(151 days)
No
The summary describes a chemical reagent for quantitative determination using colormetric methodology and does not mention AI or ML.
No
The device is a reagent intended for the quantitative determination of salicylate in plasma and serum, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is intended for the quantitative determination of salicylate in plasma and serum, which is a measurement used to aid in diagnosis or patient management.
No
The device description clearly states it is a "reagent," which is a chemical substance used in a laboratory test. This indicates a physical component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of salicylate in plasma and serum." This is a diagnostic test performed on biological samples (plasma and serum) outside of the body (in vitro).
- Device Description: The description mentions it's a "reagent" used for a "colormetric methodology," which is a common technique in laboratory diagnostics.
- Performance Studies: The performance study describes testing biological samples (49 samples) to demonstrate correlation with another diagnostic device.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The proposed and the predicate device are intended for use as quantitative determination of salicylate in plasma and serum.
Product codes
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Device Description
The Paramax® Salicylate Reagent and DuPont aca Salicylate Reagent are based on colormetric methodology.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
coefficient was 0.999
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.