ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)

K160276 · Instrumentation Laboratory CO · GKP · Mar 3, 2016 · Hematology

Device Facts

• Record ID: K160276
• Device Name: ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
• Applicant: Instrumentation Laboratory CO
• Product Code: GKP · Hematology
• Decision Date: Mar 3, 2016
• Decision: SESE
• Submission Type: Special
• 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 family instruments; automated coagulation analyzers. Modification: software update to version 5.3.0; migration of underlying operating system from Windows XP to Windows 7. Input: clinical samples for PT and APTT assays. Operation: instrument performs coagulation analysis; software manages system control and data processing. Output: coagulation assay results. Used in clinical laboratory settings by trained laboratory personnel. Modification impact: software verification and validation performed at unit, integration, and system levels; risk analysis confirmed no new patient or safety risks. Fundamental scientific technology remains unchanged.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation activities conducted at unit, integration, and system levels. System-level test protocols and results provided for PT and APTT assays to confirm performance post-software update.

Technological Characteristics

Bench-top, fully automated, random access coagulation analyzer. Optical measurement system (405 nm/671 nm). Performs coagulometric, chromogenic, and immunological assays. Software-controlled; OS updated to Windows 7. Uses proprietary reagents, calibrators, and controls.

Indications for Use

Indicated for use with the ACL TOP family of instruments (ACL TOP 700, 700 CTS, 700 LAS, 500 CTS, and 300 CTS) for coagulation testing.

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 (K073377)
• ACL TOP (K091980)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 3, 2016

Instrumentation Laboratory (IL) Co. Nikita Malladi Regulatory Affairs Specialist II 180 Hartwell Road Bedford, MA 01730

Re: K160276

Trade/Device Name: ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation Instrument Regulatory Class: Class II Product Code: GKP Dated: February 1, 2016 Received: February 2, 2016

Dear Ms. Malladi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Kelly Oliner S

For Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### Device Name

ACL TOP (ACL TOP 700; ACL TOP 700 CTS; ACL TOP 700 LAS; ACL TOP 500 CTS; ACL TOP 300 CTS)

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size: 10pt;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
| | <span> <span style="font-size: 10pt;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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# 510(k) Summary

The submission meets the criteria for a Special 510(k) under the FDA guidance "The New 510(k) Paradigm -Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".

| Submitter's Information | Instrumentation Laboratory (IL) Co.<br>180 Hartwell Road<br>Bedford, MA 01730, USA |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Nikita Malladi, Regulatory Affairs Specialist II<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Preparation Date | February 24, 2016 |
| Device Trade Name | ACL TOP:<br>ACL TOP 700 ACL TOP 700 CTS ACL TOP 700 LAS ACL TOP 500 CTS ACL TOP 300 CTS |
| Regulatory Information | Classification: Class II<br>Regulation No.: 21 CFR 864.5400<br>Common Name: Coagulation Instrument<br>Panel: Hematology (81)<br>Product Code: GKP |
| Predicate Device | ACL TOP: K073377; K091980 (LAS model) |
| Device Indications for Use /<br>Intended Use | The ACL TOP is a bench top, fully automated, random access<br>analyzer designed specifically for in vitro diagnostic clinical use in<br>the hemostasis laboratory for coagulation and/or fibrinolysis testing<br>in the assessment of thrombosis and/or hemostasis. The system<br>provides results for both direct hemostasis measurements and<br>calculated parameters. |
| Device Description | The ACL TOP Family are fully automated coagulation analyzers that<br>utilize the same intuitive software, the same consumables,<br>reagents, calibrators and controls, and provide the same analytical<br>methodology for routine and specialty assay result reporting as the<br>predicate ACL TOP Family.<br>The ACL TOP Family instrument performs the following types of<br>tests, using the same optical measuring wavelengths and test<br>parameters as the predicate ACL TOP Family:<br>Coagulometric (Turbidimetric) Measurements Chromogenic (Absorbance) Measurements Immunological Measurements |

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# Comparison to Predicate:

This Special 510(k) is being submitted to switch the operating system from Windows XP to Windows 7 for ACL TOP Family Instruments.

The submission meets the criteria for a Special 510(k) based on the following:

- No change in indications for use or intended use
- No change in operating principle ●
- No change to labeled performance claims, for the instrument family of the associated reagents
- No change to hardware
- No change to data reduction software
- No change to test parameters
- No change to calibration ●
- No change to quality controls
- No change to consumables
- No change to reagents

Following is a description of the similarities and differences between the currently marketed ACL TOP Family (K073377, K091980 (LAS model) ) and ACL TOP Family with the Software 5. 3 update:

| Item | Predicate | Updated Device (with SW 5.3) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Trade Names | ACL TOP ACL TOP 700 ACL TOP 700 CTS ACL TOP 700 LAS ACL TOP 500 CTS ACL TOP 300 CTS | ACL TOP ACL TOP 700 ACL TOP 700 CTS ACL TOP 700 LAS ACL TOP 500 CTS ACL TOP 300 CTS |
| Indications for Use | The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for <i>in vitro</i> diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.<br>The system provides results for both direct hemostasis measurements and calculated parameters. | Same |
| Matrix | 3.2% Citrated Plasma | Same |
| Methodology | The ACL TOP Family performs the following types of tests: Coagulometric (Turbidimetric) Measurements (405 nm or 671 nm) Chromogenic (Absorbance) Measurements (405 nm) Immunological Measurements (405 nm or 671 nm) | Same |
| Test Menu | Clotting, chromogenic and immunological assays | Same |
| Quality Control | Automated QC | Same |
| Software<br>(Operating System) | Windows XP | Windows 7 |

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# Conclusion:

Based on the shared indications for use, operating principle, consumables, reagents, controls and calibrators, the ACL TOP Family with software v5.3 running on the Windows 7 operating system can be concluded to be substantially equivalent to the cleared and currently marketed predicate device, ACL TOP Family.