CONTROL PLASMA N AND CONTROL PLASMA P

K042209 · Dade Behring, Inc. · GGN · Oct 21, 2004 · Hematology

Device Facts

• Record ID: K042209
• Device Name: CONTROL PLASMA N AND CONTROL PLASMA P
• Applicant: Dade Behring, Inc.
• Product Code: GGN · Hematology
• Decision Date: Oct 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

Control Plasma N is an assayed control for use in monitoring the performance of the following parameters in the normal range: 1. Prothrombin time (PT) 2. Activated partial thromboplastin time (APTT) 3. Thrombin time (TT) 4. Batroxobin time 5. Fibrinogen 6. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII 7. Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin 8. Plasminogen 9. Lupus anticoagulants. Control Plasma P is an assayed control for use in monitoring the performance of the following parameters in the pathological range: 1. Prothrombin time (PT) 2. Activated partial thromboplastin time (aPTT) 3. Fibrinogen (Clauss method) 4. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII 5. Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin 6. Plasminogen.

Device Story

Control Plasma N and P are lyophilized, human-plasma-derived controls used in clinical laboratories to monitor the performance of coagulation assays. Control Plasma N is pooled human plasma stabilized with HEPES buffer for normal range monitoring; Control Plasma P is pooled human plasma adjusted to defined factor concentrations and stabilized with HEPES for pathological range monitoring. These controls are used by laboratory technicians to verify the accuracy and precision of coagulation testing systems. By comparing observed results against the assayed values provided for the controls, clinicians ensure the reliability of patient test results for parameters including PT, aPTT, fibrinogen, and various coagulation factors. This quality control process helps maintain the integrity of clinical decision-making regarding patient coagulation status.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility evaluated using retrospective data from 68 lots (Control Plasma N) and 54 lots (Control Plasma P). Control Plasma N precision: 2.1–4.5% CV. Control Plasma P precision: 3.0–8.1% CV.

Technological Characteristics

Pooled human plasma; HEPES buffer stabilizer; lyophilized form; siliconized vials. Compatible with mechanical and photo-optical coagulation instrumentation. Traceable to WHO reference preparations and in-house standards.

Indications for Use

Indicated for use as an assayed control to monitor the performance of coagulation assays in normal (Control Plasma N) and pathological (Control Plasma P) ranges for patients undergoing coagulation testing.

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

• Dade Behring Control Plasma N (K023309)
• Dade Behring Control Plasma P (K023312)

Submission Summary (Full Text)

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

A. 510(k) Number: #K042209
B. Purpose for Submission: Bundled 510(k) for device modification
C. Measurand: Multiple coagulation analytes, Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (FIB) and Plasminogen; Inhibitors, Protein C/S, Antithrombin (ATIII) and a2-antiplasmin; Factors, II, V, VII, VIII, vWF, IX, X, XI, and XII. Control Plasma N has additional analytes, Thrombin Time (TT), Batroxobin Time and Lupus anticoagulants.
D. Type of Test: Quantitative; clotting and chromogenic tests.
E. Applicant: Dade Behring, Inc.
F. Proprietary and Established Names: Dade Behring Control Plasma N and Dade Behring Control Plasma P

G. Regulatory Information:

1. Regulation section: 21 CFR 864.5425 – Multipurpose System for in vitro Coagulation Studies
2. Classification: Class II
3. Product code: GGN (Both controls); GIZ (Control Plasma N); GGC (Control Plasma P)
4. Panel: Hematology (81)

H. Intended Use:

1. Intended use(s): Control Plasma N and Control Plasma P are assayed controls used to monitor the performance of parameters in the normal and pathological ranges.
2. Indication(s) for use: Same as Intended Use.
3. Special conditions for use statement(s): N/A
4. Special instrument requirements: Mechanical and photo-optical instrumentation such as the Dade Behring BCS, BCT and Sysmex CA instruments.

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I. Device Description:

Control Plasma N and P and are prepared from pooled human plasma that is collected from healthy blood donors and stabilized with HEPES buffer. Control Plasma P is additionally adjusted to defined factor concentrations. Both plasmas are then lyophilized and supplied in 10 x 1 ml siliconized vials.

J. Substantial Equivalence Information:

1. Predicate device name(s): Dade Behring Control Plasma N; Dade Behring Control Plasma P
2. Predicate 510(k) number(s): #K023309; #K023312
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Configuration | Pooled human plasma in HEPES buffer | Same |
| Stability (reconstituted) | (4) hours at 2° – 15° C.;
(4) weeks at -20° C. | Same |
| Instrumentation | Mechanical and photo-optical instruments | Same |
| Calibration | WHO based and in-house standards | Same |
| | | |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Value assignment process | Values declared from the mean ± 2SD of previous lots of control | Values assigned on (2) lots of control, from duplicates run on (3) different instruments. |

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

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L. Test Principle:

The Dade Behring BCT, BCS and Sysmex CA analyzers are examples of mechanical and photo-optical coagulation systems, on which the control plasmas may be used.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: Retrospective data from Control Plasma N (N = 68) and Control Plasma P (N = 54) were applied to determine value assignment.

For Control Plasma N, all parameters generated mean values that fell within 2.1 – 4.5 % CV.

For Control Plasma P, all parameters generated mean values that fell within 3.0 – 8.1% CV.

b. Linearity/assay reportable range: N/A

c. Traceability, Stability, Expected values (controls, calibrators, or methods): World Health Organization (WHO) based reference preparations and 2° in-house standards.

d. Detection limit: N/A

e. Analytical specificity: N/A

f. Assay cut-off: N/A

2. Comparison studies:

a. Method comparison with predicate device: N/A

b. Matrix comparison: N/A

3. Clinical studies:

a. Clinical Sensitivity: N/A

b. Clinical specificity: N/A

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

4. Clinical cut-off: N/A

5. Expected values/Reference range: Control Plasma N generates values within the normal range for monitored parameters. Control Plasma P generates values within the pathological range for monitored parameters.

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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