(110 days)
This product permits the quantitative in vitro diagnostic determination of Complement 3 in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. C3 is one of a group of serum proteins which destroy infectious agents. Measurement of this protein aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of C3.
quantex C3: 8 x 6 mL anti-human C3 P/N 3000-22136; 2 x 100 mL Buffer P/N 3000-22130
This document is a 510(k) summary for a medical device called "quantex C3". It describes a device used for quantitative in vitro diagnostic determination of Complement 3 in serum and plasma. The study presented here is a comparative performance study against a predicate device, not a standalone study demonstrating the device meets specific acceptance criteria based on a pre-defined ground truth. Therefore, many of the requested categories (like acceptance criteria, ground truth, expert involvement, and MRMC studies) are not applicable or cannot be extracted from the provided text.
Here is the information that can be extracted, and an explanation for the missing information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Correlation (r) = 0.9842 |
Explanation: The document does not specify pre-defined acceptance criteria for the performance of the quantex C3 device (e.g., a minimum correlation coefficient, accuracy, or precision thresholds). Instead, it presents a comparison study against a predicate device to demonstrate substantial equivalence. The reported device performance is the correlation coefficient between the new device and the predicate.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Fifty serum samples
- Data Provenance: Not explicitly stated (e.g., country of origin, demographics). The study appears to be retrospective as it involved analyzing "fifty serum samples," implying pre-collected samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The study performs a method comparison against a predicate device, not against an independent 'ground truth' established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- None. The study design is a direct comparison between two measurement systems (the new device and the predicate device), not an assessment requiring expert adjudication of results.
5. 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
- No. This is an in vitro diagnostic (IVD) device for measuring a biological marker (Complement 3), not an imaging or diagnostic aid for human readers. Therefore, an MRMC study with human readers is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in the context of an IVD. The performance reported (correlation coefficient) is for the device's analytical measurement capability itself, without direct human interpretation in each measurement. However, it's a comparison to a predicate device, not an absolute standalone performance against a true gold standard.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Predicate Device Measurement. The "ground truth" in this comparative study is effectively the measurements obtained from the predicate device (IL Test™ C3 on a Monarch Clinical Chemistry System). It's a comparison for substantial equivalence, not validation against a true biological ground truth (e.g., patient outcome or a reference laboratory standard).
8. The sample size for the training set
- Not Applicable. This is not a machine learning model; therefore, there is no "training set." This study is a performance evaluation of a device/reagent against another device/reagent.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).