BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR

K051472 · Hyphen Biomed · GGN · Dec 23, 2005 · Hematology

Device Facts

• Record ID: K051472
• Device Name: BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
• Applicant: Hyphen Biomed
• Product Code: GGN · Hematology
• Decision Date: Dec 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

The Biophen LMWH Control Kit is a set of control plasmas for the quality control of Low Molecular Weight Heparin (LMWH) measurements, using anti-Xa colorimetric assays. The Biophen LMWH Control Low Kit is a set of control plasmas for the quality control of Low Molecular Weight Heparin (LMWH) measurements, using anti-Xa colorimetric assays. The Biophen UFH Control Kit is a set of control plasmas for the quality control of Low Molecular Weight Heparin (LMWH) measurements, using anti-Xa colorimetric assays. The Biophen UFH Calibrator is a set of calibration plasmas for Unfractionated Heparin (UFH) measurements, using anti-Xa colorimetric assays. The Biophen Heparin Calibrator is a set of calibration plasmas for Heparin (UFH and LMWH) measurements, using anti-Xa colorimetric assays.

Device Story

Biophen Heparin/UFH Control Plasmas and Calibrators are in vitro diagnostic reagents used in clinical laboratories. Controls assess precision and accuracy of anti-Xa colorimetric assays (e.g., Biophen Heparin 3 & 6); calibrators establish the calibration curve for these assays. The device consists of plasma samples with known heparin concentrations. Laboratory technicians use these to validate assay performance before patient sample testing. By ensuring accurate measurement of heparin levels, the device assists clinicians in monitoring anticoagulant therapy, thereby optimizing therapeutic dosing and minimizing bleeding or clotting risks.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility studies demonstrated intra-assay %CV ranging from 0.5% to 2.3% across all control and calibrator levels. Traceability established via NIBSC International Standards for LMWH (85/600) and UFH (97/578).

Technological Characteristics

In vitro diagnostic plasma-based controls and calibrators. Principle of operation: chromogenic anti-Xa assay calibration and quality control. Form factor: liquid/lyophilized plasma. Connectivity: none (standalone reagents).

Indications for Use

Indicated for quality control and calibration of anti-Xa colorimetric assays used to measure Low Molecular Weight Heparin (LMWH) and Unfractionated Heparin (UFH) 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

• Instrumentation Laboratories Control Plasma LMW Heparin (K030965)
• American Bioproducts Heparin Control (K943520)
• Instrumentation Laboratories Calibration Plasma LMW Heparin (K030964)
• Dade Behring Heparin Calibrators and Controls (K042941)

Submission Summary (Full Text)

{0}

1

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

A. 510(k) Number:
K051472

B. Purpose for Submission:
This a bundled submission for the clearance of 5 devices

C. Measurand:
Low Molecular Weight Heparin (LMWH)
Unfractionated Heparin (UF)

D. Type of Test:
Quality Control Material

E. Applicant:
Hyphen BioMed

F. Proprietary and Established Names:
Biophen Low Molecular Weight Heparin (LMWH) Control Plasma
Biophen Low Molecular Weight Heparin (LMWH) Control Plasma Low
Biophen Unfractionated Heparin (UFH) Control Plasma
Biophen Heparin Calibrator,
Biophen Unfractionated (UFH) Calibrator

G. Regulatory Information:
1. Regulation section:
21 CFR 864.5425
21 CFR 864.7525

{1}

2. Classification:

Class II

3. Product code:

GGN, GGC, KFF

4. Panel:

81 Hematology

H. Intended Use:

1. Intended use(s):

The Biophen LMWH Control Kit is a set of control plasmas for the quality control of Low Molecular Weight Heparin (LMWH) measurements, using anti-Xa colorimetric assays.

The Biophen LMWH Control Low Kit is a set of control plasmas for the quality control of Low Molecular Weight Heparin (LMWH) measurements, using anti-Xa colorimetric assays.

The Biophen UFH Control Kit is a set of control plasmas for the quality control of Low Molecular Weight Heparin (LMWH) measurements, using anti-Xa colorimetric assays.

The Biophen UFH Calibrator is a set of calibration plasmas for Unfractionated Heparin (UFH) measurements, using anti-Xa colorimetric assays.

The Biophen Heparin Calibrator is a set of calibration plasmas for Heparin (UFH and LMWH) measurements, using anti-Xa colorimetric assays.

2

{2}

2. Indication(s) for use:
Same as Intended Use

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

4. Special instrument requirements:
Not applicable

I. Device Description:

Biophen UFH Control Plasma -12-1 mL vials of human plasma supplemented at 2 different concentrations of unfractionated heparin (6 vials at each concentration)

Biophen LMWH Control Plasma -12-1 mL vials of human plasma supplemented at 2 different concentrations of low molecular weight heparin (6 vials at each concentration)

Biophen LMWH Control Plasma Low -12-1 mL vials of human plasma supplemented at 2 different concentrations of low molecular weight heparin (6 vials at each concentration)

Biophen UFH Calibrator - 20 vials (4 sets of 5 vials) -1 mL vials of human plasma supplemented with different concentrations of unfractionated heparin (4 vials at each concentration)

Biophen Heparin Calibrator- 20 vials (4 sets of 5 vials) -1 mL vials of human plasma supplemented with different concentrations of unfractionated heparin (4 vials at each concentration)

{3}

4

J. Substantial Equivalence Information:

1. Predicate device name(s):
Instrumentation Laboratories Control Plasma LMW Heparin
American Bioproducts Heparin Control
Instrumentation Laboratories Calibration Plasma LMW Heparin
Dade Behring Heparin Calibrators and Controls.

2. Predicate 510(k) number(s):
K030965, K943520, K030964, K042941

3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | | |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | | |

K. Standard/Guidance Document Referenced (if applicable):
Not applicable

L. Test Principle:
Not applicable

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:

{4}

| | Intra-assay %CV |
| --- | --- |
| Biophen LMWH Control Level 3 | 1.9 |
| Biophen LMWH Control Level 4 | 1.5 |
| Biophen LMWH Control Low Level1 | 1.9 |
| Biophen LMWH Control Low Level 2 | 0.9 |
| Biophen UFH Control Level 1 | 1.1 |
| Biophen UFH Control Level 2 | 0.7 |
| | Intra-assay %CV |
| --- | --- |
| Biophen UFH Calibrator Cal 1 | na |
| Biophen UFH Calibrator Cal 2 | 1.4 |
| Biophen UFH Calibrator Cal 3 | 1.0 |
| Biophen UFH Calibrator Cal 4 | 0.5 |
| Biophen UFH Calibrator Cal 5 | 0.5 |
| | Intra-assay %CV |
| --- | --- |
| Biophen Heparin Calibrator Cal 1 | na |
| Biophen Heparin Calibrator Cal 2 | 2.3 |
| Biophen Heparin Calibrator Cal 3 | 0.5 |
| Biophen Heparin Calibrator Cal 4 | 1.0 |
| Biophen Heparin Calibrator Cal 5 | 0.5 |

b. Linearity/assay reportable range:

Not applicable

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

International Standard for protein for LMWH (NIBSC) (Code 85/600)

$5^{\text{th}}$ International Standard for UFH (NIBSC) (Code 97/578)

d. Detection limit

{5}

e. Analytical specificity:
f. Assay cut-off:

2. Comparison studies: Not applicable
a. Method comparison with predicate device:
b. Matrix comparison:

3. Clinical studies: Not applicable
a. Clinical Sensitivity:
b. Clinical specificity:
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

{6}

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, based on a Tier 1 review.

7