HEMOSIL CALIBRATION PLASMA

K041905 · Instrumentation Laboratory CO · JIX · Sep 28, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041905
• Device Name: HEMOSIL CALIBRATION PLASMA
• Applicant: Instrumentation Laboratory CO
• Product Code: JIX · Clinical Chemistry
• Decision Date: Sep 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

HemosIL Calibration plasma is intended for the calibration of coagulation assays on IL and ELECTRA Coagulation Systems. The calibration plasma is prepared using citrated plasma plasmapheresed from healthy donors to maintain the characteristics of a normal plasma pool.

Device Story

HemosIL Calibration plasma is a multi-analyte calibrator derived from citrated plasma of healthy donors. It is used in clinical laboratory settings to calibrate coagulation assays on IL and ELECTRA Coagulation Systems. By providing a standardized reference material with known characteristics of a normal plasma pool, the device enables the instrument to establish accurate calibration curves for various coagulation parameters (e.g., APTT, PT, Fibrinogen, Factors). Healthcare providers use the resulting calibrated instrument output to ensure the accuracy of patient coagulation testing, which is essential for diagnosing and monitoring hemostatic disorders.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility testing performed on four IL coagulation instruments (n=32) per NCCLS EP5-T2; all analytes met within-run %CV specifications. Linearity studies confirmed assay reportable ranges with R² values of 0.9964–1.000. Stability testing supports 36-month shelf life and specific reconstituted stability claims (8-24 hours depending on analyte). Traceability established against WHO International Standards or House Standards.

Technological Characteristics

Multi-analyte calibrator consisting of citrated plasma from healthy donors. Designed for use with IL and ELECTRA Coagulation Systems. No specific materials, energy sources, or software algorithms are described as the device is a biological reference material.

Indications for Use

Indicated for the determination of PT, Fibrinogen, Single Factors, von Willebrand Factor, Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C, Protein S, and as a reference plasma for APTT and TT.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• HemosIL Assayed Reference Plasma-Normal (K905203)
• Assess Calibration Plasma (K002400)

Submission Summary (Full Text)

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

A. 510(k) Number:
K041905

B. Purpose for Submission:
To seek clearance for HemosIL Calibration plasma designed for calibration of coagulation assays on IL and ELECTRA Coagulation Systems.

C. Analyte:
PT, Fibrinogen, Single Factors, von Willebrand Factor, Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C, Protein S, and as a reference plasma for APTT and TT.

D. Type of Test:
Quantitative clotting assay

E. Applicant:
Instrumentation Laboratory Company

F. Proprietary and Established Names:
HemosIL Calibration plasma

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1150
2. Classification:
Class II
3. Product Code:
JIX
4. Panel:
81 Hematology

H. Intended Use:
1. Intended use(s):
HemosIL Calibration plasma is intended for the calibration of coagulation assays on IL and ELECTRA Coagulation Systems.
2. Indication(s) for use:
Used for the determination of PT, Fibrinogen, Single Factors, von Willebrand Factor, Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C, Protein S, and as a reference plasma for APTT and TT.

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

4. Special instrument Requirements:
Not applicable

I. Device Description:
HemosIL Calibration plasma is calibration plasma is lyophilized human plasma prepared using citrated plasma plasmapheresed from healthy donors containing buffers, stabilizers and preservatives to maintain the characteristics of a normal plasma pool.

J. Substantial Equivalence Information:

1. Predicate device name(s):
(a) HemosIL Assayed Reference Plasma – Normal (for ELECTRA) Series Analyzers)
(b) Assess Calibration Plasma (for ACL Family of Analyzers)

2. Predicate K number(s):
(a) K905203
(b) K002400

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Sample Type | HemosIL Calibration plasma | Assess Calibration Plasma |
| Storage Conditions | Citrated plasma | Citrated plasma |
| | Refrigerate 2-8°C until expired | Same |
| Differences | | |
| Item | Device | Predicate |
| Composition/Manufacturing | Lyophilized citrated plasma plasmapheresed from healthy human donors containing buffer (Hepes), dextran and preservatives: ciprofloxacin and sodium omadine. | Lyophilized citrated human plasma containing buffer (Hepes), dextran and glycine (no preservatives). |
| Assigned Values | Same list as Assess Calibration Plasma with the addition of: APTT, PT, & TT. | Antithrombin, Factors, Fibrinogen, Alpha-2-Antiplasmin, Plasminogen, Protein C, Protein S, von Willebrand Factor |

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

L. Test Principle:
Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:
Precision testing was performed as part of the value assignment process by running HemosIL Calibration plasma in replicates of eight on four different IL coagulation instruments (n=32) with the IL reagent listed below. The within-run, between-run and total %CV were calculated per NCCLS Document EP5-T2. All analytes met their specification for within-run %CV.

CV ranges for IL reagents and IL coagulation instruments (n=32)

| Analyte | Within-run %CV | Between-run %CV | Total %CV | Within-Run CV Specification |
| --- | --- | --- | --- | --- |
| APTT (seconds) | 0.35-1.85 | 0.43-2.17 | 0.74-5.52 | ≤ 5 % |
| Antithrombin (%) | 1.09-2.31 | 0.00-4.02 | 1.79-7.28 | ≤ 10 % |
| Factor II (%) | 1.81-8.70 | 0.00-5.42 | 1.81-10.25 | ≤ 10 % |
| Factor V (%) | 1.31-3.67 | 1.58-4.47 | 2.31-5.79 | ≤ 10 % |
| Factor VII (%) | 1.26-3.68 | 1.27-4.56 | 1.80-5.86 | ≤ 10 % |
| Factor VIII (%) | 4.21-6.65 | 1.27-4.63 | 4.47-8.10 | ≤ 10 % |
| Factor IX (%) | 2.62-9.09 | 2.03-2.80 | 3.80-9.32 | ≤ 10 % |
| Factor X (%) | 0.96-2.73 | 0.93-2.82 | 1.34-3.34 | ≤ 10 % |
| Factor XI (%) | 3.11-7.06 | 0.76-6.28 | 3.20-9.45 | ≤ 10 % |
| Factor XII (%) | 1.62-6.09 | 0.51-7.56 | 2.35-9.70 | ≤ 10 % |
| Factor VIII chromogenic (%) | 1.65-2.63 | 0.32-2.87 | 1.69-3.89 | ≤ 10 % |
| Fibrinogen-Clauss (mg/dl) | 1.98-6.72 | 1.16-3.18 | 2.41-6.82 | ≤ 15 % |
| Fibrinogen PT-based (mg/dl) | 2.03-5.91 | 0.00-6.28 | 2.07-7.53 | ≤ 15 % |
| Plasmin Inhibitor (%) | 1.65-3.16 | 1.49-6.38 | 2.51-7.11 | ≤ 10 % |
| Plasminogen (%) | 0.81-3.37 | 1.55-2.57 | 2.22-3.81 | ≤ 10 % |
| Protein C (%) | 1.42-6.96 | 1.52-10.61 | 2.07-12.50 | ≤ 10 % |
| Protein S (%) | 2.14-3.66 | 1.53-4.36 | 2.64-5.51 | ≤ 10 % |
| PT (seconds) | 0.61-3.20 | 0.00-2.12 | 0.91-3.37 | ≤ 5 % |
| TT (seconds) | 1.27-3.76 | 0.00-3.22 | 2.10-3.95 | ≤ 7 % |
| von Willebrand Factor (%) | 1.13-2.88 | 0.25-1.80 | 1.16-3.40 | ≤ 10 % |

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b. Linearity/assay reportable range:

| Analyte | Slope | R² | Intercept | Sample Range |
| --- | --- | --- | --- | --- |
| Antithrombin (%) | 0.9897 | 1.000 | 3.7142 | 19.7-113 % |
| Plasmin Inhibitor (%) | 1.0462 | 1.000 | -2.5797 | 31.0-109 % |
| Plasminogen (%) | 0.8763 | 1.000 | 3.1824 | 17.0-141 % |
| Protein C (%) | 1.0155 | 1.000 | 0.1110 | 24.1-132 % |
| Protein S (%) | 0.9643 | 1.000 | -0.5825 | 13.9-109 % |
| VWF (%) | 0.9141 | 1.000 | 1.7586 | 6.0-171 % |
| Factor V (%) with PT | 0.9886 | 1.000 | 0.3342 | 1.91-131 % |
| Factor VIII (%) with APTT | 1.1103 | 1.000 | -0.3741 | 0.36-134 % |
| Factor VIII (%) Chromogenic | 1.0711 | 1.000 | 5.6404 | 3.44-163 % |
| Fibrinogen (mg/dl) Clauss | 0.9532 | 0.9964 | 8.2089 | 98.2-601 mg/dl |

c. Traceability (controls, calibrators, or method):

The analyte values for HemosIL Calibration plasma have traceability to the International Standards listed below. If an International Standard is not available, then a House Standard is assigned against a pool of 100 normal donors.

| Analyte | WHO Standard Code No. |
| --- | --- |
| Antithrombin | 93/768 |
| Factor II | 94/746 |
| Factor V | House Standard |
| Factor VII | 94/746 |
| Factor VIII | 97/586 |
| Factor IX | 99/826 |
| Factor X | 94/746 |
| Factor XI | House Standard |
| Factor XII | House Standard |
| Fibrinogen (Derived) | 98/612 |
| Fibrinogen (Clauss) | 89/644 |
| Plasmin Inhibitor | House Standard |
| Plasminogen | House Standard |
| Protein C | 86/622 |
| Protein S | 93/590 |
| Von Willebrand Factor | 97/586 |

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d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:
Not applicable

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):

Stability:
Reconstituted stability testing was performed to support the following package insert claims for the new HemosIL Calibration plasma:
- 24 hours at 2-8°C in the original vial for PT, Fibrinogen, APTT, TT, Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C, Protein S
- 8 hours at 2-8°C in the original vial for the remaining parameters (Factors)
- 24 hours at -20°C in the original vial for PT and APTT

A shelf-life stability study is ongoing at 2-8°C using three different lots of HemosIL Calibration plasma. At time intervals of 0, 6 mo., 12 mo., 18 mo., 24 mo., 30 mo., and 36 mo., HemosIL Calibration plasma was run in quadruplicate and the results compared to the baseline at time zero. The results to date support a 36-month shelf life for HemosIL Calibration plasma.

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

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