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

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 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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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K160276

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: ACL TOP, K073377; K091980 (LAS model)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for updating the instrument software to version 5.3.0 to support Windows 7 as the underlying operating system for ACL TOP family instruments (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, and ACL TOP 300 CTS).

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and assay methods. The difference is that the underlying operating system was changed from Windows XP to Window 7 in instrument software version 3.5.0. There are no other changes.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. A high level risk analysis and a detailed software risk analysis with mitigation information were provided in the Pre-Market Risk Analysis Worksheet and Software Hazard Analysis Report. In conclusion, no patient or safety risks are introduced.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. Descriptions of verification and validation activities were provided for the ACL TOP family instrument application software at the unit, integration, and system levels. System level test protocols, including pass/fail criteria, and test results for PT and APTT assays were also provided.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.