ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)

K242127 · Instrumentation Laboratory (IL) Co. · GKP · Aug 16, 2024 · Hematology

Device Facts

• Record ID: K242127
• Device Name: ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
• Applicant: Instrumentation Laboratory (IL) Co.
• Product Code: GKP · Hematology
• Decision Date: Aug 16, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5400
• Device Class: Class 2

Indications for Use

The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) is intended for in vitro diagnostic use in clinical laboratories to perform coagulation and fibrinolysis testing on human citrated plasma samples.

Device Story

ACL TOP Family 50 Series: automated coagulation analyzers for clinical laboratories; process human citrated plasma samples to perform coagulation and fibrinolysis assays. Modification adds permission-based remote-control desktop sharing; enables remote delivery of software, OS patches, and test parameter updates. Device remains substantially equivalent to predicate K150877; fundamental scientific technology unchanged. System provides automated diagnostic results to clinicians for patient management.

Clinical Evidence

Bench testing only. Software verification and validation studies were conducted to confirm the safety and effectiveness of the new remote-access features and enhanced cybersecurity controls. No clinical performance data was required as the analytical performance remains unchanged from the predicate.

Technological Characteristics

Benchtop, fully automated, random access coagulation analyzer. Optical detection (405, 535, 671 nm). Fluidic handling includes aspiration, dispense, mixing, and temperature control. Connectivity: Cloud-based architecture for remote software/OS updates and desktop sharing. Software: Windows 10 (v6.5.3) with enhanced cybersecurity (MS BitLocker, Digital Signature, MS AppLocker).

Indications for Use

Indicated for in vitro diagnostic coagulation and fibrinolysis testing in clinical laboratories using human citrated plasma samples.

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 Family 50 Series (K150877)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K242127

B Applicant

Instrumentation Laboratory (IL) Co.

C Proprietary and Established Names

ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| GKP | Class II | 21 CFR 864.5400 - Coagulation Instrument | HE - Hematology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device K150877.
2. Submitter's statement that the INDICATIONS FOR USE/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. The changes include:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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- Added permission-based remote-control function for desktop sharing.
- Added functionality to remotely deliver software, OS updates (patches) and test parameter releases.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

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.

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.

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.

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