HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED

K082859 · Instrumentation Laboratory CO · GGN · Dec 19, 2008 · Hematology

Device Facts

• Record ID: K082859
• Device Name: HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
• Applicant: Instrumentation Laboratory CO
• Product Code: GGN · Hematology
• Decision Date: Dec 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the normal range. The product is intended in the assessment of precision and accuracy for PT, APTT, and Fibrinogen tests performed on coagulation systems. HemosIL Routine Control Level 2 is for the quality control of coagulation assays in the low abnormal range. The product is intended in the assessment of precision and accuracy for PT, and APTT tests performed on coagulation systems. HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the high abnormal range. The product is intended in the assessment of precision and accuracy for PT, and APTT tests performed on coagulation systems.

Device Story

Lyophilized human citrated plasma controls; used for quality control of coagulation assays (PT, APTT, Fibrinogen). Level 1 derived from healthy donors; Levels 2 and 3 modified via dedicated process to simulate abnormal coagulation samples. Used in clinical laboratory settings on coagulation systems (e.g., ACL series) to assess precision and accuracy of test results. Healthcare providers use control results to verify system performance before patient sample analysis.

Clinical Evidence

Bench testing only. Precision/reproducibility assessed via within-run and between-run %CVs on ACL 9000, ACL Advance, ACL 300, and ACL 6000 systems using various HemosIL reagents. Real-time stability studies support 36-month shelf life for Level 1 and 24-month shelf life for Levels 2 and 3.

Technological Characteristics

Lyophilized human citrated plasma; contains buffers, stabilizers, and preservatives (Level 1 only). No preservatives in Levels 2 and 3. Intended for use on automated coagulation systems.

Indications for Use

Indicated for quality control of coagulation assays (PT, APTT, Fibrinogen) on coagulation systems to assess precision and accuracy. Level 1: normal range. Level 2: low abnormal range. Level 3: high abnormal range.

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

• HemosIL Normal Control (K021023)
• HemosIL Low Abnormal Control (K021022)
• HemosIL High Abnormal Control (K021024)

Submission Summary (Full Text)

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

A. 510(k) Number:
K082859

B. Purpose for Submission:
New Submission

C. Measurand:
PT, APTT, Fibrinogen

D. Type of Test:
Quantitative

E. Applicant:
Instrumentation Laboratory Co.

F. Proprietary and Established Names:
HemosIL Routine Control Level 1, 2, and 3

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
4. Panel:
81 Hematology

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H. Intended Use:

1. Intended use(s):

HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the normal range. The product is intended in the assessment of precision and accuracy for PT, APTT, and Fibrinogen tests performed on coagulation systems.

HemosIL Routine Control Level 2 is for the quality control of coagulation assays in the low abnormal range. The product is intended in the assessment of precision and accuracy for PT, and APTT tests performed on coagulation systems.

HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the high abnormal range. The product is intended in the assessment of precision and accuracy for PT, and APTT tests performed on coagulation systems.

2. Indication(s) for use:

Same as Intended Use

3. Special conditions for use statement(s):

N/A

4. Special instrument requirements:

N/A

I. Device Description:

The HemosIL Routine Control Level 1 is a lyophilized product prepared using human citrated plasma from healthy donors. It contains buffer, stabilizers and preservatives.

The HemosIL Routine Control Level 2 is a lyophilized product prepared using human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to stimulate an abnormal coagulation sample. It contains buffer and stabilizers. No preservatives are included.

The HemosIL Routine Control Level 3 is a lyophilized product prepared using human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to stimulate an abnormal coagulation sample. It contains buffer and stabilizers. No preservatives are included

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J. Substantial Equivalence Information:

1. Predicate device name(s):
K021023 HemosIL Normal Control
K021022 HemosIL Low Abnormal Control
K021024 HemosIL High Abnormal Control

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

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use: For the quality control of coagulation assays in the normal, low abnormal, and high abnormal range. | Same | K021023 HemosIL Normal Control, K021022 HemosIL Low Abnormal Control, K021024 HemosIL High Abnormal Control
Same |
| Matrix | Human Plasma | Same |
| Form | Lyophilized | Same |
| | | |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Assayed Control | Assayed Control | Unassayed Control |

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

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N/A

## L. Test Principle:

N/A

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

### 1. Analytical performance:

a. Precision/Reproducibility:

Within run precision was assessed over multiple runs using the three levels of HemosIL Routine Control with specific lots of reagents on representative coagulation systems: ACL 9000, ACL Advance, ACL 300, ACL 6000. ACL Advance, and ACL 300 for PT, APTT and Fibrinogen. Reagents used in the analysis included HemosIL PT-Fibrinogen Recombinant, HemosIL PT-Fibrinogen, HemosIL PT-Fibrinogen HS Plus, HemosIL APTT-SP, HemosIL SynthAFax, and HemosIL SynthASil. Within Run and Between Run %CVs were within the specifications.

b. Linearity/assay reportable range:

N/A

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

A real-time shelf-life study was performed using three lots of HemosIL Routine Control Level 1, 2, and 3. Vials of the control were tested in quadruplicate at Day 0 and stored at 2-8°C in the original vials for the duration of testing. At each time interval, the three lots of control were tested at a minimum in duplicate on a representative coagulation system using representative reagents. The data presented supports the real-time stability claim of 36 months for HemosIL Control Level I and 24 months for Level 2 and 3.

d. Detection limit:

N/A

e. Analytical specificity:

N/A

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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

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

4. Clinical cut-off:

N/A

5. Expected values/Reference range:

The reported Acceptance Ranges were determined over multiple runs on an ACL Classic System (100-7000) using specific reagents.

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.

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