(203 days)
Biophen Low Molecular Weight Heparin (LMWH), Low Molecular Weight Heparin Low (LMWH Low) and Unfractionated Heparin (UFH) control are set of control plasmas for the quality control of Low Molecular weight Heparin(LMWH) and Unfractionated Heparin(UFH) measurements using anti Xa colorimetric assays (Biophen Heparin 3 & 6) . These control plasmas are within the usual therapeutic range recommended for the low molecular weight heparin (LMWH) and Unfractionated Heparin (UFH).
Biophen Heparin & Unfractionated heparin (UFH) Calibrators are set of calibration plasmas for the calibration of Low molecular weight heparin (LMWH) and Unfractionated heparin, using anti-Xa colorimetric assays.
Biophen LMWH, LMWH Low and UFH Control Plasma is an in vitro diagnostic quality control intended for use with chromogenic assays to assess precision and accuracy at Heparin low and high levels (in the usual recommended therapeutic range).
Biophen Heparin Calibrator is a set of calibration plasmas for Heparin (UFH and LMWH) measurements, using anti-Xa colorimetric assays (BIOPHEN HEPARIN 3 and 6). Biophen Heparin Calibrator allows calibrating the assays of Low Molecular Weight Heparin (LMWH) using chromogenic anti-Xa methods. It can be also used for calibrating the measurements of Unfractionated Heparin (UFH) when the BIOPHEN Heparin kit is used. Biophen heparin is a chromogenic anti-Xa method developed for measuring homogeneously heparin (UFH) and Low Molecular Weight Heparin (LMWH), using the same calibration curve.
BIOPHEN UFH Calibrator is a set of calibration plasmas for Unfractionated Heparin (UFH) measurements, using anti-Xa colorimetric assays (BIOPHEN HEPARIN 3 and 6). BIOPHEN UFH Calibrator allows calibrating the measurements of Unfractionated Heparin (UFH) when the BIOPHEN Heparin kit is used.
The provided text describes two separate devices: "Biophen LMWH and UFH Control Plasma" and "Biophen Heparin Calibrator/Biophen UFH Calibrator." I will address the acceptance criteria and study information for each.
Device 1: Biophen LMWH and UFH Control Plasma
This device is an in vitro diagnostic quality control intended for use with chromogenic assays to assess precision and accuracy at Heparin low and high levels in the usual recommended therapeutic range.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device is "substantially equivalent in performance" to its predicate devices. The performance data provided focuses on reproducibility. The acceptance criteria are defined by the "Acceptable Range" within which the measured concentration of LMWH or UFH should fall. The device performance is indicated by the reported LMWH/UFH Concentration and the Standard Deviation (SD).
| Biophen LMWH Control | LMWH Concentration (IU/ml) | Acceptable Range (IU/ml) | N | SD |
|---|---|---|---|---|
| Level 3 | 0.79 | 0.69 - 0.89 | 69 | 0.03 |
| Level 4 | 1.25 | 1.10 - 1.40 | 69 | 0.05 |
| Biophen LMWH Control Low | LMWH Low Concentration (IU/ml) | Acceptable Range (IU/ml) | N | SD |
|---|---|---|---|---|
| Level I | 0.25 | 0.17 - 0.33 | 43 | 0.02 |
| Level II | 0.50 | 0.40 - 0.60 | 43 | 0.03 |
| Biophen UFH Control | UFH Concentration (IU/ml) | Acceptable Range (IU/ml) | N | SD |
|---|---|---|---|---|
| Level 1 | 0.21 | 0.11 - 0.31 | 30 | 0.01 |
| Level 2 | 0.51 | 0.36 - 0.66 | 30 | 0.02 |
2. Sample size used for the test set and the data provenance:
- Sample sizes (N):
- Biophen LMWH Control (Level 3 & 4): 69 samples each
- Biophen LMWH Control Low (Level I & II): 43 samples each
- Biophen UFH Control (Level 1 & 2): 30 samples each
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Hyphen BioMed is based in France.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a quality control plasma, and the "ground truth" (target concentration and acceptable range) is established by the manufacturer through multiple determinations and validated through reproducibility studies, not by clinical experts in the same way imaging or diagnostic studies requiring expert review would.
4. Adjudication method for the test set:
Not applicable. The performance is based on quantitative measurements and statistical analysis (mean, standard deviation), not subjective expert judgment requiring adjudication.
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:
Not applicable. This is an in vitro diagnostic quality control plasma, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not Applicable. This is an in vitro diagnostic quality control plasma.
7. The type of ground truth used:
The ground truth used is the target concentration of LMWH or UFH, established by the manufacturer through multiple determinations (implied by the reporting of mean concentrations and standard deviations). The "Acceptable Range" serves as the clinical or analytical tolerance around this ground truth.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device; therefore, there is no "training set" in the context of machine learning. The "N" values in the table refer to the number of measurements taken for the reproducibility study.
9. How the ground truth for the training set was established:
Not applicable.
Device 2: Biophen Heparin Calibrator & Biophen UFH Calibrator
This device is a set of calibration plasmas for Heparin (UFH and LMWH) measurements, using anti-Xa colorimetric assays. Its intended use is to calibrate assays for LMWH and UFH.
1. Table of Acceptance Criteria and Reported Device Performance:
Similar to the control plasma, the "ground truth" for the calibrators is their established concentration. The performance is assessed by reproducibility, specifically Intra-Assay and Inter-Assay %CV (Coefficient of Variation) or SD. The acceptance criteria are implicitly that the CV/SD values demonstrate "good reproducibility" as stated in the summary.
Biophen Heparin Calibrator (LMWH)
| Calibrator | Concentration in LMWH (IU/ml) | Intra Assay N | Intra Assay CV | Inter Assay N | Inter Assay SD |
|---|---|---|---|---|---|
| Calibrator 1 | 0 | 10 | NA | 50 | 0.01 |
| Calibrator 2 | 0.38 | 10 | 2.3 | 50 | 0.02 |
| Calibrator 3 | 0.77 | 10 | 0.5 | 50 | 0.03 |
| Calibrator 4 | 1.14 | 10 | 1.0 | 50 | 0.05 |
| Calibrator 5 | 1.5 | 10 | 0.5 | 50 | 0.06 |
Biophen UFH Calibrator (Unfractionated Heparin)
| Calibrator | Concentration in Unfractionated Heparin (IU/ml) | Intra Assay N | Intra Assay CV | Inter Assay N | Inter Assay SD |
|---|---|---|---|---|---|
| Calibrator 1 | 0 | 10 | NA | 28 | 0 |
| Calibrator 2 | 0.36 | 10 | 1.4 | 28 | 0.02 |
| Calibrator 3 | 0.74 | 10 | 1.0 | 28 | 0.04 |
| Calibrator 4 | 1.08 | 10 | 0.5 | 28 | 0.06 |
| Calibrator 5 | 1.42 | 10 | 0.5 | 28 | 0.08 |
2. Sample size used for the test set and the data provenance:
- Sample sizes (N): The tables provide the number of measurements for "Intra Assay" (N=10 for all levels) and "Inter Assay" (N=50 for LMWH calibrators, N=28 for UFH calibrators).
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Hyphen BioMed is based in France.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Similar to the control plasma, the "ground truth" (concentration) is established by the manufacturer through multiple determinations and validated through reproducibility studies.
4. Adjudication method for the test set:
Not applicable. Performance is based on quantitative measurements and statistical analysis (CV, SD).
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:
Not applicable. This is an in vitro diagnostic calibrator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used:
The ground truth used is the target concentration of LMWH or UFH in the calibrator plasma, determined by the manufacturer from "multiple determinations."
8. The sample size for the training set:
Not applicable. This is not an AI/ML device; therefore, there is no "training set." The "N" values in the table refer to the number of measurements taken for the reproducibility study.
9. How the ground truth for the training set was established:
Not applicable. The document states that "The concentration of the calibrators is determined from the multiple determinations." This is how the ground truth for these calibrators was established.
§ 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.