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510(k) Data Aggregation

    K Number
    K170200
    Device Name
    Carbon Dioxide Reagent Set
    Manufacturer
    Teco Diagnostics, Inc.
    Date Cleared
    2017-06-01

    (129 days)

    Product Code
    KHS
    Regulation Number
    862.1160
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K070251
    Why did this record match?
    Device Name :

    Carbon Dioxide Reagent Set

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Teco Carbon Dioxide Reagent Set is a device which is intended for measurement of Carbon Dioxide level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status in the assessment of acid-base balance of metabolic alkalosis or respiratory acidosis.

    Device Description

    Teco Carbon Dioxide Reagent Set is a single reagent kit. Reagent contains Good's buffer, phosphoenolpyruvate (PEP), phosphoenolpyruvate carboxylase (PEPC), malate dehydrogenase (MDH), magnesium ions, NADH analog, nonreactive stabilizer, preservative, and Buffer. Approximately 90% of carbon dioxide present in serum is in the form of bicarbonate. The measurement of bicarbonate is useful in the assessment of disturbances of acid-base balance resulting from metabolic or respiratory causes.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Teco Carbon Dioxide Reagent Set, based on the provided document:

    Acceptance Criteria and Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance (Teco Carbon Dioxide Reagent Set)
    Linearity/Reportable RangeRange over which the assay demonstrates a linear relationship to the analyte concentration. (Predicate: 2.0 to 40.0 mmol/L)8.7 to 40.0 mmol/L (linear up to 64 mmol/L)
    Accuracy/CorrelationComparison to a predicate device, typically measured by linear regression with a high R-squared value. (Predicate: $y = 0.965x + 1.200$)$y = 0.9785x + 0.2636$, $R^2 = 0.9925$, and $R = 0.9962$
    Detection Limit (LoQ)The lowest concentration at which the analyte can be quantitatively determined with acceptable precision (
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