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

Intended 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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## ACL TOP System Software V3.0.0 510(k) Summary

#### Applicant Contact Information:

MAY 1 4 2008

| Applicant:<br>Address: | Instrumentation Laboratory Co.<br>113 Hartwell Avenue<br>Lexington, MA 02421 |
|-------------------------------------------------|------------------------------------------------------------------------------|
| Contact Person:<br>Phone Number:<br>Fax Number: | Carol Marble, Regulatory Affairs Director<br>781-861-4467<br>781-861-4207 |
| Preparation Date: | February 4, 2008 |

### Device Trade Name:

ACL TOP

### Regulatory Information:

| Regulation Section: | Coagulation Instrument (864.5400) |
|---------------------|-----------------------------------|
| Classification: | Class II |
| Product Code: | GKP |
| Panel: | Hematology |

#### Predicate Device:

K063679 ACL TOP

### Device Intended Use / Description:

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.

### Reason for Submission:

System Software V3.0.0 is being introduced on the ACL TOP family (instrument available 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. This software also includes additional features and ease-of-use enhancements.

### Statement of Technological Characteristics of the Device Compared to Predicate Device:

The performance of the ACL TOP family with System Software V3.0.0 is substantially equivalent to the performance of the current legally marketed ACL TOP (K063679).

- There are no changes in the ACL TOP test parameters (which are separate from the . system software) and therefore, no changes to the labeled indications for use/intended use or performance claims of either the instrument or its reagents.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 4 2008

Instrumentation Laboratory Co. C/O Carol Marble 113 Hartwell Avenue Lexington, Massachusetts 02421

Re: k073377

Trade/Device Name: ACL TOP (with System Software V3.0.0) Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation instrument Regulatory Class: Class II Product Code: GKP Dated: November 30, 2007 Received: December 3, 2007

Dear Ms. Marble:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Robert Becker

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

K073377 510(k) Number (if known): ___

Device Name: ACL TOP Family

## 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.

Prescription Use
(Part 21 CFR 801 Subpart D) √

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Auyline Bautista

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073377