ACL TOP

K063679 · Instrumentation Laboratory CO · GKP · Jan 12, 2007 · Hematology

Device Facts

• Record ID: K063679
• Device Name: ACL TOP
• Applicant: Instrumentation Laboratory CO
• Product Code: GKP · Hematology
• Decision Date: Jan 12, 2007
• 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

Instrument performs intrinsic and extrinsic factor assays; modification optimizes assay performance. Input: patient samples; calibration via direct aspiration from vials. Processing: polynomial curve fitting or segmented calibration curves; optimized incubation times, transport air gaps, and probe rinse parameters. Output: assay results for clinical decision-making. Used in clinical laboratory settings by trained personnel.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing of the optimized factor assay applications to demonstrate performance consistency with the predicate device.

Technological Characteristics

Benchtop, fully automated, random access coagulation analyzer. Features include automated sample handling, probe-based aspiration, and incubation systems. Software-controlled assay parameters include calibration curve generation (polynomial and segmented fitting), direct dilution, and optimized fluidic/incubation timing. Connectivity and specific material standards are not detailed.

Indications for Use

Indicated for in vitro diagnostic clinical use in hemostasis laboratories for coagulation and/or fibrinolysis testing to assess thrombosis and/or hemostasis.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K063679

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. (For a preamendments device, a statement to this effect has been provided.)

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: optimizing the performance of the intrinsic and extrinsic factor assay applications on the instrument.

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

Major software and test parameter modifications include:

- The calibration levels are now prepared by aspirating the calibrator directly from the calibrator vial (direct dilution instead of serial dilution)
- Increase number of calibration points depending on the individual factor
- New mathematical tool for calibration curve generation, e.g. polynomial curve fitting capability as well as the capability of using segmented calibration curve
- Increase the robustness of the assay by optimizing incubation time, transport air gap and probe rinse parameter modifications.

Method comparison study was acceptable.

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
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

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6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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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revised: 8/1/03