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K Number
K060619
Device Name
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
Manufacturer
DIAZYME LABORATORIES
Date Cleared
2006-07-21

(135 days)

Product Code
KHS,JJX
Regulation Number
862.1160
Type
Traditional
Panel
Clinical Chemistry
Reference & Predicate Devices
k990754
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Diazyme Carbon Dioxide Enzymatic Assay Kit, in conjunction with Diazyme Carbon Dioxide Calibrator, are intended for the quantitative determination of carbon dioxide (CO2) in serum and plasma. Diazyme Carbon Dioxide Enzymatic Assay Kit contains a single-point calibrator. The calibrator, along with 0.9% saline as a zero reference, is used to generate a linear graph that will be used in the calculation of carbon dioxide concentrations in unknown samples. Diazyme Carbon Dioxide Control Set has controls for normal carbon dioxide level and abnormal carbon dioxide level. The controls are used as reference samples for checking the functionality of the Diazyme Carbon Dioxide Enzymatic Assay.

Device Description

Not Found

AI/ML Overview

I am unable to find the acceptance criteria or results of a study that proves the device meets acceptance criteria in the provided document. The document primarily contains a 510(k) summary, an FDA clearance letter, and an "Indications for Use" statement for the Diazyme Carbon Dioxide Enzymatic Assay Kit.

This type of document typically focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the way described in your request. While it mentions the calibrator and controls, it does not provide:

  • A table of acceptance criteria and reported device performance.
  • Information about sample sizes for test sets, data provenance, or ground truth establishment.
  • Details on expert involvement, adjudication methods, or MRMC studies.
  • Information regarding standalone algorithm performance, training set size, or training ground truth.

§ 862.1160 Bicarbonate/carbon dioxide test system.

(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.