CONTROL PLASMA N, PROC CONTROL PLASMA

K042333 · Dade Behring, Inc. · GGN · Dec 1, 2004 · Hematology

Device Facts

• Record ID: K042333
• Device Name: CONTROL PLASMA N, PROC CONTROL PLASMA
• Applicant: Dade Behring, Inc.
• Product Code: GGN · Hematology
• Decision Date: Dec 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

The Control Plasma N is an assayed control used to monitor the performance of the following parameters in the normal range: Prothrombin time (PT), Activated partial thromboplastin time (APTT), Thrombin Time (TT), Bastroxobin time, Fibrinogen, Coagulation Factors II, V, VII, VIII, vWF, IX, X, XI, XII, inhibitors: Antithrombin III, protein C, protein S, α2-antiplasin, Plasminogen, Lupus anticoagulants and Factor V Leiden. The ProC® Control Plasma is an assayed control intended to monitor the performance of Factor V Leiden assay in the pathological range.

Device Story

Lyophilized plasma controls; Control Plasma N (pooled human plasma, HEPES buffer); ProC® Control Plasma (pooled human and rabbit plasma, HEPES buffer). Used in clinical laboratories to monitor coagulation assay performance; ensures accuracy of test results for PT, APTT, and various coagulation factors. Reconstituted by laboratory personnel; stability validated for 4 hours at 15-25°C or 4 weeks at -20°C. Provides quality control metrics for healthcare providers to verify instrument/reagent system performance; supports clinical decision-making by ensuring reliable diagnostic data for coagulation disorders.

Clinical Evidence

No clinical studies performed. Analytical performance verified via real-time stability studies (4 hours at 15-25°C, 8 hours at 2-8°C, 4 weeks at -20°C). Factor V Leiden sensitivity for ProC® Control Plasma verified using 42 specimens from previously diagnosed Factor V Leiden deficient individuals; control material recovered within expected ranges.

Technological Characteristics

Lyophilized, stabilized pooled human plasma. ProC® Control Plasma includes rabbit plasma to adjust sensitivity for Factor V Leiden. Stabilized with HEPES buffer. Compatible with mechanical and photo-optical coagulation analyzers. No specific ASTM standards cited.

Indications for Use

Indicated for use as quality control material for coagulation assays in clinical laboratory settings. Control Plasma N monitors normal range performance for PT, APTT, TT, Bastroxobin time, Fibrinogen, coagulation factors, and inhibitors. ProC® Control Plasma monitors Factor V Leiden assay performance in the pathological range.

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

• Control Plasma N (K023309)
• Chromogenix Control Plasma Level 2 (K963111)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
K042333

B. Purpose for Submission:
To seek the clearance of a new device, and the modification of a currently cleared device.

C. Measurand:
The ProC® Control Plasma controls the Factor V Leiden assay. The Control Plasma N controls for the Prothrombin time (PT), Activated partial thromboplastin time (APTT), Thrombin Time (TT), Baxtroxobin time, Fibrinogen, Coagulation Factors II, V, VII, VIII, vWF, IX, X, XI, XII, inhibitors: Antithrombin III, protein C, protein S, $\alpha2$-antiplasin, Plasminogen, Lupus anticoagulants and Factor V Leiden.

D. Type of Test:
Quantitative

E. Applicant:
Dade Behring, INC

F. Proprietary and Established Names:
ProC® Control Plasma
Control Plasma N

G. Regulatory Information:
1. Regulation section:
21 CFR 864.5425 Multipurpose Systems for In Vitro Coagulation Studies

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2. Classification:
Class II

3. Product code:
GGN

4. Panel:
81

H. Intended Use:

1. Intended use(s):
The Control Plasma N is an assayed control used to monitor the performance of the following parameters in the normal range: Prothrombin time (PT), Activated partial thromboplastin time (APTT), Thrombin Time (TT), Bastroxobin time, Fibrinogen, Coagulation Factors II, V, VII, VIII, vWF, IX, X, XI, XII, inhibitors: Antithrombin III, protein C, protein S, α2-antiplasin, Plasminogen, Lupus anticoagulants and Factor V Leiden.

The ProC® Control Plasma is an assayed control intended to monitor the performance of Factor V Leiden assay in the pathological range.

2. Indication(s) for use:
Same

3. Special conditions for use statement(s):
Not Applicable

4. Special instrument requirements:
Not Applicable

I. Device Description:
Control Plasma N is a lyophilized control prepared from pooled human plasma, stabilized with HEPES buffer solution.

The ProC® Control Plasma is a lyophilized control prepared from pooled plasma

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from selected health donors which is adjusted to a defined sensitivity value by the addition of rabbit plasma. Rabbit Factor V, like human Factor V Leiden, is not rapidly degraded by Activated Protein C (APC), thus reducing the coagulation time in APC dependent tests. The control is stabilized with HEPES buffer solution.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Control Plasma N

Chromogenix Control Plasma Level 2

2. Predicate 510(k) number(s):

K023309

K963111

3. Comparison with predicate:

| Similarities- Control Plasma N | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix | Stabilized reagent prepared from pooled human plasma | same |
| Intended Use | To provide quality control in the normal range | same |
| Form | Lyophilized | same |
| Instrumentation | Mechanical and photo-optical | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | PT, APTT, TT, Baxtroxobin time, Fibrinogen, Coagulation Factors II, V, VII, VIII, vWF, IX, X, XI, XII, inhibitors: | All except Factor V Leiden |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Antithrombin III, protein C, protein S, α2-antiplasin, Plasminogen, Lupus anticoagulants and Factor V Leiden. | |
| Similarities- ProC® Control Plasma | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | To monitor the performance of Factor V Leiden assay in the pathological range | same |
| Analyte | Factor V Leiden | same |
| Form | Lyophilized | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix | Pooled plasma from healthy human donors adjusted with rabbit plasma | Citrated human plasma from selected donors |
| Instrumentation | For use on photo-optical coagulation systems | For use on turbidimetric, photometric and electro-mechanical coagulation systems |

# K. Standard/Guidance Document Referenced (if applicable):

Not Applicable

# L. Test Principle:

Not Applicable

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:
Not Applicable

b. Linearity/assay reportable range:
Not Applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Real time stability studies were performed on two lots of control material using at least duplicate determinations. Results were within ± 10% of the initial reconstituted value for the following claims: 4 hours @ 15 to 25°C, 8 hours @ 2 to 8°C, and 4 weeks @ -20°C or below (10 Min thawing @ 37°C), and support a support-life expiration of more than 3 months.

Values for the Factor V Leiden for both the ProC® Control Plasma and Control Plasma N are calculated using the mean of at least 12 single determinations on multiple analyzers with multiple reagent lots. Separate assigned values are reported for Dade Behring BCS® analyzer and Sysmex® CA analyzers (CA-1500 and CA-7000).

Sensitivity of ProC® Control Plasma as a quality control material for Factor V Leiden assay was verified during studies conducted for performance evaluation of Dade Behring Factor V Leiden assay with the BCS® analyzer. In those studies, a total of 42 specimens form individuals who were previously diagnosed as Factor V Leiden deficient were divided and tested in three different runs. For each run, ProC® Control Plasma was tested twice as positive control material. All specimens were found to be positive for Factor V Leiden by the screening reagent and the control recovered within the expected range.

d. Detection limit:
Not Applicable

e. Analytical specificity:
Not Applicable

f. Assay cut-off:

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g. 2. Comparison studies:

a. Method comparison with predicate device:
Not Applicable

b. Matrix comparison:
Not Applicable

3. Clinical studies:

a. Clinical Sensitivity:
Not Applicable

b. Clinical specificity:
Not Applicable

c. Other clinical supportive data (when a. and b. are not applicable):

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Not Applicable

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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