(81 days)
- HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the normal range. The product is intended in the assessment of precision and accuracy for PT, APTT and Fibrinogen tests performed on coagulation systems.
- HemosIL Routine Control Level 2 is for the quality control of coagulation assays in the low abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
- HemosIL Routine Control Level 3 is for the quality control of coagulation assays in the high abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
For in vitro diagnostic use.
- The HemosIL Routine Control Level 1 is a lyophilized product prepared using human citrated plasma from healthy donors. It contains buffer, stabilizers and preservatives.
- The HemosIL Routine Control Level 2 is a lyophilized product prepared using human citrated plasma from healthy donors (not heparinized plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to stimulate an abnormal coagulation sample. It contains buffer and stabilizers. No preservatives are included.
- The HemosIL Routine Control Level 3 is a lyophilized product prepared using human citrated plasma from healthy donors (not heparinized plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to stimulate an abnormal coagulation sample. It contains buffer and stabilizers. No preservatives are included.
The provided document describes the "HemosIL Routine Control Levels 1, 2, and 3" which are medical devices intended for quality control of coagulation assays. This is not an AI/ML powered device, therefore, many of the requested criteria such as "Adjudication method," "MRMC comparative effectiveness study," and "Standalone (algorithm only) performance" are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for the device, but it presents precision data as the primary performance characteristic to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the device's precision (measured by Within-Run %CV) is comparable to or better than established or acceptable values for coagulation controls.
| HemosIL Routine Control Level | Analyte | Reagent | Instrument | Mean | Reported Device Performance (Within-Run %CV) |
|---|---|---|---|---|---|
| Level 1 | Prothrombin Time (PT) | HemosIL PT-Fibrinogen Recombinant (K981479) | ACL 9000 | 9.9 seconds | 2.27 |
| HemosIL PT-Fibrinogen (K862301) | ACL Advance | 11.5 seconds | 1.48 | ||
| HemosIL PT-Fibrinogen HS Plus (K060931) | ACL 300 | 13.4 seconds | 1.46 | ||
| Fibrinogen | HemosIL PT-Fibrinogen Recombinant (K981479) | ACL 6000 | 270.9 mg/dL | 3.91 | |
| HemosIL PT-Fibrinogen (K862301) | ACL Advance | 319.0 mg/dL | 3.13 | ||
| HemosIL PT-Fibrinogen HS Plus (K060931) | ACL 300 | 283.4 mg/dL | 4.41 | ||
| Activated Partial | HemosIL APTT-SP (K973306) | ACL 9000 | 28.7 seconds | 0.98 | |
| Thromboplastin (APTT) | HemosIL SynthAFax (K955638) | ACL 6000 | 20.5 seconds | 0.91 | |
| HemosIL SynthASil (K060688) | ACL Advance | 30.1 seconds | 1.15 | ||
| Level 2 | Prothrombin Time (PT) | HemosIL PT-Fibrinogen Recombinant (K981479) | ACL 9000 | 27.2 seconds | 2.49 |
| HemosIL PT-Fibrinogen (K862301) | ACL Advance | 22.6 seconds | 1.24 | ||
| HemosIL PT-Fibrinogen HS Plus (K060931) | ACL 300 | 41.3 seconds | 1.56 | ||
| Activated Partial | HemosIL APTT-SP (K973306) | ACL 9000 | 47.9 seconds | 1.69 | |
| Thromboplastin (APTT) | HemosIL SynthAFax (K955638) | ACL 6000 | 40.9 seconds | 1.26 | |
| HemosIL SynthASil (K060688) | ACL Advance | 47.2 seconds | 1.26 | ||
| Level 3 | Prothrombin Time (PT) | HemosIL PT-Fibrinogen Recombinant (K981479) | ACL 9000 | 37.0 seconds | 2.65 |
| HemosIL PT-Fibrinogen (K862301) | ACL Advance | 31.4 seconds | 2.61 | ||
| HemosIL PT-Fibrinogen HS Plus (K060931) | ACL 300 | 63.5 seconds | 1.40 | ||
| Activated Partial | HemosIL APTT-SP (K973306) | ACL 9000 | 60.7 seconds | 0.62 | |
| Thromboplastin (APTT) | HemosIL SynthAFax (K955638) | ACL 6000 | 55.4 seconds | 1.98 | |
| Thromboplastin (APTT) | HemosIL SynthASil (K060688) | ACL Advance | 56.3 seconds | 1.14 |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: For each combination of control level, analyte, reagent, and instrument, the "Mean (n=80)" indicates that 80 measurements were performed to assess within-run precision.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Instrumentation Laboratory Co. is based in Lexington, MA, USA, it's likely the studies were conducted within the US. The nature of precision studies for quality controls usually implies prospective testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This device is a quality control material for laboratory tests, not a diagnostic device that requires expert interpretation of images or patient data to establish ground truth. The "truth" or target values for these controls are established through scientific measurement and statistical analysis against reference methods and materials, not expert consensus.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, this is not a diagnostic device involving expert interpretation or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. This is not an AI-powered diagnostic tool, and therefore, no MRMC study comparing human readers with and without AI assistance was performed.
6. Standalone (Algorithm Only) Performance:
- Not Applicable. This is a physical control material, not an algorithm, so standalone performance is not relevant.
7. Type of Ground Truth Used:
- The "ground truth" for the HemosIL Routine Controls is established by analytical measurement against reference methods and materials, and characterized by its mean value and precision (within-run %CV). This is a form of analytical performance data, not clinical outcomes or expert consensus. The controls are designed to mimic human plasma, and their performance is evaluated based on their stability and reproducibility on various coagulation systems.
8. Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a "training set." The product's characteristics are determined through manufacturing processes and analytical testing.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
§ 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.