(51 days)
The iQ 200 System is intended for analysis of urine chemistry, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis.
Urinalysis is ordered by physicians as a screening procedure for detection of possible abnormal metabolic or systemic disease, indicated by chemical composition of urine, and of potential renal or urinary tract disease or dysfunction, indicated by urine concentration and by the nature and distribution of urinary formed elements. Urine profile testing is commonly employed in the initial clinical evaluation of patients admitted for hospital care or undergoing physical examinations.
Routine urinalysis is also indicated in diagnosis of patients with possible renal or urinary tract infection, carcinoma, or other injury, as well as for monitoring the status and effectiveness of drug, radiation, or dietary therapy, and of post-surgical or posttherapeutic recovery.
The information produced by the iQ 200 System concerning the composition of patient urines is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Routine urinalysis findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.
The iQ 200 System is an in-vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ 200 Analyzer can be used as a stand-alone unit, or the results from the iQ 200 Analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.
The iQ Lamina Cradle is a new accessory to be used with the iQ Series of Urine Microscopy Analyzers (K022774). The iQ Lamina Cradle is connected to the iQ Series via a 5V DC USB bus, and is under software control of the desktop computer that is part of the iQ Series. The cradle contains a RFID transceiver and antenna. In simple terms, it recognizes a legitimate IRIS RFID tag embedded in the container label of each 7 liter iQ Lamina Bottle. The software tracks the consumption of iQ Lamina. Visual warning and error messages are displayed as flags in the system software. Audio alerts are communicated through the cradle's speaker. The tracking will alert the operator when a bottle is empty or when a bottle not containing an Iris RFID chip is being used.
The provided document pertains to the 510(k) submission for the "iQ®200 System with Lamina Cradle" by International Remote Imaging Systems, Inc. However, it explicitly states that performance studies are "Not applicable to the addition of Lamina Cradle" and "No clinical tests were performed with the addition of the Lamina Cradle."
Therefore, based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets specific acceptance criteria. The submission focuses on the Lamina Cradle as an accessory to an already cleared device (the iQ®200 System) and asserts substantial equivalence without new performance data for the accessory itself.
The document describes the Lamina Cradle as a new accessory to be used with the iQ Series of Urine Microscopy Analyzers. Its function is primarily to track the consumption of "iQ Lamina" (which appears to be a reagent or consumable used with the system) using an RFID transceiver. It provides visual and audio alerts for bottle status. Since this accessory’s function is tracking and alerting for consumables, and not directly involved in the analytical performance of the urinalysis system, no new performance studies or clinical tests were deemed necessary for its 510(k) clearance.
In summary, the provided text does not contain the requested information about acceptance criteria or a study demonstrating the device's performance against such criteria because, for this specific submission, those studies were considered "not applicable."
§ 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).