(224 days)
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No
The device description and performance studies focus on the physical properties of the control material and its performance in checking the functionality of the Sysmex UF-100 analyzer, with no mention of AI or ML.
No
UF-Check is a quality control material intended for use with an automated urine analyzer, not for treating any medical condition.
No
Explanation: UF-Check is a quality control material for an automated urine analyzer, not a diagnostic device itself. Its purpose is to ensure the analyzer performs correctly, not to diagnose medical conditions in patients.
No
The device description clearly states that UF-Check is a suspension of particles in a liquid medium supplied in glass bottles, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that UF-Check is for "quality control of Sysmex UF-100™ automated urine analyzer." The Sysmex UF-100 is described as an "in vitro medical device for use in urinalysis in clinical laboratories." Quality control materials for IVD devices are themselves considered IVDs.
- Device Description: The description details a suspension of particles in a liquid medium, designed to mimic biological components found in urine. This is consistent with the nature of a control material used in in vitro testing.
- Care Setting: The intended user is "clinical laboratories," which is the typical setting for performing in vitro diagnostic tests.
While UF-Check itself doesn't directly diagnose a patient's condition, it is an essential component in ensuring the accuracy and reliability of an IVD device (the Sysmex UF-100) used for diagnosis. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
UF-Check™ is intended for use in the quality control of Sysmex UF-100™ automated urine analyzer.
Product codes
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Device Description
UF-Check is a suspension of particles representing red blood cells, white blood cells, epithelial cells, casts, and bacteria in a liquid medium. Sysmex UF-Check is supplied in glass bottles containing 47 ml volumes. Three bottles - one of each level- are packaged in one box.
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
Within Run Precision, Within Lot Discussion of Tests and Test Results: Precision, and Long Term Stability Studies were performed. Results were consistent and gave acceptable performance. UF-Check performs like a five-part differential control which when run in the QC mode gives values for the measurement of parameters. When run in the QC mode, all systems are checked for performance such as correct addition of dye, correct particle sizing, and correct enumeration of elements.
Key Metrics
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Predicate Device(s)
Ret-Check (K900484), SF-Check (K952245)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads 'K961054', and the text at the bottom reads 'Oct. 28, 1996'. The handwriting is clear and legible, with a slightly informal style. The text appears to be a date and some kind of identification number.
Image /page/0/Picture/1 description: The image shows the word "Sysmex" in a bold, sans-serif font. The letters are all capitalized, and the word is slightly slanted to the right. There is a trademark symbol in the upper right corner of the word. The word is black and the background is white.
510(k) Summary of Safety and Effectiveness Sysmex UF-Check™
| 510(k) Submitter: | Sysmex Corporation
Gilmer Road 6699 RFD
Long Grove, IL 60047-9596 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Nina Gamperling, MBA, MT(ASCP)
Supervisor, Clinical and Regulatory Affairs
Phone: (847) 726-3675; Fax: (847)726-3669 |
| Date Prepared: | June 24, 1996 |
| Names of Device: | |
| Trade Name: | UF-Check |
| Common Name: | Assayed Urinalysis Control |
| Classification Name: | Urinalysis quality control mixture |
Ret-Check (K900484) Predicate Device: SF-Check (K952245)
UF-Check is a suspension of particles representing red blood cells, Description: white blood cells, epithelial cells, casts, and bacteria in a liquid medium. Sysmex UF-Check is supplied in glass bottles containing 47 ml volumes. Three bottles - one of each level- are packaged in one box.
UF-Check™ is intended for use in the quality control of Sysmex Intended Use: UF-100™ automated urine analyzer. The Sysmex UF-100 is a in vitro medical device for use in urinalysis in clinical laboratories to replace microscopic review of normal and abnormal specimens and to flag specimens containing certain abnormalities.
Like Ret-Check, UF-Check is intended as an Comparison with Predicate Device: assayed control for an automated analyzer which uses the same flow cytometry technology. Like SF-Check, UF-Check is intended as an assayed control for an automated analyzer to perform like a five-part differential control. These controls are manufactured to contain measureable elements in a liquid medium. The UF-Check is different from the predicate products in the chemical composition of elements to simulate an urine sample rather than a blood sample.
Within Run Precision, Within Lot Discussion of Tests and Test Results: Precision, and Long Term Stability Studies were performed. Results were consistent and gave acceptable performance. UF-Check performs like a five-part differential control which when run in the QC mode gives values for the measurement of parameters. When run in the QC mode, all systems are checked for performance such as correct addition of dye, correct particle sizing, and correct enumeration of elements.
Conclusions Drawn from Tests: Study results show UF-Check to be consistently reproducible and stable for the entire product dating. UF-Check is a safe and effective urinalysis control when used as instructed in the product package insert.