DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110

K032573 · Dade Behring, Inc. · LAR · Oct 31, 2003 · Clinical Toxicology

Device Facts

• Record ID: K032573
• Device Name: DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
• Applicant: Dade Behring, Inc.
• Product Code: LAR · Clinical Toxicology
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Indications for Use

The method is used on the Dade Behring Dimension clinical chemistry system for the quantitative determination of procainamide in serum or plasma. Measurements may be used in the diagnosis and treatment of procainamide overdose, and in therapeutic drug monitoring. The device is for in vitro diagnostic use. It is intended for prescription use.

Device Story

In vitro diagnostic test for quantitative procainamide measurement in serum or plasma; utilizes prepackaged flexible plastic reagent cartridges on Dimension clinical chemistry systems. Employs homogenous particle-enhanced turbidimetric inhibition immunoassay (PETINIA); procainamide in sample competes with latex-bound procainamide for monoclonal antibody binding sites; aggregation rate inversely proportional to procainamide concentration. System performs bichromatic turbidimetric readings at 340 nm and 700 nm. Used in clinical laboratory settings by trained personnel. Output provides procainamide concentration (ug/mL) to assist clinicians in therapeutic drug monitoring and overdose management.

Clinical Evidence

Bench testing only. Split-sample comparative study (n=89) between subject device and predicate (aca® PROC test pack) yielded a slope of 1.03, intercept of -0.02 ug/mL, and correlation coefficient of 0.997.

Technological Characteristics

PETINIA immunoassay; latex particle procainamide conjugate; monoclonal procainamide-specific antibody. Bichromatic turbidimetric detection (340 nm/700 nm). Form factor: flexible plastic reagent cartridge for Dimension clinical chemistry system. Assay range: 0.5 - 20.0 ug/mL. Sample volume: 2 uL.

Indications for Use

Indicated for the quantitative measurement of procainamide in serum or plasma for patients undergoing procainamide therapy or suspected of procainamide overdose.

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

• Dade Behring aca® PROC analytical test pack (K833384)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K032573

B. Analyte:
Procainamine

C. Type of Test:
Quantitative

D. Applicant:
Dade Behring, Inc.

E. Proprietary and Established Names:
Dimension Procainamide (PROC) Flex reagent cartridge method

F. Regulatory Information:
1. Regulation section:
862.3320
2. Classification:
II
3. Product Code:
LAR
4. Panel:
Toxicology (91)

G. Intended Use:
1. Intended use(s):
Refer to Indications for use.

2. Indication(s) for use:
The method is used on the Dade Behring Dimension clinical chemistry system for the quantitative determination of procainamide in serum or plasma.
Measurements may be used in the diagnosis and treatment of procainamide overdose, and in therapeutic drug monitoring.

The device is for in vitro diagnostic use.
It is intended for prescription use.

3. Special condition for use statement(s):
None applicable.

4. Special instrument Requirements:
The device is for use on Dimension clinical chemistry systems.

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Performance was demonstrated in this submission on the Dimension RxL analyzer.

# H. Device Description:

The Flex® reagent cartridge method consists of prepackaged ready-to-use reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system.

# I. Substantial Equivalence Information:

1. Predicate device name(s):

Dade Behring aca procainamide test pack

2. Predicate K number(s):

K833384

3. Comparison with predicate:

Both devices are for measurement of the same analyte(s) in the same matrix, and are run on automated analyzers.

The reagent formulations vary between the two devices.

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Manufacturer | Dade Behring | Dade Behring |
| Differences | | |
| Item | Device | Predicate |
| Instrument | Dimension analyzer | aca analyzer |
| Technology | Petina, turbidometric | EMIT, colorimetric |

# J. Standard/Guidance Document Referenced (if applicable):

Refer to individual sections.

# K. Test Principle:

The methodology is based on a homogenous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique which uses a latex particle procainamide conjugate (PR) and monoclonal procainamide specific antibody (Ab). Procainamide present in the sample competes with procainamide on the particles for available antibody, thereby decreasing the rate of aggregation. The rate of aggregation is inversely proportional to the concentration of procainamide in the sample. The rate of aggregation measured using bichromatic turbidimetric readings at $340\mathrm{nm}$ and $700\mathrm{nm}$ . The concentration is determined by means of a mathematical extrapolation through the use of calibrators run with the assay.

# L. Performance Characteristics (if/when applicable):

1. Analytical performance:

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a. Precision/Reproducibility:
(All performance was established on the Dimension RxL analyzer.

The number of lots of product used was not specified in the studies.

Typical precision observed for the Dimension® Procainamide (PROC) Flex® reagent cartridge method is summarized in the table below:

| | Mean | | Standard Deviation (%CV) | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | μg/mL | [μmol/L] | Within Run | | | Total | | |
| BioRad Liquichek® TDM Control Level 1 | 2.7 | 11.4 | 0.11 | 0.47 | (4.3) | 0.13 | 0.55 | (4.9) |
| BioRad Liquichek® TDM Control Level 2 | 5.8 | 24.7 | 0.08 | 0.34 | (1.4) | 0.15 | 0.63 | (2.6) |
| BioRad Liquichek® TDM Control Level 3 | 10.4 | 44.1 | 0.09 | 0.38 | (0.9) | 0.31 | 1.31 | (3.0) |
| Low Pool (4 μg/mL) | 3.76 | 15.98 | 0.16 | 0.68 | (4.2) | 0.16 | 0.68 | (4.2) |
| Mid Pool (12 μg/mL) | 11.64 | 49.47 | 0.17 | 0.72 | (1.5) | 0.28 | 1.19 | (2.4) |
| High Pool (18 μg/mL) | 17.61 | 74.84 | 0.21 | 0.89 | (1.2) | 0.43 | 1.83 | (2.5) |

Sample pools were analyzed in duplicate for 20 days. The within-run and total coefficients of variation (%CV) were calculated by the analysis of variance method according to the National Committee of Clinical Laboratory Standards (NCCLS) Guideline EP5-A (February 1999). Liquichek® is a registered trademark of BioRad, Bio-Rad Laboratories, Irvine, California 92618.

b. Linearity/assay reportable range:

Support for linearity is provided through visual examination of graph contrasting expected versus observed results. Expected results were established through spiking of serum samples. Samples in the study ranged from 0.29 to 20.23 micrograms per mL.

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Linearity claims are also supported by visual examination of replicate measurements of the calibrators plotted against expected results.

c. Traceability (controls, calibrators, or method):

Calibrators are specified in the labeling but are not supplied in the kit. Calibrators were cleared under 510K number k032574.

Five levels of calibrator material, ranging in concentration from 0-20 microgram per mL are intended for use with the assay.

Traceability of the assay is not discussed by the sponsor.

d. Detection limit:

Sensitivity of the assay is 0.5 micrograms/mL.

To determine analytical sensitivity, the sponsor assayed the negative 0 calibrator 20 times. The mean concentration and standard deviation was calculated. The analytical sensitivity was estimated by adding 2 standard deviations to the average of the readings.

e. Analytical specificity:

Cross-reactivity of Desethylprocainamine is estimated to be 12%. The method used to establish this estimate is not described.

The sponsor evaluated over 50 endogenous and exogenous compounds and determined that their systemic bias was less than 10%. The compounds are listed in the package insert.

f. Assay cut-off:

Not applicable. This is a quantitative assay for a therapeutic drug.

2. Comparison studies:

a. Method comparison with predicate device:

A total of 89 serum samples were evaluated by the candidate device and by the predicate device. The range of sample concentrations is 1.0 – 16.0 ug/mL and are adequately distributed across the reportable range of the assay.

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Sample selection: The method used to select samples for inclusion in the study was not specified.

Number of study sites: not specified

Description of the site(s): not specified

Type of study site: not specified.

Operator description: not specified

Number of instruments used: not specified

Regression analysis results of the method comparison are:

Slope = 1.03

Intercept = -0.02 ug/mL

Correlation Coefficient = 0.997

b. Matrix comparison:

In order to evaluate for potential bias between the claimed matrices, the sponsor analyzed 20 replicate split samples of serum, sodium heparin, lithium heparin, and EDTA specimens. Each set of plasma results was compared to serum results. The sample concentrations spanned the reportable range of the assay. There is no apparent bias between the claimed plasma types and serum.

3. Clinical studies:

a. Clinical sensitivity:

Not applicable. Clinical studies are not necessary for this device type.

b. Clinical specificity:

Not applicable. Clinical studies are not necessary for this device type.

c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:

Not applicable.

5. Expected values/Reference range:

The therapeutic range for this assay is 4-12 micrograms/mL of procainamide.

M. Conclusion:

I recommend that this device be found substantially equivalent to the predicate device.