(65 days)
HemosIL LA Positive Control is intended for use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL dRVVT Screen/dRVVT Confirm, HemosIL LAC Screen/LAC Confirm and HemosIL Silica Clotting Time Screen and Confirm) on IL Coagulation systems [ACL TOP] Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
HemosIL LA Negative Control is intended for use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL dRVVT Screen/dRVVT Confirm, HemosIL LAC Screen/LAC Confirm and HemosIL Silica Clotting Time Screen and Confirm) on IL Coagulation systems [ACL TOP Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
HemosIL LA Negative Control is a lyophilized preparation using human citrated platelet-poor plasma to make a pooled normal plasma with added buffer. The device consists of ten 1-ml vials of lyophilized controls per package.
HemosIL LA Positive Control is a lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies with added buffer. The device consists of ten 1-ml vials of lyophilized controls per package.
The provided text describes a 510(k) premarket notification for the HemosIL LA Positive Control & HemosIL LA Negative Control, primarily focusing on establishing a new reconstituted frozen stability claim. The submission aims to demonstrate substantial equivalence to a previously cleared device (K110031) with this added claim.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Reconstituted Frozen Stability: 3 weeks at -20°C in its closed original vial. | The applicant has a reconstituted stability of 3 weeks at -20°C in its closed original vial. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a test set used to prove the new stability claim. It also does not specify the provenance of any data used for this specific stability study (e.g., country of origin, retrospective or prospective).
The submission focuses on a new stability claim for existing controls, implying that tests would have been performed to validate this. However, the details of these tests (such as the number of control vials tested, the number of measurements taken, or the specific experimental design) are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. For a quality control product like this, "ground truth" typically refers to the confirmed stability characteristics and performance of the control. The establishment of such ground truth would typically be done through controlled laboratory studies and adherence to established quality control guidelines, rather than by expert consensus in the way clinical diagnostic devices might.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a quality control product and the type of performance characteristic being evaluated (stability), an adjudication method in the context of expert review or consensus, such as 2+1 or 3+1, is unlikely to be relevant or applicable. Performance would be assessed against predefined analytical specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable and not provided. The device is a quality control material for in vitro coagulation studies, not an AI-assisted diagnostic tool or an imaging device that involves human reader interpretation. Therefore, an MRMC study or a comparison of human reader performance with and without AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. The device is a laboratory control, not an algorithm. Its performance is evaluated analytically, not as a standalone algorithm.
7. The Type of Ground Truth Used
For the specific new claim being made (reconstituted frozen stability), the "ground truth" would be established through analytical testing and measurements of the control's performance over the specified stability period (3 weeks at -20°C). This would involve measuring the control's activity or characteristics using the target LA assays and instruments, and demonstrating that these measurements remain within pre-defined acceptable ranges throughout the claimed stability period. The document refers to "Performance Characteristics M. Analytical performance" and "c. Traceability, Stability, Expected values (controls, calibrators, or methods)" as sections where these details would typically be found, stating "Reconstituted Frozen Stability: 3 weeks at -20°C in its closed original vial."
8. The Sample Size for the Training Set
This information is not provided. As a quality control product, the concept of a "training set" in the context of machine learning algorithms is not applicable here. The development and manufacturing of the control would involve process validation and extensive quality control testing, but not a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the reasons stated in 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.