HEMOSIL SYNTHASIL

K060688 · Instrumentation Laboratory CO · GFO · Apr 13, 2006 · Hematology

Device Facts

• Record ID: K060688
• Device Name: HEMOSIL SYNTHASIL
• Applicant: Instrumentation Laboratory CO
• Product Code: GFO · Hematology
• Decision Date: Apr 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7925
• Device Class: Class 2

Indications for Use

The HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems

Device Story

HemosIL SynthASil is a synthetic phospholipid reagent used for in vitro diagnostic testing of human citrated plasma. It functions as a reagent in coagulation analyzers (IL Coagulation and ELECTRA Systems) to measure Activated Partial Thromboplastin Time (APTT). The device is used in clinical laboratory settings by trained technicians to evaluate the intrinsic coagulation pathway and monitor heparin therapy. This specific submission optimizes APTT parameter settings on ACL Futura and ACL Advance instruments to improve correlation with the ACL TOP system. The output is a time-based measurement (seconds) representing the clotting time of the plasma sample, which clinicians use to assess coagulation status and adjust anticoagulant therapy.

Clinical Evidence

No clinical data. Bench testing only; sponsor provided risk analysis and Declaration of Conformity with Design Controls confirming development activities and product specifications were met.

Technological Characteristics

Synthetic phospholipid reagent for APTT determination. Designed for use on IL Coagulation and ELECTRA Systems. Optimized for specific instrument parameter settings (ACL Futura and ACL Advance).

Indications for Use

Indicated for in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma. Used for evaluation of intrinsic coagulation pathway, APTT substitution testing, and monitoring of heparin therapy.

Regulatory Classification

Identification

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

Predicate Devices

• HemosIL SynthASil (K953981)

Submission Summary (Full Text)

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

A. 510(k) Number:
K060688

B. Purpose for Submission:
Special submission for a modification to the APTT parameter settings for HemosIL SynthASil on the ACL Futura and ACL Advance which allows for improved correlation with the ACL TOP

C. Analyte:
Activated Partial Thromboplastin Time (APTT)

D. Type of Test:
Clotting

E. Applicant:
Instrumentation Laboratories

F. Proprietary and Established Names:
HemosIL SynthASil

G. Regulatory Information:
1. Regulation section:
21 CFR 864.7925
2. Classification:
Class II
3. Product Code:
GFO
4. Panel:
81 Hematology

H. Intended Use:
1. Intended use(s):
The HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems
2. Indication(s) for use:
3. Special condition for use statement(s):
4. Special instrument Requirements:
IL Coagulation and ELECTRA Systems

I. Device Description:
The HemosIL SynthASil is a phospholipid reagent for the in vitro determination of APTT in human citrated plasma. It is used for the evaluation of the intrinsic coagulation pathway, and the monitoring of heparin therapy.

J. Substantial Equivalence Information:
1. Predicate device name(s):
HemosIL SynthASil

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2. Predicate K number(s):
K953981

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Hemosil SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of APTT in human citrated plasma on IL Coagulation and ELECTRA Systems | same |
| Test Principle | When sample testing is initiated, sample, APTT reagent, a negatively charged contact activator and buffer are incubated at 37°C for a specific period of time which initiates the activation of the intrinsic coagulation pathway. Calcium is them added to trigger the coagulation process and the time required for clot formation is measured. | same |
| Differences | | |
| Item | Device | Predicate |
| Normalized Curve Smoothing | 1 | 9 |
| Offset % | 67 | 35 |

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

L. Test Principle:
See table above

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
b. Linearity/assay reportable range:
c. Traceability (controls, calibrators, or method):

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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): As required for a Special 510(k), the Sponsor has provided a risk analysis as well as a Declaration of Conformity with Design Controls indicating that development activities were conducted under appropriate design controls procedures, and the overall product specifications were met.

4. Clinical cut-off:

5. Expected values/Reference range:

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