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 Description

The ACL TOP Family are fully automated coagulation analyzers that utilize the same intuitive software, the same consumables, reagents, calibrators and controls, and provide the same analytical methodology for routine and specialty assay result reporting as the predicate ACL TOP Family. The ACL TOP Family instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate ACL TOP Family: Coagulometric (Turbidimetric) Measurements Chromogenic (Absorbance) Measurements Immunological Measurements

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called ACL TOP. The purpose of this submission is to demonstrate that the updated ACL TOP device, which has switched its operating system from Windows XP to Windows 7, is substantially equivalent to its legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here is "Substantial Equivalence" to the predicate device. For a Special 510(k) submission, this means there are no changes to the indications for use or operating principle, and no changes to labeled performance claims, hardware, data reduction software, test parameters, calibration, quality controls, or consumables/reagents.

Characteristic	Predicate Device (ACL TOP Family with Windows XP)	Updated Device (ACL TOP Family with Software v5.3 on Windows 7)	Acceptance Criteria (Substantial Equivalence)
Trade Names	ACL TOP (multiple models)	Same	Same
Indications for Use	Described in document	Same	Same
Matrix (Sample Type)	3.2% Citrated Plasma	Same	Same
Methodology	Coagulometric, Chromogenic, Immunological	Same	Same
Test Menu	Clotting, chromogenic, immunological assays	Same	Same
Quality Control	Automated QC	Same	Same
Operating System	Windows XP	Windows 7	Functionally no change to performance
Operating Principle	Described in document	Same	Same
Labeled Performance Claims	Not explicitly detailed, but assumed stable	Same	Same
Hardware	Not explicitly detailed, but assumed stable	No change	No change
Data Reduction Software	Not explicitly detailed, but assumed stable	No change	No change
Test Parameters	Not explicitly detailed, but assumed stable	No change	No change
Calibration	Not explicitly detailed, but assumed stable	No change	No change
Consumables / Reagents	Not explicitly detailed, but assumed stable	No change	No change

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This is a Special 510(k) submission primarily focused on an operating system change, where the core assumption is that due to no changes in critical operational aspects (hardware, reagents, methodology, etc.), the performance remains substantially equivalent to the predicate. Such submissions typically rely on verification and validation activities demonstrating that the new software does not negatively impact existing performance, rather than a full clinical study with a patient test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This type of submission relies on technical verification and validation of the software change, ensuring that it operates as intended and does not alter the established clinical performance of the device previously demonstrated for the predicate. There is no mention of expert-established ground truth for a clinical test set in this document.

4. Adjudication Method for the Test Set

Not applicable. As noted above, there is no clinical test set described that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This document does not mention a MRMC comparative effectiveness study. This device is a coagulation instrument, not an AI-assisted diagnostic imaging device that would typically undergo such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is an automated coagulation analyzer. Its "standalone" performance is its fundamental operation (i.e., producing test results). The change to the operating system is intended to maintain this standalone performance. No separate "algorithm-only" study distinct from the device's inherent function is described in the context of this submission.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the established and cleared performance of the predicate ACL TOP Family devices. The updated device is considered substantially equivalent if it performs identically or comparably to the predicate for all stated measurement parameters and clinical indications. The document describes the device's functionality as "results for both direct hemostasis measurements and calculated parameters," implying that the accuracy of these measurements against established principles and validated methods would be the "ground truth" for the device's function.

8. The Sample Size for the Training Set

Not applicable. This device is an in-vitro diagnostic instrument for coagulation testing, not a machine learning or AI algorithm in the context of a "training set" as commonly referred to in AI development. The software change is an operating system update, which would involve software development and testing, but not typically a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the AI sense for this device. The ground truth for the device's performance would have been established during the development and clearance of the predicate devices, likely through extensive analytical and clinical validation studies against reference methods and clinical outcomes.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 system provides results for both direct hemostasis measurements and calculated parameters.

Type of Use (Select one or both, as applicable)
	☑ Prescription Use (Part 21 CFR 801 Subpart D)
	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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.180 Hartwell RoadBedford, MA 01730, USA
Contact Person	Nikita Malladi, Regulatory Affairs Specialist IIPhone: 781-674-3245Fax: 781-861-4207Email: nmalladi@ilww.com
Preparation Date	February 24, 2016
Device Trade Name	ACL TOP:ACL TOP 700 ACL TOP 700 CTS ACL TOP 700 LAS ACL TOP 500 CTS ACL TOP 300 CTS
Regulatory Information	Classification: Class IIRegulation No.: 21 CFR 864.5400Common Name: Coagulation InstrumentPanel: Hematology (81)Product Code: GKP
Predicate Device	ACL TOP: K073377; K091980 (LAS model)
Device Indications for Use /Intended Use	The ACL TOP is a bench top, fully automated, random accessanalyzer designed specifically for in vitro diagnostic clinical use inthe hemostasis laboratory for coagulation and/or fibrinolysis testingin the assessment of thrombosis and/or hemostasis. The systemprovides results for both direct hemostasis measurements andcalculated parameters.
Device Description	The ACL TOP Family are fully automated coagulation analyzers thatutilize the same intuitive software, the same consumables,reagents, calibrators and controls, and provide the same analyticalmethodology for routine and specialty assay result reporting as thepredicate ACL TOP Family.The ACL TOP Family instrument performs the following types oftests, using the same optical measuring wavelengths and testparameters as the predicate ACL TOP Family: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 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.	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(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.

Regulation Number and Section

§ 864.5400 Coagulation instrument.

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