ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)

K073377 · Instrumentation Laboratory CO · GKP · May 4, 2008 · Hematology

Device Facts

• Record ID: K073377
• Device Name: ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
• Applicant: Instrumentation Laboratory CO
• Product Code: GKP · Hematology
• Decision Date: May 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5400
• Device Class: Class 2

Indications for Use

The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurements and calculated parameters.

Device Story

ACL TOP is a benchtop, fully automated, random access analyzer for in vitro diagnostic coagulation and fibrinolysis testing. Used in clinical hemostasis laboratories by trained personnel. Device processes patient samples to provide direct hemostasis measurements and calculated parameters for assessing thrombosis and hemostasis. System Software V3.0.0 updates the operating system from Windows 2000 to Windows XP and includes ease-of-use enhancements. Instrument supports optional closed tube sampling. Output is used by clinicians to aid in diagnostic assessment of patient coagulation status.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the fact that the software update does not alter the analytical performance or clinical indications of the device.

Technological Characteristics

Benchtop, fully automated, random access coagulation analyzer. Software update (V3.0.0) migrates OS from Windows 2000 to Windows XP. Instrument supports optional closed tube sampling. No changes to hardware or test parameters.

Indications for Use

Indicated for in vitro diagnostic clinical use in hemostasis laboratories for coagulation and/or fibrinolysis testing to assess thrombosis and/or hemostasis.

Regulatory Classification

Identification

A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

Special Controls

*Classification.* Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument 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

• ACL TOP (K063679)

Submission Summary (Full Text)

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

A. 510(k) Number: K073377

B. Purpose for Submission: Software modification

The ACL TOP has two modules: (1) The Control Module handles the instrument's user interface, and (2) The Analytical Module is responsible for the patient sampling processing and data generation. System software V3.0.0 is being introduced on the ACL TOP family (with and without the feature of closed tube sampling) to support the conversion from the Windows 2000 Operating System to the Windows XP Operating System, which affects the Control Module. This software also includes additional features and ease-of-use enhancements (non-analytical improvements).

C. Manufacturer and Instrument Name: Instrumentation Laboratory Co., ACL TOP

D. Type of Test or Tests Performed: Coagulation and/or fibrinolysis

E. System Descriptions:

1. Device Description: K063679
2. Principles of Operation: K063679
3. Modes of Operation: K063679
4. Specimen Identification: K063679
5. Specimen Sampling and Handling: K063679
6. Calibration: K063679
7. Quality Control: K063679
8. Software:

FDA has reviewed applicant's Hazard Analysis and Software Development processes for this line of product types:

☑ Yes ☐ No

F. Regulatory Information:

1. Regulation section: Coagulation Instrument

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2. Classification: Class II
3 Product code: GKP
4. Panel: Hematology

G. Intended Use:

1. Indication(s) for Use:

The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurement and calculated parameter.

2. Special Conditions for Use Statement(s): N/A

H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers: ACL TOP, K063679 and K033414
2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device Software V3.0.0 | Predicate Software V2.8.7 |
| Intended Use | Same | The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurement and calculated parameter. |
| Differences | | |
| --- | --- | --- |
| Item | Device Software V3.0.0 | Predicate Software V2.8.7 |
| Software | Windows XP Operating System | Windows 2000 Operating System |

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I. Special Control/Guidance Document referenced (if applicable): N/A

J. Performance Characteristics: see K063679

1. Analytical Performance:
a. Accuracy:
b. Precision/Reproducibility:
c. Linearity:
d. Carryover:
e. Interfering Substances:

2. Other Supportive Instrument Performance Data Not Covered Above:

K. Proposed Labeling:

There are no changes in the ACL TOP test parameters, which are separate from the system software. Therefore, there are no changes to the labeled indications for use/intended use or performance claims of either the instruments or its reagents.

L. Conclusion:

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