(541 days)
K/DEN, Chemtrak's AccuMeter Cholesterol Self Test
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No
There is no mention of AI, ML, or related concepts in the provided text. The predicate device is a cholesterol self-test, which is typically a chemical assay, not an AI/ML-driven device.
No
The device is described as a "Cholesterol Self Test," which is a diagnostic tool, not a therapeutic one. Therapeutic devices are designed for treatment, while this device measures a health parameter.
No
The provided information about the predicate device, "Chemtrak's AccuMeter Cholesterol Self Test," suggests that the device measures cholesterol levels. Measuring cholesterol levels is a diagnostic function, as it provides information used to identify or monitor a disease or condition. Therefore, this device is a diagnostic device.
Unknown
The provided 510(k) summary lacks crucial information about the device description and intended use, making it impossible to determine if it is software-only. The predicate device, a cholesterol self-test, suggests a potential hardware component, but without the device description, this is speculative.
Based on the information provided, it is highly likely that this device is an IVD. Here's why:
- Predicate Device: The listed predicate device, "Chemtrak's AccuMeter Cholesterol Self Test," is a well-known example of an IVD. It's a test performed outside the body (in vitro) to measure a substance (cholesterol) in a biological sample (blood) for diagnostic purposes.
- Intended User / Care Setting: The indication of "home use" further supports the idea of a self-testing device, which is a common application for IVDs.
While the "Intended Use / Indications for Use" section is missing, the strong evidence from the predicate device points towards this being an IVD.
To be absolutely certain, you would need to see the actual "Intended Use / Indications for Use" statement. However, based on the available information, the conclusion is strongly in favor of it being 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)
Chemtrak's AccuMeter Cholesterol Self Test
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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SUMMARY OF SAFETY AND EFFECTIVENE
ACCUTREND® CHOLESTEROL TEST MAR - 6 1996
The Accutrend® Cholesterol Test is substantially equivalent to Chemtrak's AccuMeter Cholesterol Self Test. Both systems are used to measure total cholesterol in whole blood. The procedure for both tests entails applying a cappilary blood sample to a dry chemistry test strip or cartridge. Both test systems utilize non-wipe technologies. The cholesterol esterase reaction is measured in both tests. Both test systems have lot-specific coding for each lot of test strips or cartridges. Finally, both the Accutrend and AccuMeter systems are cholesterol screening devices which have been cleared specially for home use.
Boehringer Mannheim Corporation 9115 Hague Road Indianapolis, Indiana 46256
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