BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR

K043451 · Hyphen Biomed · GGN · Mar 17, 2005 · Hematology

Device Facts

• Record ID: K043451
• Device Name: BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
• Applicant: Hyphen Biomed
• Product Code: GGN · Hematology
• Decision Date: Mar 17, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

The Biophen plasma calibrator is used as a calibrator in the assay for the Antithrombin III & Protein C. It can be also used as normal human plasma control. The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.

Device Story

Biophen Plasma Calibrator, Normal Control Plasma, and Abnormal Control Plasma are lyophilized, citrated human plasma products. Used as calibrators and quality control materials in clinical coagulation laboratories. Reconstituted with distilled water before use. Analyzed via mechanical or photo-optical coagulation instrumentation. Provides reference values for ATIII, Protein C, and Lupus Anticoagulant assays. Ensures accuracy and precision of coagulation testing by providing standardized control points for clinical decision-making regarding hemostasis and thrombosis risk.

Clinical Evidence

No clinical data. Bench testing only. Device performance is validated through established coagulation assay parameters (ATIII, Protein C, Lupus Anticoagulant) and APC resistance ratios (≥2.00 for Normal Control).

Technological Characteristics

Lyophilized citrated normal human pooled plasma (>75%). Additives: Hepes (<10 mg), Glycine (<25 mg), Ciprofloxacin (<0.001%). Reconstituted with 1 ml distilled water. Form factor: 12 vials. No electronic or software components.

Indications for Use

Indicated for use as calibrators and quality control materials for coagulation assays measuring Antithrombin III (ATIII), Protein C, and Lupus Anticoagulant in human plasma samples.

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

• Plasma Control N (K001256)
• Lyphochek Hemostasis Control (K020878)

Submission Summary (Full Text)

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

A. 510(k) Number:
K043451

B. Purpose for Submission:
The is a bundled submission for the clearance of 3 devices

C. Measurand:
Antithrombin III (ATIII), Protein C, and Lupus Anitcoagulant

D. Type of Test:
Assayed Quality Control Material

E. Applicant:
Hyphen BioMed

F. Proprietary and Established Names:
Biophen Plasma Calibrator
Biophen Normal Control Plasma
Biophen Abnormal Control Plasma

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

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3. Product code:
GGN

4. Panel:
81

H. Intended Use:

1. Intended use(s):
The Biophen Plasma Calibrator is normal citrated human plasma used as the calibrator in the assay methods for coagulation factors such as ATIII and Lupus Anticoagulant.

The Biophen Normal Control Plasma is a set of 12 vials of normal citrated human plasma for the quality control of ATIII and Lupus Anticoagulant.

The Biophen Abnormal Control Plasma is a set of 12 vials of normal citrated human plasma for the quality control of ATIII and Lupus Anticoagulant.

2. Indication(s) for use:

3. Special conditions for use statement(s):

4. Special instrument requirements:

I. Device Description:

Biophen Plasma Calibrator reagent is composed of citrated normal human plasma, lyophilized in the presence of additives and preservatives. Each kit contains 12 vials of lyophilized reagent to be reconstituted with 1 ml distilled water. The concentration of the various coagulation factors is determined from the international standard.

The Biophen Normal and Abnormal Control Plasmas are lyophilized control material prepared from pooled plasma from selected health donors. Each control is calibrated for each parameter against a normal citrated human plasma pool and against

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international standard when available. ATIII and Protein C is confirmed against SSC/ISTH Secondary Coagulation Standard (lot #2), which has an assigned value of 96% activity and 97% antigen for Protein C and 92% activity and 93% antigen for ATIII. Both controls are negative for lupus anticoagulant, and the Biophen Normal Control Plasma is also tested for the absence of activated protein C resistance (APC-r).

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Dade Behring Control Plasma N

Bio-Rad Lyphochek Hemostasis Control

HemosIL Calibration Plasma

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

K001256

K020878

K041905

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 | ATIII, Protein C, Lupus Anticoagulant | PT, aPTT, TT, Batroxobin Time |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | | Fibrinogen, coagulation factors II, V, VII,IX,X,XII, ATIII, Pro C, α-2 antiplasmin, plasminogen, ProC, APC |
| Stability | 8 hrs- RT/24 hrs 2-8°C | 4 hrs-RT/4 weeks -20- -30°C |
| Similarities- Lyphochek Hemostasis Control | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | To provide quality control in the normal range | same |
| Matrix | Stabilized polled human plasma | same |
| Form | Lyophilized | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | ATIII, Protein C, Lupus Anticoagulant | PT, aPTT, TT, Fibrinogen, coagulation factor II, V, VII,VIII, IX,X,XI, XII, ATIII, Pro C (functional), Protein S (functional), plasminogen, |
| Stability | 8 hrs- RT/24 hrs 2-8°C | 8 hrs-RT except Protein S-8 hrs at 2-8°C |
| Similarities- HemosIL Calibration Plasma | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix | Stabilized reagent prepared from pooled human plasma | same |
| Intended Use | For the calibration of coagulation assays | same |
| Form | Lyophilized | same |

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| Similarities- HemosIL Calibration Plasma | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Volume | 1 ml | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | ATIII, Protein C, | Coagulation factor VII, ATIII, Pro C, Pro S, plasminogen, von Willebrand factor, Plasma inhibitor |

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

# L. Test Principle:

# M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The following values were obtained for one lot of Calibrator, Normal Control, and Abnormal Control.

| | %CV | | |
| --- | --- | --- | --- |
| | Calibrator | Norm Control | Abnormal Control |
| ATIII | 1.5 | 1.4 | 1.5 |
| Pro C | 1.45 | 1.8 | 1.4 |

b. Linearity/assay reportable range:

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

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The values assigned to the Biophen plasma calibrator are determined over multiple runs against a calibration standard which is traceable to the international standard, SSC/ISTH Secondary Coagulation standard lot#2. The value of the SSC/ISTH Secondary Coagulation standard lot#2 is determined against NIBSC 1st International standard for Protein C and against the NIBSC 2nd International standard for Antithrombin.

The Biophen Normal and Abnormal Control Plasma are calibrated for each parameter against a normal citrated human plasma pool and against internal standards, when available

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):

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4. Clinical cut-off:

5. Expected values/Reference range:

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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