NOVA GLUCOSE CONTROL SOLUTIONS

• K Number: K033433
• Device Name: NOVA GLUCOSE CONTROL SOLUTIONS
• Manufacturer: NOVA BIOMEDICAL CORP.
• Date Cleared: 2004-01-02 ( 66 days)
• Product Code: JJX
• Regulation Number: 862.1660
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Nova Glucose Control Solution assayed quality control material is used to verify the performance of BD Glucose Monitoring Systems and the BD/Medtronic MiniMed Blood Glucose Monitoring Systems. This control is an OTC product intended for use in the home setting. The Nova Glucose Control Solutions are for in vitro diagnostic use ONLY.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the Nova Glucose Control Solution. It describes the device, its intended use, and states that it has been found substantially equivalent to predicate devices. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria, as it is a regulatory clearance document, not a scientific study report.

Therefore, I cannot extract the detailed information requested in the prompt based on the provided text. The document refers to "performance" in the "Indications for Use" section (to "verify the performance of BD Glucose Monitoring Systems"), but it does not define specific performance metrics, acceptance criteria, or present a study comparing these criteria to the device's actual performance.

The questions below cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available.
6. If a standalone performance (algorithm only) was done: Not applicable, as this is a control solution, not an algorithm.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not applicable, as this is a control solution, not a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

Regulation Number and Section

§ 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.