(28 days)
The i-STAT Activated Partial Thromboplastin (aPTT), Prothrombine Time (PT), and Activated Clotting Time (ACT) Controls are intended to be used with the i-STAT portable Clinical Analyzer and i-STAT aPTT, PT, and ACT test cartridges to provide a method for verifying the integrity of newly received cartridges.
The controls produce clotting times within normal ranges and abnormal ranges to indicate that the test cartridges are functioning properly.
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This document is a 510(k) clearance letter from the FDA for the i-STAT Coagulation Control Set. It does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a new diagnostic or AI-powered device.
This clearance is based on substantial equivalence to a predicate device, meaning the new device is as safe and effective as another legally marketed device. The letter primarily confirms that the device can be marketed based on this determination.
Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, and MRMC studies are not applicable to the information provided in this regulatory document.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the intended use of the controls as "to provide a method for verifying the integrity of newly received cartridges" and states that "The controls produce clotting times within normal ranges and abnormal ranges to indicate that the test cartridges are functioning properly."
While a formal table of acceptance criteria with specific threshold values (e.g., +/- 10% of expected value) is not provided in this FDA letter, the implied acceptance criteria are that the i-STAT Coagulation Control Set, when used with i-STAT aPTT, PT, and ACT test cartridges, produces:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Produces clotting times within normal ranges. | The controls do produce clotting times within normal ranges (as verified by the substantial equivalence determination). |
| Produces clotting times within abnormal ranges. | The controls do produce clotting times within abnormal ranges (as verified by the substantial equivalence determination). |
| Indicative of proper functioning of test cartridges. | The controls do indicate that test cartridges are functioning properly (as verified by the substantial equivalence determination). |
| Equivalent in safety and effectiveness to a legally marketed predicate device. | The device is substantially equivalent to a predicate device (FDA's finding). |
2. Sample size used for the test set and the data provenance: Not applicable to this type of regulatory submission. The FDA relies on the manufacturer's data demonstrating substantial equivalence, which would include internal testing, but the details of such testing (like sample size for a "test set" in the context of an AI/diagnostic algorithm) are not explicitly in this letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to coagulation control solutions, not an AI or diagnostic algorithm requiring expert ground truth for image or data interpretation.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No. This is not relevant for a coagulation control set.
6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a control solution for an analyzer, not a standalone algorithm.
7. The type of ground truth used: For a control solution, the "ground truth" would be the known, expected values or ranges of the clotting parameters being measured, established through analytical methods and possibly reference laboratories. This is not explicitly stated but is the inherent nature of a control.
8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
§ 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.