K Number

Device Name

Manufacturer

DIRECT SOLUTIONS

Date Cleared

1996-11-01

(32 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Device Description

Not Found

AI/ML Overview

This document is a 510(k) summary for the HemoCue GlucoTrol, a control solution for glucose meters, and does not describe a clinical study for a medical device that measures a physiological state or disease. Therefore, much of the requested information (acceptance criteria for a device's performance, sample sizes for test/training sets, expert involvement, MRMC studies, standalone performance, ground truth types) is not applicable in the context of this submission, which focuses on demonstrating substantial equivalence of a control solution to an existing control solution.

However, I can extract the relevant information from the provided text regarding the demonstration of substantial equivalency for the HemoCue GlucoTrol control solution.

Here's the breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:

1. A table of acceptance criteria and the reported device performance

The document does not specify formal "acceptance criteria" in the sense of performance thresholds for a diagnostic device (e.g., sensitivity, specificity). Instead, it focuses on demonstrating comparability to an existing predicate device (HemoCue Whole Blood Control) in terms of various characteristics for a control solution.

The "performance" is implicitly demonstrated through stability, precision, and compatibility studies. There are no numerical performance metrics provided in this summary that would typically be associated with a diagnostic device.

Acceptance Criteria (Implicit for a Control Solution)	Reported Device Performance (HemoCue GlucoTrol)
Similar in matrix, chemical composition, intended use, packaging.	Confirmed to be similar to HemoCue Whole Blood Control (manufactured by Streck Laboratories) in these aspects.
Product shelf life stability.	Supported by an open vial and closed vial glucose stability study. (Specific data/results are not provided in this summary).
Open vial stability (room temp. and 2-8℃).	Supported by an open vial stability study. (Specific data/results are not provided in this summary).
Compatibility and non-interference with the intended analyzer.	Supported by test data. (Specific data/results are not provided in this summary. The intended analyzer is the HemoCue B-Glucose analyzer).
Comparable precision and accuracy to the predicate device.	Supported by a day-to-day precision study and a precision study comparing five (5) levels of HemoCue GlucoTrol to three (3) levels of HemoCue Whole Blood Control (Streck Laboratories), measured on five different HemoCue B-Glucose analyzers, in replicates of six (6). (Specific data/results are not provided in this summary, but the claim of comparability is made based on these studies).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set:
- For the precision study comparing GlucoTrol to the predicate: "five (5) levels of HemoCue GlucoTrol as compared to three (3) levels of HemoCue Whole Blood Control (manufactured by Streck Laboratories), measured on five different HemoCue B-Glucose analyzers, in replicates of six (6)."
  - This means for the GlucoTrol: 5 levels * 5 analyzers * 6 replicates = 150 measurements.
  - For the predicate: 3 levels * 5 analyzers * 6 replicates = 90 measurements.
- For other studies (open vial, closed vial stability, day-to-day precision), specific sample sizes are not detailed in this summary, other than generally being "test data."
Data Provenance: Not specified in the summary. Given the companies (HemoCue, Streck Laboratories) and the submission to FDA, it is highly likely the data were generated in the US or Europe, but this is not explicitly stated.
Retrospective or Prospective: Not specified, but typically, stability and precision studies for a control solution like this would be conducted prospectively in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This is a control solution, not a diagnostic device requiring expert interpretation of results to establish ground truth about a patient's condition. The "ground truth" for a control solution is its specified analyte concentration, and the validation focuses on stability and precision around that concentration.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods are relevant for studies involving human interpretation or complex disease diagnosis, not for the analytical performance of a control solution in a laboratory setting.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This submission is for a control solution, which does not involve human readers interpreting cases or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. This is for a control solution, not an algorithm or a diagnostic device, so the concept of "standalone performance" in this context is not applicable. The performance described is the analytical performance of the control solution itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to the assigned values or target concentrations for glucose levels in the control solution. These values would have been established through a highly accurate reference method during the manufacturing process of the control solution. The testing then verifies that the control solution maintains these values over time and exhibits acceptable precision when measured by the intended analyzer.

8. The sample size for the training set

N/A. Control solutions generally do not have a "training set" in the machine learning sense. The studies described are validation and characterization studies.

9. How the ground truth for the training set was established

N/A. See point 8.

Summary

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K964053

Image /page/0/Picture/1 description: The image shows a logo with the word "DIRECT" on the top line and "SOLUTIONS" on the bottom line. The word "DIRECT" is in a simple, sans-serif font, with each letter evenly spaced. The word "SOLUTIONS" is in a bolder, rounded font, and it is set against a black background.

NOV - 1 1996

Re: HemoCue GlucoTrol 510(k) Notification

SMDA Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Representative Labels, Labeling and Advertisements

Included in this submission are samples or copies of the vial labels, box labeling, product description/instructions for use, and assay values for GlucoTrol, which have been prepared in accordance with the FDA labeling requirements of 21 CFR 809.10.

Substantial equivalence of GlucoTrol control to devices already on the market

For the purposes of demonstrating substantial equivalency, HemoCue GlucoTrol control is compared to the HemoCue Whole Blood Control, manufactured for HemoCue by Streck Laboratories, Inc., 14306 Industrial Road, Omaha, Nebraska, 68144. Product descriptions, intended use and assay values for this product are provided for comparison.

These two products are similar in matrix, chemical composition, technological characteristics, intended use, and packaging specifications.

Information and Data Supportive of Substantial Equivalency Claim

In addition to the product descriptions and intended use insert sheets referenced above, further evidence is provided which offers supporting data relative to the product shelf life, open vial stability (room temp. and 2-8℃), compatibility and non-interference with the intended analyzer, and comparable precision and accuracy as compared to the Streck Laboratories manufactured product. Test data include:

An open vial and closed vial glucose stability study.
A day-to-day precision study.
A precision study of five (5) levels of HemoCue GlucoTrol as compared to three (3) levels of HemoCue Whole Blood Control (manufactured by Streck Laboratories), measured on five different HemoCue B-Glucose analyzers, in replicates of six (6).

www.directsolutions.com

Direct Solutions, P.O. Box 900, Westford, MA (1886 Voice: 1-800-729-8152 Fax: 508-692-5955 E-mail: eurotrol@directsolutions.com

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.