CEDIA PROCAINAMIDE ASSAY

K962099 · Boehringer Mannheim Corp. · LAR · Aug 27, 1996 · Clinical Toxicology

Device Facts

• Record ID: K962099
• Device Name: CEDIA PROCAINAMIDE ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: LAR · Clinical Toxicology
• Decision Date: Aug 27, 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 procainamide in human serum and plasma.

Device Story

CEDIA® Procainamide Assay is a homogeneous enzyme immunoassay for quantitative measurement of procainamide in human serum and plasma. Input: patient serum or plasma sample. Principle: competitive binding assay using genetically engineered β-galactosidase fragments; procainamide in sample competes with analyte-conjugated enzyme fragment for antibody binding sites; reassociation of inactive fragments forms active enzyme proportional to analyte concentration; color change measured spectrophotometrically at 570 nm. Used in clinical laboratory settings on automated analyzers (e.g., Hitachi 911). Output: quantitative procainamide concentration. Healthcare providers use results to monitor therapeutic drug levels and adjust dosage, aiding in patient management and toxicity prevention.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (N=120 per level), linearity (0.4–20 μg/mL), and method comparison against the predicate (N=122, y=1.04x+0.03, r=0.9914). Interference testing performed for bilirubin, hemoglobin, lipemia, protein, and rheumatoid factor. Specificity evaluated via cross-reactivity studies with N-acetyl-procainamide and other metabolites.

Technological Characteristics

Homogeneous enzyme immunoassay using genetically engineered β-galactosidase fragments. Detection method: spectrophotometric (570 nm). Form factor: reagent kit for use on automated clinical chemistry analyzers (e.g., Hitachi 911).

Indications for Use

Indicated for the in vitro quantitative determination of procainamide in human serum and plasma for patients undergoing procainamide therapy.

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® Procainamide Assay (K834464)

Submission Summary (Full Text)

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K962099
AUG 27 1996
Diagnostics

# 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

Contact Person: Mary Koning

Date Prepared: May 24, 1996

## 2. Device name

Proprietary name: CEDIA® Procainamide Assay

Common name: Homogeneous enzyme immunoassay for the determination of procainamide.

Classification name: Enzyme immunoassay, procainamide

## 3. Predicate device

The Boehringer Mannheim CEDIA® Procainamide 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® Procainamide Assay (K834464).

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Diagnostics

# 510(k) Summary, Continued

## 4. Device Description

The CEDIA® Procainamide 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, procainamide 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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Diagnostics

# 510(k) Summary, Continued

5. Intended use
Immunoassay for the in vitro quantitative determination of procainamide in human serum and plasma.

6. Comparison to predicate device
The Boehringer Mannheim CEDIA® Procainamide 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® Procainamide Assay (K834464).

The following table compares the CEDIA® Procainamide Assay with the predicate device, Abbott TDx® Procainamide 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 procainamide
- Sample type: Serum and plasma
- Assay range: $0.420 \, \mu\mathrm{g/mL}$

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Diagnostics

# 510(k) Summary, Continued

## 6. Comparison to predicate device cont.

### Differences:

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

### Performance Characteristics:

| Feature | CEDIA® Procainamide | | | TDx Procainamide | | |
| --- | --- | --- | --- | --- | --- | --- |
| Precision | Modified NCCLS (μg/mL) | | | Modified NCCLS (μg/mL): | | |
| Level | Level 1 | Level 2 | Level 3 | Low | Mid | High |
| N | 120 | 120 | 120 | 80 | 80 | 80 |
| Within-Run | 2.6 | 6.2 | 10.8 | 2.07 | 6.92 | 15.13 |
| %CV | 1.7 | 1.7 | 1.4 | 2.5 | 1.9 | 2.2 |
| Total | 2.6 | 6.2 | 10.8 | 2.07 | 6.92 | 15.13 |
| %CV | 3.1 | 3.0 | 2.8 | 5.4 | 4.2 | 4.6 |

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Diagnostics

# 510(k) Summary, Continued

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

Performance Characteristics:

| Feature | CEDIA® Procainamide | TDx Procainamide |
| --- | --- | --- |
| Lower Detection Limit | 0.4 μg/dL | 0.1 μg/dL |
| Linearity | 0.4 - 20 μg/dL (with a deviation from a linear line of ±10%) | 0.0 - 20.0 μg/dL |
| Method Comparison | Vs Abbott TDx Procainamide
Least Squares
y = 1.04x + 0.03
r = 0.9914
SEE = 0.42
N = 122

Deming's:
y = 1.04x - 0.01
r = 0.9914
SEE = 0.30
N = 122 | Vs Enzyme Immunoassay Procainamide
Least Squares
y = 1.01x - 0.18
r = 0.990
N = 262 |

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Diagnostics

# 510(k) Summary, Continued

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

### Performance Characteristics:

| Feature | CEDIA® Procainamide | TDx Procainamide |
| --- | --- | --- |
| Interfering substances | No interference at: | No interference at: |
| Bilirubin | 66 mg/dL | 15 mg/dL |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Lipemia | 1000 mg/dL | 1200 mg/dL |
| Protein | 6.5 g/dL Albumin | 9.5 mg/dL |
| Rheumatoid Factor | 10 g/dL IgG | N/A |
| Specificity | % Cross-reactivity | % Cross-reactivity |
| N-Acetyl-procainamide | 1.0 | 1.0 |
| Desethyl-N-Acetyl-procainamide | 0.1 | None Detected |
| Desethyl procainamide | 16.3 | 15 |
| Procaine HCl | 1.7 | N/A |

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