(212 days)
Cryo✓Check™ PNP Platelet Lysate is intended for use in the Platelet Neutralization Procedure (PNP) which is useful in detecting the presence of lupus anticoagulants (LA) in human plasma.
Cryo Check™ PNP Platelet Lysate is prepared from human platelets obtained from normal healthy donors. The platelets are collected, washed, and resuspended in buffer and then frozen and thawed to yield a suspension of ruptured platelet membranes. This suspension is aliquoted into cryovials and stored frozen.
The provided text describes the performance of the Cryo✓Check™ PNP Platelet Lysate, but it does not explicitly state acceptance criteria in a formal, quantifiable manner. Instead, the conclusions of the non-clinical performance data serve as the de facto acceptance criteria, implying that the device's performance should be "comparable," "consistent," and "stable" to that of the predicate device or under various conditions.
Here's an attempt to structure the information based on the provided text, interpreting the conclusions as the performance goals the device met:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Conclusions) | Reported Device Performance |
|---|---|
| Criterion 1: Comparable Specificity to Predicate Device for Normal and Lupus Anticoagulant Positive Patient Samples | |
| (Implicit: Results for normal samples should show minimal correction, and results for lupus samples should show significant, comparable correction to the predicate device.) | Compared to BIO/DATA Platelet Extract Reagent (Predicate Device): |
| Normal Plasmas (n=5): | |
| Cryo✓Check™ PNP Platelet Lysate Mean Correction: 0.34 sec | |
| BIO/DATA Platelet Extract Mean Correction: -0.6 sec | |
| Correlation Coefficient: -0.510 (attributed to short correction times, not defect) |
Lupus Plasmas (n=10):
Cryo✓Check™ PNP Platelet Lysate Mean Correction: 15.72 sec
BIO/DATA Platelet Extract Mean Correction: 14.56 sec
Correlation Coefficient: 0.987
Conclusion: "Cryo✓Check™ PNP Platelet Lysate demonstrated comparable specificity to the predicate device when tested against normal plasma and lupus anticoagulant positive patient plasmas when used in a platelet neutralization procedure." |
| Criterion 2: Consistent Vial-to-Vial Reactivity Over 8-hour Period
(Implicit: Low variability in correction times for both normal and lupus plasmas across multiple vials over 8 hours.) | 8 Hour Open Vial Stability Study (MLA 900 C Analyzer):
Normal Plasma (5 vials):
Mean Correction (Time=0 hrs): 4.7 sec (SD 0.292)
Mean Correction (Time=8 hrs): 3.84 sec (SD 0.358)
Lupus Plasma (5 vials):
Mean Correction (Time=0 hrs): 12.6 sec (SD 1.39)
Mean Correction (Time=8 hrs): 11.0 sec (SD 0.358)
Conclusion: "PNP procedures using Cryo✓Check™ PNP Platelet Lysate exhibited consistent vial to vial reactivity over an 8-hour period." |
| Criterion 3: Stability on Automated Coagulation Analyzer for Greater Than 8 Hours
(Implicit: Neutralization results should remain consistent over at least 8 hours when run on an automated analyzer.) | 14 Hour On-Board Stability Study (MDA 180 Analyzer):
Normal Control (CCN-10):
Neutralization (0 min): -4.6 sec
Neutralization (8 hr): -4.4 sec
Neutralization (14 hr): -3.9 sec
Mean Neutralization (0-14 hr): -4.14 sec (Std. Dev. 0.291)
Lupus Positive Control (CCLP-10):
Neutralization (0 min): 17.3 sec
Neutralization (8 hr): 17.5 sec
Neutralization (14 hr): 18.9 sec
Mean Neutralization (0-14 hr): 17.2 sec (Std. Dev. 0.819)
"in-house" positive control (HRF):
Neutralization (0 min): 28.3 sec
Neutralization (8 hr): 29.9 sec
Neutralization (14 hr): 31.2 sec
Mean Neutralization (0-14 hr): 29.8 sec (Std. Dev. 1.055)
Conclusion: "Cryo✓Check™ PNP Platelet Lysate is stable for greater than 8 hours on an MDA 180 automated coagulation analyzer." |
| Criterion 4: Consistent Results Across Different Automated Coagulation Systems
(Implicit: Neutralization results for normal patient samples should be comparable, even if absolute values differ, between different types of coagulation analyzers.) | Comparison of Reactivity on 2 Automated Coagulation Analyzers (25 Normal Patient Samples):
MDA 180 (Photo-Optical Clot Detection): Mean neutralization: -2.084 sec (Std dev 1.051)
Stago ST4 (Mechanical Clot Detection): Mean neutralization: -3.664 sec (Std dev 1.151)
Conclusion: "Cryo✓Check™ PNP Platelet Lysate yielded consistent results when used on 2 different automated coagulation systems." (Note: While mean values differ, the 'consistency' likely refers to the overall behavior and relative neutrality shown for normal samples on both systems.) |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Test 1 (PNP Comparison to Predicate Device):
- Sample Size: 5 normal plasma samples, 10 lupus plasma samples.
- Data Provenance: Not explicitly stated, but clinical samples are implied ("normal and known lupus anticoagulant positive patient samples"). Likely in vitro/laboratory-based.
-
Test 2 (8 Hour Open Vial Stability):
- Sample Size: 5 vials of Cryo✓Check™ PNP Platelet Lysate paired with one "Normal Plasma: Cryo✓Check™ Normal (CCN)" and one "Lupus Plasma: Cryo✓Check™ Lupus (CCLP)".
- Data Provenance: In vitro, using commercially available control plasmas.
-
Test 3 (14 Hour On-Board Stability):
- Sample Size: One lot of Cryo✓Check™ PNP Platelet Lysate tested with three control plasmas (Normal, Lupus Positive, HRF "in-house" positive control) over 14 time points.
- Data Provenance: In vitro, using commercially available and "in-house" control plasmas.
-
Test 4 (Coagulation Analyzer Comparison):
- Sample Size: 25 normal patient samples.
- Data Provenance: Not explicitly stated, but "Normal Patient Samples" implies retrospective or prospective collection from patients. Likely from Canada, given the submitter's location.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a diagnostic reagent, and the 'ground truth' in these studies is established by the clinical classification of the plasma samples (normal vs. lupus anticoagulant positive) and measurement against established laboratory methods (APTT, Platelet Neutralization Procedure). No human expert interpretation of images or other subjective data is involved. The ground truth for plasma samples (e.g., "Lupus Plasma") would have been established through prior diagnostic testing, but the details of those classifications are not provided.
4. Adjudication Method for the Test Set
Not applicable. As this involves laboratory measurements with quantitative outputs (seconds for APTT and correction), not subjective interpretation, an adjudication method for a test set is not relevant in the way it would be for, e.g., image analysis by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret cases with or without AI assistance. The described studies are non-clinical performance evaluations of a laboratory reagent.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described are standalone performance evaluations in the context of a laboratory reagent. The device (Cryo✓Check™ PNP Platelet Lysate) is evaluated on its own performance characteristics (specificity, stability, consistency) in conjunction with standard laboratory instruments and established protocols (PNP, APTT). There is no "human-in-the-loop" AI component.
7. The Type of Ground Truth Used
The ground truth used for these studies is clinical classification of patient plasma samples (normal vs. known lupus anticoagulant positive) and established laboratory methods (specifically, the Platelet Neutralization Procedure (PNP) and Activated Partial Thromboplastin Time (APTT) measurements). For the stability and analyzer comparison studies, commercially available control plasmas and patient samples classified as "normal" or "lupus positive" served as the reference.
8. The Sample Size for the Training Set
Not applicable. This device is a laboratory reagent; there is no mention of an algorithm or AI that would require a "training set." The studies performed are validation studies for the performance characteristics of the physical reagent.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).