(32 days)
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No
The summary focuses on traditional performance studies like stability and precision, with no mention of AI, ML, or related concepts.
No
The provided text only mentions studies related to glucose stability and precision measurements, which are characteristic of a diagnostic or monitoring device, not a therapeutic device. There is no information suggesting the device treats or cures a condition.
Yes
Explanation: The "Summary of Performance Studies" section describes tests related to glucose stability and precision using "HemoCue B-Glucose analyzers," which implies the device is used to measure glucose levels, a diagnostic function.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The "Summary of Performance Studies" mentions testing related to glucose stability and precision using analyzers and controls, suggesting potential hardware involvement, but without a device description, a definitive conclusion cannot be reached.
Based on the provided text, there is strong evidence to suggest this device is an IVD (In Vitro Diagnostic). Here's why:
- Mentions "glucose stability study" and "precision study of five (5) levels of HemoCue GlucoTrol as compared to three (3) levels of HemoCue Whole Blood Control". These types of studies, involving the analysis of biological samples (glucose, whole blood) and controls, are characteristic of IVD devices used for diagnostic testing.
- Mentions "HemoCue B-Glucose analyzers". HemoCue is a well-known manufacturer of point-of-care diagnostic devices, particularly for blood analysis. The mention of their analyzers further supports the IVD nature of the device being described.
- The context of a 510(k) submission. 510(k) submissions are required for medical devices, and the types of performance studies described (stability, precision with controls) are standard for IVD devices.
While the "Intended Use / Indications for Use" section is "Not Found", the details about the performance studies strongly point towards a device designed to analyze biological samples for diagnostic purposes, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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:
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An open vial and closed vial glucose stability study.
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A day-to-day precision study.
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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