ACL TOP 970 CL

K233790 · Instrumentation Laboratory · JPA · Dec 29, 2023 · Hematology

Device Facts

• Record ID: K233790
• Device Name: ACL TOP 970 CL
• Applicant: Instrumentation Laboratory
• Product Code: JPA · Hematology
• Decision Date: Dec 29, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

The ACL TOP 970 CL is a multipurpose system for in vitro coagulation studies.

Device Story

The ACL TOP 970 CL is a benchtop, fully automated, random-access analyzer for in vitro diagnostic coagulation and fibrinolysis testing. It consists of two side-by-side modules: a Main Module (based on the ACL TOP 550 CTS) and a Chemiluminescent (CL) Module. The device accepts clinical samples and performs coagulometric (turbidimetric), chromogenic (absorbance), and immunological measurements using optical wavelengths (405, 535, 671 nm). It features automated pre-analytical checks for HIL (Hemoglobin, Icteric, Lipemia) interference, underfilled tubes, and clogs. Operated by laboratory professionals, the system automates fluid handling, mixing, and temperature-controlled incubation. Output consists of quantitative assay results and calculated parameters, which clinicians use to assess thrombosis and hemostasis. The device shares reagents, calibrators, and controls with the predicate ACL TOP Family 50 Series.

Clinical Evidence

No clinical data; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of the modified hardware module.

Technological Characteristics

Benchtop, fully automated, random-access analyzer. Uses optical detection (405, 535, 671 nm) for coagulometric, chromogenic, and immunological assays. Features include automated fluidic handling, temperature-controlled reagent/sample storage, and cap-piercing. Software controls hardware and user interface. Verification confirmed structural changes (skins, wall geometry, air intake) do not impact analytical results.

Indications for Use

Indicated for use by healthcare professionals in clinical laboratories to perform coagulation and/or fibrinolysis testing for the assessment of thrombosis and/or hemostasis.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies 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

K233790

B Applicant

Instrumentation Laboratory

C Proprietary and Established Names

ACL TOP 970 CL

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JPA | Class II | 21 CFR 864.5425 - Multipurpose System For In Vitro Coagulation Studies | HE - Hematology |

## II Review Summary:

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

1. The name and 510(k) number of the SUBMITTER'S previously cleared device (K221359).
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. This change was for the clearance for the Main Module (ACL

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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K233790 - Page 2 of 2

# TOP 550 CTS side; K150087) of the ACL TOP 970 CL instrument cleared under K221359.

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.