(37 days)
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No
The summary describes a control solution for a hemoglobin analyzer and focuses on its chemical composition, stability, and performance compared to a predicate control. There is no mention of AI or ML.
No
The text describes a control product used for comparison and validation of HemoCue devices, not a device used for diagnosis, treatment, or prevention of disease.
No
This device is a control solution ("HemoCue HemoTrol control") used for quality control of another medical device (HemoCue Whole Blood Control, measured on HemoCue B-Hemoglobin analyzers), not for diagnosing a medical condition in a patient.
No
The device description and performance studies clearly indicate this is a physical control solution used with a HemoCue analyzer, not a software-only device.
Based on the provided text, the device described, HemoCue HemoTrol control, is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states it is a "control" product used for comparison with another "Whole Blood Control". Control materials are a fundamental component of in vitro diagnostic testing, used to verify the accuracy and precision of the test system.
- Comparison to a Known IVD: It is compared to the "HemoCue Whole Blood Control, manufactured for HemoCue by Streck Laboratories, Inc.". The fact that it's being compared to a product manufactured by a company known for diagnostic controls further indicates its IVD nature.
- Performance Studies: The description of performance studies, including shelf life validation, open vial stability, compatibility with an analyzer, and comparable precision and accuracy, are all typical studies conducted for IVD products to demonstrate their reliability and suitability for diagnostic use.
- Matrix and Chemical Composition: The mention of similar "matrix, chemical composition, technological characteristics" to a known control product reinforces its role in mimicking biological samples for diagnostic testing.
Therefore, the HemoCue HemoTrol control is designed to be used in vitro (outside the body) to assess the performance of a diagnostic test (in this case, likely a hemoglobin test on a HemoCue analyzer), which is the definition of an In Vitro Diagnostic device.
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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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§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Image /page/0/Picture/1 description: The image shows a logo with the word "DIRECT" stacked on top of the word "SOLUTIONS". The words are in a bold, sans-serif font. The word "DIRECT" is white, and the word "SOLUTIONS" is also white, but it is set against a black background. The overall design is simple and eye-catching.
OV -6 1996
Re: HemoCue HemoTrol 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 HemoTrol, which have been prepared in accordance with the FDA labeling requirements of 21 CFR 809.10.
Substantial equivalence of HemoTrol to devices already on the market
For the purposes of demonstrating substantial equivalency, HemoCue HemoTrol 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 included 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 enclosed which provides supporting data relative to the product shelf life, open vial stability (room temperature 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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Six shelf life validation time studies, at 2-8℃ and/or 25℃, over periods ranging from 0 to 876 days, incorporating a variety of production lots.
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A precision study of three (3) levels each of HemoCue HemoTrol as compared to HemoCue Whole Blood Control (manufactured by Streck Laboratories), measured on three (3) different HemoCue B-Hemoglobin analyzers, in replicates of 10.
www.directsolutions.com
Direct Solutions, P.O. Box 900, Westford, MA 01886 Voice: 1-800-729-8152 Fax: 508-692-5955 E-mail: eurotrol@directsolutions.com