(277 days)
The B.R.A.H.M.S.PCT LIA is an immunoluminometric assay (ILMA) used to determine the concentration of PCT (procalcitonin) in human serum and plasma.
The B.R.A.H.M.S PCT LIA is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock.
B-R A-H-S PCT LIA is an immunoluminometric assay (ILMA) used to determine the concentration of Procalcitonin (PCT) in human serum and plasma. Two antigen-specific monoclonal antibodies that bind PCT (the antigen) at two different binding sites (the calcitonin and katacalcin segments) are added in excess. One of these antibodies is luminescence labeled (the tracer), and the other is fixed to the inner walls of the tube (coated tube system). During the course of incubation, both antibodies react with PCT molecules in the sample to form "sandwich complexes". As result the luminescence labeled antibody is bound to the inner surface of the tube. Once the reaction is completed, the excess tracer is completely removed from the tube and discarded. Then, the amount of residual tracer on the test-tube wall is quantified by measuring the luminescence signal using a suitable luminometer and the B·R·A·H·M·S Basiskit LIA reagents. The intensity of the luminescence signal (RLU) is directly proportional to the PCT concentration in the sample. After a standard curve has been established using standards with known antigen concentrations (calibrated against recombinant intact human PCT), the unknown PCT concentrations in patient serum or plasma samples can then be quantitated by comparison of test values with the curve.
Here's a breakdown of the acceptance criteria and the study details for the B·R·A·H·M·S PCT LIA device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a codified format with target values. Instead, it presents performance characteristics and clinical study results that demonstrate the device's utility for its intended use. I will present the performance characteristics provided as "reported device performance."
| Performance Characteristic | Reported Device Performance |
|---|---|
| Analytical Sensitivity | 0.1 ng/ml |
| Functional Assay Sensitivity (FAS) | 0.3 ng/ml |
| Total Precision (%CV) | 5.3 - 16.6 % CV |
| Within Run Precision (%CV) | 2.4 - 10 % CV |
| High Dose Hook Effect | Does not have an effect on patient assignment to reference ranges for PCT concentrations up to 4000 ng/ml. (If a PCT result above the highest standard is obtained, samples should be diluted and re-run.) |
| Interference | No interference from tested substances at specified concentrations (Bilirubin, Triglyceride, Hemoglobin, Protein (Albumin), Imipenem, Cefotaxim, Vancomycin, Dopamine, Noradrenaline, Dobutamine, Heparin, Furosemide, Calcitonin, Katacalcin, a-CGRP, β-CGRP, Calcitonin Salmon, Calcitonin Eel). |
| Clinical Interpretation (PCT > 2.0 ng/ml) | Represents a high risk for progression to severe sepsis and/or septic shock on the first day of ICU admission. |
| Clinical Interpretation (PCT |
§ 866.3210 Endotoxin assay.
(a)
Identification. An endotoxin assay is a device that uses serological techniques in whole blood. The device is intended for use in conjunction with other laboratory findings and clinical assessment of the patient to aid in the risk assessment of critically ill patients for progression to severe sepsis.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance entitled “Class II Special Controls Guidance Document: Endotoxin Assay.” See § 866.1(e) for the availability of this guidance document.