ACL TOP MODEL, TOP

K033414 · Instrumentation Laboratory CO · GKP · Jan 12, 2004 · Hematology

Device Facts

• Record ID: K033414
• Device Name: ACL TOP MODEL, TOP
• Applicant: Instrumentation Laboratory CO
• Product Code: GKP · Hematology
• Decision Date: Jan 12, 2004
• Decision: SESE
• Submission Type: Abbreviated
• 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 is an automated, random-access coagulation analyzer for clinical laboratory use. It processes plasma samples or open-tube specimens, identified via barcode reader. A sample probe aspirates and dispenses samples, reagents, and diluents. The system performs coagulometric (turbidimetric), chromogenic (absorbance), and immunological measurements. It supports automated quality control programming and calibration using Assess Calibration Plasma. Healthcare providers use the resulting coagulation assay data to assess patient hemostasis and coagulation status, aiding in clinical decision-making for conditions related to clotting and bleeding disorders.

Clinical Evidence

Bench testing only. Precision assessed over 80 runs using normal and abnormal control plasma; %CV ranged from 0.9% to 9.1% across various assays (Antithrombin, APTT, D-Dimer, Factors II, V, VII, X, Fibrinogen, Protein C, PT). Method comparison study (n=93-205 samples) against ACL Advance showed high correlation (r=0.9587 to 0.9987) and statistical similarity in slopes and intercepts for all tested parameters.

Technological Characteristics

Benchtop, fully automated, random access coagulation analyzer. Utilizes optical/mechanical sensing principles for coagulation and fibrinolysis testing. Designed for in vitro diagnostic use in clinical laboratories. Connectivity and software details not specified beyond automated operation.

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 in patients.

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 Advance (K002400)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K033414

B. Instrument Name:
ACL TOP

C. System Descriptions:
1. Modes of Operation:
Automated, random access

2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X ☐ or No ☐

3. Sample Identification:
Samples, reagents and diluents are identified by a bar code reader

4. Specimen Sampling and Handling:
Samples- either open tube or plasma aliquoted into sample cups. A sample probe aspirates and dispenses materials from sample racks

5. Assay Types:
The ACL TOP is capable of performing the following coagulation assays:
Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and PT-based), D-Dimer, Protein C, Antithrombin and Intrinsic and Extrinsic Factor Assays

6. Reaction Types:
The ACL TOP performs coagulometric (turbidimetric), chromogenic (absorbance), and immunological measurements

7. Calibration:
Commercially available Assess Calibration Plasma (K002400)

8. Quality Control:
Allows for programming to automatically execute QC or generate a prompt when QC is due, when QC material has expired, or when QC has failed

D. Other Supportive Performance Characteristics Data Not Covered In The “L. Performance Characteristics” Section Of The SE Decision Summary.
The submission is an abbreviated 510(K) submitted in compliance to the guidance for Industry and FDA Staff- 510(k) Submissions for Coagulation Instruments

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Additional performance studies:

Onboard stability- To demonstrate that stability claim for manufactured liquids are met or exceeded. Analytical testing was performed, at suitable intervals, for longer than the expected stability of the reagent using validated controls. The percent recovery compared to the mean obtained using fresh material was evaluated.

Sample Carryover- samples of high concentration of analyte were analyzed prior to samples of low concentration of analyte. Test conditions: 4 replicates of analyte/run with no contamination present, 4 replicates contaminate samples/run, 8 replicates of recipient samples/run, 1 run/day over 1 day, 2 instruments. The percentage change of the recipient sample mean from the baseline mean was evaluated.

Reagent Carryover- Evaluated the effect observed when other reagents used by the system contaminate components of the system or test method. Reagent-to-reagent carryover for each contaminating reagent was tested for each test reagent. Test conditions: 8 replicates of analyte/run with no contamination present, 8 replicates contaminate reagent/run, 8 replicates of recipient analyte/run, 1 run/day over 1 day, 2 instruments. The percentage change of the recipient sample mean from the baseline mean was evaluated.

Parallelism Precision (factor Assays) - Factor precision was performed in accordance with NCCLS document H48-A for each of the extrinsic factors using the parallelism function of the ACL TOP.

Detection Limit (D-Dimer)- Detection limit studies for D-Dimer were performed on two ACL TOP analyzers by analyzing Factor Diluent (saline) in a run of twenty replicates on two ACL TOP Analyzers. The mean plus 3 SD was calculated and the maximum value was added to the reagent labeling.

Prozone (D-Dimer)- Dilutions of a prozone control containing a high concentration of D-Dimer (~100000 ng/mL) were prepared and analyzed in replicates of four on two ACL TOP analyzers. No prozone effect was seen up to 100000 ng/mL)

E. Other Supportive Information:

Heparin Response Curve (APTT) – One lot of HemosIL SynthASil (APTT) (K953981) reagent spiked with graduated quantities of unfractionated heparin and tested. The data demonstrates a heparin response on the act top to 0.8 U/mL.

A Replacement Reagent Protocol was submitted to include:

Protocols for within run and total precision, method comparison, linearity, carryover interference, stability, target medical decision levels.

F. Conclusion:

Based on acceptable performance, this device is found substantially equivalent to the predicate device (ACL Advance K002400).