CryoCheck Weak Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.
Device Story
CryoCheck Weak Positive Control; human source plasma-derived control; frozen format. Used in clinical laboratory settings to verify performance of lupus anticoagulant assays. Provides weak positive signal to monitor assay sensitivity; ensures quality control for coagulation testing. Clinicians/technicians use output to validate assay results; ensures accurate detection of lupus anticoagulant in patient samples.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Human source plasma; frozen liquid control; standalone diagnostic reagent. No software or electronic components.
Indications for Use
Indicated for use as a positive control in laboratory assays for lupus anticoagulant using human source plasma.
Regulatory Classification
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.
Special Controls
*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.
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
K032804
B. Analyte:
Lupus
C. Type of Test:
Control
D. Applicant:
Precision BioLogic
E. Proprietary and Established Names:
CryoCheck Weak Positive Control
F. Regulatory Information:
1. Regulation section:
21 CFR 864.5425
2. Classification:
Class II
3. Product Code:
GGC
4. Panel:
81 Hematology
G. Intended Use:
1. Indication(s) for use:
CryoCheck Weak Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.
2. Special condition for use statement(s):
3. Special instrument Requirements:
H. Device Description:
I. Substantial Equivalence Information:
1. Predicate device name(s):
CryoCheck Positive Control
2. Predicate K number(s):
K952623
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3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Material | Human source | Same |
| Intended Use | Use as a positive control in assays for lupus anticoagulant | Same |
| Format | Frozen | Same |
| Differences | | |
| Item | Device | Predicate |
| Potency | Weak Positive | Strong Positive |
J. Standard/Guidance Document Referenced (if applicable):
K. Test Principle:
L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Intra-Vial Precision (%CV)
PT - 0.55% APTT - 0.62%
b. Linearity/assay reportable range:
c. Traceability (controls, calibrators, or method):
d. Detection limit:
e. Analytical specificity:
f. Assay cut-off:
2. Comparison studies:
a. Method comparison with predicate device:
b. Matrix comparison:
3. Clinical studies:
a. Clinical sensitivity:
b. Clinical specificity:
c. Other clinical supportive data (when a and b are not applicable):
4. Clinical cut-off:
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5. Expected values/Reference range:
M. Conclusion:
Based on a review of the precision data, and device labeling I recommended that this device is found substantially equivalent to a legally marketed device.
