(47 days)
i-STAT® Activated Clotting Time (ACT) Control is used to verify the integrity of newly received i-STAT® Activated Clotting Time cartridges.
This is a lyophilized product prepared from human plasma, with added purified I mo to a ly ophilizes. The control is provided in lyophilized form for increased stability.
The provided document describes the Bio-Rad Laboratories i-STAT Activated Clotting Time (ACT) Control Set, a device used to verify the integrity of newly received i-STAT ACT cartridges. This is a 510(k) premarket notification, which means the device claims substantial equivalence to a legally marketed predicate device (i-STAT Coagulation Control Set, K981752), rather than undergoing a de novo clinical trial to prove efficacy.
Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a new device would. Instead, the "study" referred to here is a comparison to a predicate device and stability studies.
Here's a breakdown of the requested information based on the provided text, with many points indicating that the information is "Not Applicable" or "Not Provided" due to the nature of a 510(k) submission for a control set:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document implies that the primary acceptance criterion is that the new device performs similarly enough to the predicate device to be considered substantially equivalent for its intended use. For an IVD control, this typically means:
- Intended Use: Identical.
- Matrix: Identical.
- Form: Identical.
- Storage (Unopened): Similar (2 to 8°C vs. 2 to 10°C).
- Open Vial Stability: Identical ("Use immediately").
- Shelf Life: Established through stability testing.
Reported Device Performance:
| Characteristic | Accepted (Bio-Rad Laboratories ACT Control Set) | Predicate (BIOPOOL INTL., INC i-STAT Coagulation Control Set) |
|---|---|---|
| Intended Use | Verify integrity of newly received i-STAT ACT cartridges. | Verify integrity of newly received i-STAT ACT cartridges. |
| Matrix | Human plasma | Human plasma |
| Form | Lyophilized | Lyophilized |
| Storage (Unopened) | Refrigerated (2 to 8°C) | Refrigerated (2 to 10°C) |
| Open Vial stability | Use immediately | Use immediately |
| Shelf Life | 18 months at 2 to 8°C (supported by internal stability studies) | Not explicitly stated in comparison, but inherent to predicate's regulatory clearance. |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not provided. The submission refers to "Stability studies" and "All supporting data is retained on file at Bio-Rad Laboratories." This implies internal testing rather than a large clinical test set.
- Data Provenance: Not provided, but given it's a Bio-Rad submission, the data is likely from internal testing by the manufacturer. The document does not specify country of origin or if it's retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. As a control set, its performance is determined by its chemical and biological properties, and its stability over time. It's not a diagnostic device that requires expert interpretation of results to establish a "ground truth" in the diagnostic sense. The ground truth for this device would be its validated chemical properties and stability, confirmed by laboratory testing.
4. Adjudication Method
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This device is a control set, not an AI or diagnostic tool that involves human readers or interpretation of complex cases. Therefore, an MRMC study is not relevant.
6. Standalone Performance Study (Algorithm Only)
- Not Applicable. This is a physical control product, not an algorithm. Its "performance" is its ability to remain stable and provide expected results for verifying other devices.
7. Type of Ground Truth Used
- The "ground truth" for this device would be established through laboratory testing and analytical methods to confirm the composition and stability of the human plasma and other components. Specifically, "Stability studies have been performed to determine shelf life for this control," indicating that these studies form the basis of the performance claims.
8. Sample Size for the Training Set
- Not Applicable. This is a physical control product, not a machine learning algorithm, so there is no "training set."
9. How Ground Truth for Training Set was Established
- Not Applicable. See point 8.
§ 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.