(30 days)
Tri-Point™ BRAND Liquimmune® Liquid Assayed Immunoassay Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions and for use as a consistent test sample of known concentration for monitoring assay convent use as a consistent toot bankplo of not of the many of control with patient serum in immunological ueterminations: intractions . The user can compare speciments when assaying for any of the noted of time as a means of evaluating analytical recovered values over and instrument performance.
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This is a letter acknowledging receipt and clearance of a 510(k) submission, not a study report. Therefore, it does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth that you're requesting.
The document indicates that the device, "Liquimmune® Liquid Assayed Immunoassay Control," is intended for use as a quality control material to monitor immunoassay conditions. As such, it's a control product, not a diagnostic device that would typically undergo a study to demonstrate sensitivity, specificity, or other performance metrics against a clinical ground truth in the way a diagnostic algorithm or device would.
The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided in the 510(k) submission, which would include data demonstrating the control's stability, reproducibility, and commutability (how well it behaves like patient samples in an assay). However, those specific study details are not present in this letter.
To provide the information you've requested, one would need access to the actual 510(k) submission (K011731) and its supporting documentation, which contains the detailed studies and data demonstrating the performance of the Liquimmune® control.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.