(32 days)
Reference Check is recommended for use in controlling the accuracy of quantitative hemostasis assays Reference Check is recommended for use in controlling the following parameters in the normal range:
- Fibrinogen .
- Factor II .
- Factor V .
- Factor VII .
- Factor VIII:C
- vWF: antigen ●
- vWF: Ristocetin Cofactor ●
- Factor IX ●
- Factor X .
- Factor XI .
- Factor XII .
- Factor XIII ●
- Prekallikrein .
- Protein C: antigen ●
- Protein C: activity ●
- Protein S: activity .
- Protein S: total .
- Protein S: free .
- Antithrombin: activity ●
- Antithrombin: antigen .
- Alpha-2-antiplasmin .
- Plasminogen .
Reference Check is citrated human plasma collected from 20 or more carefully screened normal donors. Plasmas are pooled, buffered using 0.01M HEPES buffer, aliquoted and rapidly frozen.
The provided text focuses on the 510(k) summary for "Reference Check," a normal control plasma, and strongly emphasizes its substantial equivalence to a predicate device, "Control Plasma N (K001256)." The information details the device's characteristics and its intended use for controlling the accuracy of quantitative hemostasis assays. However, it does not contain the specifics of a study proving the device meets acceptance criteria in the manner of a typical AI/ML device submission. Instead, the "study" is an argument for substantial equivalence.
Based on the provided text, here's an attempt to answer your questions, highlighting where information is absent for this type of medical device submission:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device. The performance is described in terms of its characteristics and intended use being similar to the predicate.
| Acceptance Criteria (Implicit from Substantial Equivalence to Predicate) | Reported Device Performance (Reference Check) |
|---|---|
| Intended Use: Assayed Control - Normal | Assayed control for accuracy of quantitative hemostasis assays in the normal range. |
| Analytes Controlled: Fibrinogen, Coagulation factors II, V, VII, VIII, vWF: Antigen, vWF: Ristocetin Cofactor, IX, X, XI, XII, XIII, prekallikrein, Protein C (antigen and activity), Protein S (activity, total and free), antithrombin (antigen and activity), Alpha-2 antiplasmin, plasminogen | Controls Fibrinogen, Factor II, Factor V, Factor VII, Factor VIII:C, vWF: antigen, vWF: Ristocetin Cofactor, Factor IX, Factor X, Factor XI, Factor XII, Factor XIII, Prekallikrein, Protein C: antigen, Protein C: activity, Protein S: activity, Protein S: total, Protein S: free, Antithrombin: activity, Antithrombin: antigen, Alpha-2-antiplasmin, Plasminogen. |
| Matrix: Reagent from human plasma | Citrated human plasma collected from 20 or more carefully screened normal donors, pooled and buffered using 0.01M HEPES buffer. |
| Format: (Predicate is Lyophilized) | Frozen |
| Volume: 1 mL per vial | 1 mL per vial |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. The submission focuses on comparing the characteristics of the Reference Check product to a predicate device rather than presenting a performance study with a test set of data. The device itself is derived from "citrated human plasma collected from 20 or more carefully screened normal donors."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided. As this is a control plasma and not an AI/ML diagnostic device analyzing complex data, the concept of "experts establishing ground truth for a test set" does not directly apply in the usual sense. The "ground truth" for a control plasma is its assigned values for the analytes it controls, which would be established through laboratory methods and standardization.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation (e.g., of medical images) where discrepancies need resolution. This is not applicable to a control plasma product.
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
There was no MRMC study conducted. This type of study is relevant for AI/ML diagnostic tools that assist human readers, which Reference Check is not.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
There was no standalone performance study in the context of an algorithm. Reference Check is a physical laboratory reagent, not an algorithm. Its "standalone" performance would be its stability, consistency, and assigned values, which are inherent to its manufacturing and quality control.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a control plasma would be the assigned values (ranges) for the various analytes (e.g., Fibrinogen, Factor II, Protein C activity) determined through standardized laboratory assays. The document states both products are "assayed and provide reference ranges."
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" in the context of a manufactured control plasma. Its characteristics are determined by the pooled human plasma used in its production.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there's no training set. The "ground truth" (assigned values) for the product is established through rigorous laboratory testing and calibration methods during its manufacture. The device description mentions it is "citrated human plasma collected from 20 or more carefully screened normal donors," indicating the source material for establishing its normal range.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.