 |
| %CV | 5.84 | 3.35 | 2.29 | 3.3 | 1.7 | 2.3 |
| Total mean | 1.91 | 4.41 | 10.75 | 4.06 | 9.18 | 23.80 |
| %CV | 7.35 | 4.08 | 2.87 | 3.1 | 2.4 | 5.5 |

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# 510(k) Summary, Continued

## 6. Comparison to predicate device, (cont.)

### Performance Characteristics:

| Feature | CEDIA®
N-acetylprocainamide | TDx
N-acetylprocainamide |
| --- | --- | --- |
| Lower Detection Limit | 0.6 μg/dL | 0.6 μg/dL |
| Linearity | 0.6 - 30 μg/dL | 0.0 - 30.0 μg/dL |
| Method Comparison | Vs Abbott TDx
N-acetylprocainamide

**Least Squares**
y = 1.04x + 0.21
r = 0.994
N = 125

**Deming's:**
y = 1.04x + 0.18
r = 0.9940
N = 125 | Vs Enzyme Immunoassay
N-acetylprocainamide

y = 1.06x - 0.60
r = 0.986
N = 96 |

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18:00
5. 214 8320
011 014

# 510(k) Summary, Continued

## 6. Comparison to predicate device, (cont.)

### Performance Characteristics:

| Feature | CEDIA®
N-acetylprocainamide | TDx
N-acetylprocainamide |
| --- | --- | --- |
| Interfering substances | No interference at:
(±10% of error) | No interference at: |
| Bilirubin | 66 mg/dL | 15 mg/dL |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Lipemia | 1200 mg/dL | 1200 mg/dL |
| Total Protein | 13 g/dL | 9.5 mg/dL |
| Rheumatoid Factor | 85 IU/mL | N/A |
| Specificity | % Cross-reactivity | % Cross-reactivity |
| Procainamide | 0.1 | None detected |
| Desethyl-N-Acetyl-procainamide | 21.7 | 18.2 |
| Desethyl-procainamide | 0.1 | Not tested |