DADE THROMBIN REAGENT

K050928 · Dade Behring, Inc. · KQJ · Jun 29, 2005 · Hematology

Device Facts

• Record ID: K050928
• Device Name: DADE THROMBIN REAGENT
• Applicant: Dade Behring, Inc.
• Product Code: KQJ · Hematology
• Decision Date: Jun 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7340
• Device Class: Class 2

Indications for Use

For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology.

Device Story

Dade Thrombin Reagent is a diagnostic reagent used to measure fibrinogen concentration in human plasma. It functions based on the Clauss method, where thrombin is added to dilute plasma to convert soluble fibrinogen into an insoluble fibrin clot. The time required for clot formation is inversely proportional to the fibrinogen concentration. The reagent is also used to accelerate coagulation in anticoagulated samples for immunohematology. It is intended for use by laboratory professionals in clinical settings. The output is a clotting time measurement, which is compared against a standardized fibrinogen preparation to determine the patient's fibrinogen level, aiding in the assessment of coagulation status.

Clinical Evidence

Method comparison study performed comparing the modified Dade Thrombin Reagent to the predicate. Study involved 80 samples per lot. Results showed high correlation (r=0.995 and r=0.993) with slopes of 1.03 and 0.946 respectively, demonstrating substantial equivalence in performance.

Technological Characteristics

Reagent-based fibrinogen determination system. Operates via enzymatic conversion of fibrinogen to fibrin clot. Class II device, product code KQJ. No software, electronics, or connectivity features.

Indications for Use

Indicated for the quantitative determination of fibrinogen in human plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies.

Regulatory Classification

Identification

A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

Special Controls

*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system 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 Fibrinogen Determination Reagents kit (Pre-1976)
• Dade Thrombin Reagent (BK860038)

Submission Summary (Full Text)

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

A. 510(k) Number:
K050928

B. Purpose for Submission:
To obtain clearance for Dade® Thrombin Reagent and Dade® Owren's Veronal Buffer for use in the measurement of fibrinogen. Dade Behring is modifying the packaging configuration of the Dade® Fibrinogen Determination kits so that the kit components Dade® Thrombin Reagent and Dade® Owren’s Veronal Buffer may be sold separately. No changes are being made to the operating principle or reagent composition.

C. Measurand:
Fibrinogen

D. Type of Test:
Fibrinogen determination

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dade® Thrombin Reagent

G. Regulatory Information:
1. Regulation section:
21 CFR 864.7340
2. Classification:
Class II

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3. Product code:
KQJ

4. Panel:
81 Hematology

H. Intended Use:

1. Intended use(s):
For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology.

2. Indication(s) for use:
For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology.

3. Special conditions for use statement(s):

4. Special instrument requirements:

I. Device Description:

A quantitative assay for fibrinogen (Clauss method) is performed by measuring the clotting time of dilute plasma when excess thrombin is added. The clotting time obtained is then compared with that of a standardized fibrinogen preparation.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Dade® Fibrinogen Determination Reagents (pre-1976)
Dade® Thrombin Reagent

2. Predicate 510(k) number(s):
BK 860038

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Reagent Composition | Lyophilized preparation of bovine thrombin (approximately 100 NIH units) with stabilizers and buffers | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Assay components | Dade® Thrombin Reagent
Dade® Owren’s Veronal Buffer. Individually packaged and sold separately | Dade® Thrombin Reagent
Dade® Fibrinogen Standard
Dade® Owren’s Veronal Buffer |

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

Not applicable

L. Test Principle:

The enzyme thrombin converts the soluble plasma protein fibrinogen into its insoluble polymer fibrin. The clotting time for diluted plasma is inversely proportional to the fibrinogen concentration of the plasma. By using this principle, Clauss developed a simple procedure for determining fibrinogen based on measuring the clotting time of diluted plasma after the addition of thrombin. The clotting time obtained in this manner is then compared with that of a standardized fibrinogen preparation.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The Dade® Thrombin Reagent assay was used to measure fibrinogen concentrations ranging from 0.89 to 2.8 g/L in Control Plasma N (K045333), Control Plasma P (K042209), low plasma pool (PPL), normal plasma pool (PPN) and Dade Data Fi® abnormal fibrinogen control (aFCP) (K811069). Eight determination per day over 5 days (n=40) were performed using a Sysmex® CA-1500 analyzer. The following is a summary of precision data:

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| | Mean value (g/L) | Within run (% CV) | Between run (% CV) | Total (%CV) |
| --- | --- | --- | --- | --- |
| Control Plasma N | 2.6 | 5.9 | 0.0 | 5.9 |
| Control Plasma P | 0.89 | 4.8 | 0.0 | 4.8 |
| Low Plasma Pool | 0.95 | 7.1 | 2.3 | 7.4 |
| Normal Plasma Pool | 2.8 | 3.5 | 0.0 | 3.5 |
| Data Fi® Abnormal Control | 1.1 | 3.8 | 2.4 | 4.5 |

b. Linearity/assay reportable range:

Not applicable

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

Not applicable

d. Detection limit:

Not applicable

e. Analytical specificity:

Interference testing was performed to determine the effect of icterus, lipemia, hemolysis, and heparin on the Dade® Thrombin Reagent assay. Normal and abnormal plasma sample preparations were spiked with increasing concentrations of each interferent. For each spiked level, the % recovery was determined [%Recovery = (Test result / Baseline) x 100]. The acceptance criterion was established as 0.25 g/L relative deviation from the base pool.

| Material | No interference up to: |
| --- | --- |
| Bilirubin | 60 mg/dL |
| Hemoglobin | 600 mg/dL |
| Triglycerides | 728.6 mg/dL |
| Heparin (low molecular wt.) | 0.4 U/mL |
| Heparin (unfractionated) | 0.6 U/mL |

f. Assay cut-off:

Not applicable

2. Comparison studies:

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a. Method comparison with predicate device:

The Dade® Fibrinogen Determination Reagent kit was compared to the modified Dade® Thrombin Reagent assay by evaluating 80 plasma samples with concentrations ranging from 0.50 to 8.6 g/L using reference curves generated with two lots of Standard Human Plasma (SHP). Regression analysis yielded the following results:

SHP lot # 502587 - r = 0.995
SHP lot # 502589 - r = 0.993

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:

1.8 – 3.5 g/L

N. Proposed Labeling:

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

O. Conclusion:

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