PARAMAX SALICYLATE REAGENT

K964715 · Dade Intl., Inc. · DKJ · Apr 25, 1997 · Clinical Toxicology

Device Facts

• Record ID: K964715
• Device Name: PARAMAX SALICYLATE REAGENT
• Applicant: Dade Intl., Inc.
• Product Code: DKJ · Clinical Toxicology
• Decision Date: Apr 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3830
• Device Class: Class 2

Indications for Use

The proposed and the predicate device are intended for use as quantitative determination of salicylate in plasma and serum.

Device Story

Paramax® Salicylate Reagent; in vitro diagnostic reagent for quantitative salicylate measurement in plasma and serum; utilizes colorimetric methodology; used on Paramax® analytical systems; provides salicylate concentration values to clinicians; aids in monitoring salicylate levels; supports clinical decision-making regarding toxicity or therapeutic management.

Clinical Evidence

Bench testing only. Correlation study performed using 49 clinical samples compared against DuPont aca Salicylate Reagent. Results: correlation coefficient 0.999; regression equation: Paramax® value = (1.16 x aca value) - 1.8 mg/dL.

Technological Characteristics

Colorimetric reagent system; quantitative assay for salicylate; designed for use on automated clinical chemistry analyzers (Paramax® system).

Indications for Use

Indicated for the quantitative determination of salicylate in human plasma and serum for clinical diagnostic purposes.

Regulatory Classification

Identification

A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

Predicate Devices

• DuPont aca Salicylate Reagent (K771805)

Submission Summary (Full Text)

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K964715 APR 25 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

## PARAMAX® SALICYLATE REAGENT

Dade International, Inc.
2173 NW 99 Avenue
Miami, Fl 33172
Contact Person: Betty Hernandez-Labadie
[phone]
[phone] (fax)

**Trade or Proprietary Name:** Paramax® Salicylate Reagent
**Common or Usual Name:** Salicylate Reagent
**Classification Name:** Colormetric Salicylate, 21 CFR 862.3830

**Registration Number:**

**1025506**
Dade International, Inc.
2173 NW 99 Avenue
Miami, Fl 33172

**1017272**
Dade International, inc.
1851 Delaware Parkway
Miami, Fl 33125

**2649587**
Dade International Puerto Rico Building 187-67
Road 115
KM 22.6
Aguada, P.R. 00602

The Paramax® Salicylate Reagent is substantially equivalent to its predecessor, which was cleared to market on K771805. The proposed and the predicate device are intended for use as quantitative determination of salicylate in plasma and serum.

The Paramax® Salicylate Reagent and DuPont aca Salicylate Reagent are based on colormetric methodology.

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# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
## PARAMAX® SALICYLATE REAGENT (con't)

The technological characteristics of the predicate device are similar to those previously described for the proposed device.

The correlation between the Paramax® Salicylate Reagent and Dupont aca Salicylate Reagent was demonstrated by testing 49 samples on a Paramax® and a DuPont aca System. The correlation coefficient was 0.999, and the regression equation was Paramax® value = (1.16x aca value) - 1.8 mg/dL. The data indicates that the results obtained by both reagents are substantially equivalent.