(16 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device description, intended use, or any mention of AI, ML, or related concepts. The only information present is the predicate device, which is a blood control, not a device typically associated with AI/ML.
No
The provided information only lists a "Whole Blood Control" as a predicate device, which is typically used for calibration or quality control of diagnostic devices, not for therapeutic purposes. There is no information in the input that suggests a therapeutic function.
No
The information provided focuses on comparative devices (predicate devices) rather than directly describing the intended use or functionality of the device in question. Without details on the device's purpose or how it interacts with the human body to diagnose conditions, it cannot be confirmed as a diagnostic device.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description and intended use, making it impossible to determine if it is a software-only medical device.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic).
Here's why:
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Predicate Device: The presence of a predicate device, "HemoCue Whole Blood Control," is a strong indicator. HemoCue devices are well-known for performing in vitro diagnostic tests, specifically for measuring hemoglobin levels in blood. A "Whole Blood Control" is a substance used to verify the accuracy of such tests, which are inherently IVD procedures.
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Lack of Information: While the other sections are "Not Found," the presence of a predicate device in the IVD space is a significant clue. If the device were not an IVD, it would be unusual to list an IVD control as a predicate.
In summary: The primary evidence pointing towards this being an IVD is the listed predicate device, which is a control used in in vitro diagnostic testing. Without further information, this is the most compelling indicator.
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
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
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
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for "Direct Solutions". The word "DIRECT" is in large, bold, sans-serif font, with each letter slightly separated. Below "DIRECT" is a black rectangle containing the word "SOLUTIONS" in white, bold, sans-serif font.
OCT 16 1996 3908
Re: HemoCue HemoLin 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 HemoLin, which have been prepared in accordance with the FDA labeling requirements of 21 CFR 809.10.
Substantial equivalence of HemoLin control to devices already on the market
For the purposes of demonstrating substantial equivalency. HemoCue HemoLin 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 attached 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 temp. and 2-8℃), compatibility and noninterference 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 25℃, over periods ranging from 0 to 876 days, incorporating a variety of production lots.
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A precision study of five (5) levels of HemoCue HemoLin as compared to three (3) levels of 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 (1886 Voice: 1-800-729-8152 Fax: 508-692-5955 E-mail: eurotrol@directsolutions.com