(245 days)
Diazyme PCT Assay is a latex particle enhanced immunoturbidimetric method for the quantitative determination of PCT in human serum, EDTA or lithium heparin plasma. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock. For in vitro diagnostic use only.
The Diazyme PCT Calibrator Set is intended for use in the Diazyme PCT Assay. For in vitro diagnostic use only.
The Diazyme PCT Control Set is intended for use as quality control for the Diazyme PCT Assay. For in vitro diagnostic use only.
Diazyme PCT Assay is a latex particle enhanced immunoturbidimetric method for the quantitative determination of PCT in human serum, EDTA or lithium heparin plasma.
This document is a 510(k) premarket notification acceptance letter from the FDA for a Diazyme Procalcitonin (PCT) Assay system. It confirms that the device is substantially equivalent to a predicate device for aiding in the risk assessment of critically ill patients for progression to severe sepsis and septic shock.
The provided document DOES NOT CONTAIN the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which includes performance data, analytical and clinical studies, and the establishment of ground truth. The letter only acknowledges the acceptance of the submission and states the device is substantially equivalent.
Therefore, I cannot provide the specific details for the following points based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not in the acceptance letter.
- Sample sizes used for the test set and the data provenance: Not in the acceptance letter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not in the acceptance letter.
- Adjudication method for the test set: Not in the acceptance letter.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a diagnostic assay (in-vitro diagnostic), not an AI image analysis tool. Therefore, an MRMC study is not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As this is an in-vitro diagnostic assay, "standalone performance" refers to the assay's performance characteristics (e.g., analytical sensitivity, specificity, precision, accuracy), which are not detailed here. It's not an "algorithm" in the sense of AI.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While the indication for use mentions "other laboratory findings and clinical assessments," the specific ground truth methodology for the study is not stated. For a PCT assay, ground truth would typically involve clinical diagnosis of sepsis/septic shock based on established criteria (e.g., Sepsis-3 definitions), potentially including microbiology, inflammatory markers, and patient outcomes.
- The sample size for the training set: Not in the acceptance letter.
- How the ground truth for the training set was established: Not in the acceptance letter.
To fully answer your request, you would need access to the actual 510(k) submission document for K162297, which contains the detailed study reports.
§ 866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
(a)
Identification. A device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis is identified as an in vitro device intended for the detection and qualitative and/or quantitative measurement of one or more non-microbial analytes in human clinical specimens to aid in the assessment of patients with suspected sepsis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the device's detailed Indications for Use statement describing what the device detects and measures, the results provided to the user, whether the measure is qualitative and/or quantitative, the clinical indications for which the test is to be used, and the specific population(s) for which the device use is intended.
(2) Premarket notification submissions must include detailed documentation of the device description, including (as applicable), all device components, software, ancillary reagents required but not provided, explanation of the device principle and methodology, and for molecular devices include detailed documentation of the primer/probe sequence, design, and rationale for sequence selection.
(3) Premarket notification submissions must include detailed documentation of applicable analytical studies, such as, analytical sensitivity (Limit of Detection, Limit of Blank, and Limit of Quantitation), precision, reproducibility, analytical measuring range, interference, cross-reactivity, and specimen stability.
(4) Premarket notification submissions must include detailed documentation of a prospective clinical study or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information:
(i) Results must demonstrate adequate device performance relative to a well-accepted comparator.
(ii) Clinical sample results must demonstrate consistency of device output throughout the device measuring range likely to be encountered in the Intended Use population.
(iii) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the Indications for Use(s), and results of all statistical analyses.
(5) Premarket notification submissions must include evaluation of the level of the non-microbial analyte in asymptomatic patients with demographic characteristics (
e.g., age, racial, ethnic, and gender distribution) similar to the Intended Use population.(6) As part of the risk management activities performed under 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.
(7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling, and a detailed explanation of the interpretation of the limitations of the samples (
e.g., collected on day of diagnosis) must be included in the device's 21 CFR 809.10(b)(10) compliant labeling.