(151 days)
The Paramax® Salicylate Reagent is intended for use as quantitative determination of salicylate in plasma and serum.
The Paramax® Salicylate Reagent is based on colormetric methodology.
{
"acceptance_criteria_and_performance": {
"table": [
{
"criterion": "Correlation with predicate device",
"acceptance_level": "High correlation coefficient",
"reported_performance": "Correlation coefficient = 0.999"
},
{
"criterion": "Regression equation",
"acceptance_level": "Regression equation indicating substantial equivalence",
"reported_performance": "Paramax® value = (1.16 x aca value) - 1.8 mg/dL"
}
],
"study_summary": "The study demonstrated substantial equivalence between the Paramax® Salicylate Reagent and the DuPont aca Salicylate Reagent based on the high correlation coefficient (0.999) and a regression equation of Paramax® value = (1.16 x aca value) - 1.8 mg/dL."
},
"sample_size_test_set": 49,
"data_provenance": "Not specified (likely clinical samples, but country/retrospective/prospective not mentioned in snippet).",
"number_of_experts_ground_truth": "Not applicable; the ground truth for this comparison study was established by the predicate device (DuPont aca Salicylate Reagent).",
"qualifications_of_experts": "Not applicable",
"adjudication_method": "Not applicable",
"mrmc_comparative_effectiveness_study": "No, this was a device-to-device correlation study, not an MRMC study involving human readers.",
"standalone_performance_study": "Yes, the study evaluated the standalone performance of the Paramax® Salicylate Reagent by comparing its results to a predicate device's results on the same samples.",
"type_of_ground_truth": "Predicate device's results (DuPont aca Salicylate Reagent). The predicate device's measurements are considered the reference for establishing substantial equivalence.",
"sample_size_training_set": "Not applicable; this is a device validation study, not a machine learning model training.",
"how_ground_truth_for_training_set_established": "Not applicable"
}
{0}------------------------------------------------
KA64715 APR 25 1997
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
PARAMAX® SALICYLATE REAGENT
Dade International, Inc. 2173 NW 99 Avenue Miami, Fl 33172 Betty Hernandez-Labadie Contact Person: (305) 392-5618 (305) 392-5622 (fax)
Trade or Proprietary Name: Paramax® Salicylate Reagent Salicylate Reagent Common or Usual Name: Colormetric Salicylate, 21 CFR 862.3830 Classification Name: 1025506 Registration Number: 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.
{1}------------------------------------------------
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.
§ 862.3830 Salicylate test system.
(a)
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.(b)
Classification. Class II.