CRYOCHECK WEAK LUPUS POSITIVE CONTROL

K032804 · Precision Biologic · GGC · Nov 3, 2003 · Hematology

Device Facts

• Record ID: K032804
• Device Name: CRYOCHECK WEAK LUPUS POSITIVE CONTROL
• Applicant: Precision Biologic
• Product Code: GGC · Hematology
• Decision Date: Nov 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications 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.

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.

Predicate Devices

• CryoCheck Positive Control (K952623)

Submission Summary (Full Text)

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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.