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K Number
K972868
Device Name
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
Manufacturer
BIONOSTICS, INC.
Date Cleared
1997-08-28

(24 days)

Product Code
JJY
Regulation Number
862.1660
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This material is intended for use to monitor the measurements of: a. pH and pCO2 and pO2 in blood gas analyzers, - b. Na, K, Cl, Li, Ca++, and Mg++ in electrolyte analyzers, and; - c. glucose, lactate, BUN and creatinine in analyzers which measure these metabolites. The Control is provided at three clinically significant levels to make possible verification of instrument performance at different points for each analyte. This product is for In Vitro Diagnostic Use only.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Bionostics, Inc. regarding their "Blood Gas/Electrolyte/Glucose, Lactate, BUN, and Creatinine Control" product.

This document

  • determines substantial equivalence for a specific in-vitro diagnostic control product.
  • does not contain any information about a study, acceptance criteria, or device performance data.
  • does not describe any AI/ML components.
  • does not mention any details about sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot extract the requested information to fill in the table and answer the questions. The text is purely a regulatory communication.

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.