ACL ELITE; ACL ELITE PRO

K060162 · Instrumentation Laboratory CO · JPA · Feb 21, 2006 · Hematology

Device Facts

• Record ID: K060162
• Device Name: ACL ELITE; ACL ELITE PRO
• Applicant: Instrumentation Laboratory CO
• Product Code: JPA · Hematology
• Decision Date: Feb 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

The ACL Elite/ Elite Pro are fully automated, high-productivity analyzers 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 systems provide results for both direct hemostasis measurements and calculated parameters.

Device Story

ACL Elite/Elite Pro are fully automated, microcentrifugal analyzers for hemostasis laboratories; operated by clinical staff via touch screen, keyboard, or mouse. System accepts patient samples in 20-cuvette polystyrene rotors; uses rapid acceleration/braking for mixing; performs photometer-based data acquisition at 37°C. Device performs coagulometric, absorbance, and immunological tests. Software modification addresses discrepancies between primary and secondary algorithms for PT and APTT assays; system now reports results from the secondary algorithm when discrepancies occur. Output includes test results displayed on LCD, printed, or sent to host computer. Automated features include calibration, quality control management, and STAT sample processing. Benefits include high-productivity, automated coagulation testing to support clinical assessment of thrombosis and hemostasis.

Clinical Evidence

Bench testing only. Precision assessed over multiple runs using control plasmas for factors, APTT, PT, and fibrinogen; results showed low within-run and total %CV. Method comparison studies (n=47-54) against the ACL 9000 predicate demonstrated statistical similarity across all tested parameters (FVIII, FIX, APTT, PT, Fibrinogen) with high correlation coefficients (r=0.9848 to 0.9993) and slopes near 1.0.

Technological Characteristics

Fully automated, high-productivity in vitro diagnostic analyzer. Employs coagulation and fibrinolysis measurement principles. Features include revised secondary algorithm for PT/APTT, dedicated calibration for HemosIL Factor VIII/IX deficient plasmas, and automated factor parallelism. System is designed for clinical laboratory environment.

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 requiring such diagnostic evaluation.

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 9000 (K000053)

Submission Summary (Full Text)

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

A. 510(k) Number:
K060162

B. Purpose for Submission:
Special submission for a software modification to the PT and APTT test parameters of two new ACL 9000 family members- the ACL Elite and ACL Elite Pro.

C. Manufacturer and Instrument Name:
Instrumentation Laboratory ACL Elite and ACL Elite Pro

D. Type of Test or Tests Performed:
Coagulometric tests (PT-FIB, APTT, TT, Single Factors)
Absorbance Tests (Antithrombin, Heparin, Protein C, Plasmin Inhibitor, Plasminogen Fibrinogen C –Clauss method)
Immunological Tests (D-Dimer, free Protein S, von Willebrand Factor-Activity and Antigen)
Special Tests (Protein S, Factor V Leiden, LAC Screen and Confirm, ProClot C-clotting Protein C)

E. System Descriptions:
1. Device Description: The ACL is a family of fully automated computer-controlled, microcentrifugal analyzers. The ACL Elite/Elite Pro system incorporates a liquid crystal display (LCD) unit that shows the status of the instrument, permits the user to select desired procedures, and through the use of menus and options guides the operator through these procedures. Information and instructions are entered into the system either via a touch screen device or through a standard PC keyboard or mouse.
2. Principles of Operation:
When sample testing is initiated, the samples and reagents are sequentially pipetted into a 20-cuvette polystyrene rotor (loading process). A centrifugation process then mixes sample and reagents. The mixing is carried out by a combination or rapid acceleration and braking actions, which are effective in

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thoroughly mixing the liquids. Reaction measurements (data acquisition) via the photometer are made while the rotor is spinning.

The ACL measures the parameters at $37^{\circ}\mathrm{C} \pm 1^{\circ}\mathrm{C}$, at ambient temperature from $15^{\circ}\mathrm{C}$ to $32^{\circ}\mathrm{C}$. However, if the ACL is in a temperature-controlled environment where temperature is held constant, the measurements are made within a narrower temperature range: $37^{\circ}\mathrm{C} \pm 0.25^{\circ}\mathrm{C}$.

The results are displayed on the LCD and optionally printed by the external printer, and/or sent to a host computer. The ACL performs automatic calibration, offers a series of utility programs for the operator and manages a complete quality control program.

3. Modes of Operation:

The user may program single or multiple tests on patient samples to be performed on a random access basis. Users also have the capability to pause the system during an analytical session for STAT samples.

4. Specimen Identification:

On-board an external barcode reader, manual entry.

5. Specimen Sampling and Handling:

Samples are collected, centrifuged, and loaded onto one of three different sample trays. The ACL contains an autosampler system that pipettes samples and reagents into the loading and analysis area.

6. Calibration:

When required, the ACL Elite/Elite Pro prompts the user to perform a calibration. Calibration is performed with commercially available calibration material either prior to or simultaneously with sample analysis.

7. Quality Control:

Commercial quality control material is available for daily monitoring of the instrument.

8. Software:

FDA has reviewed applicant's Hazard Analysis and Software Development processes for this line of product types:

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Yes ☐ X or No ☐

## F. Regulatory Information:

1. Regulation section:
21 CRF 864.5425

2. Classification:
II

3. Product code:
JPA

4. Panel:
81 Hematology

## G. Intended Use:

1. Indication(s) for Use:
The ACL Elite/ Elite Pro are fully automated, high-productivity analyzers 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 systems provide results for both direct hemostasis measurements and calculated parameters.

2. Special Conditions for Use Statement(s):

## H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:
K000053 ACL 9000 (ACL 8000 and ACL 10000)

2. Comparison with Predicate Device:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | in vitro diagnostic clinical use in the | same |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. | |
| Test parameters | PT-FIB, APTT, TT, Single Factors, Antithrombin, Heparin, Protein C, Plasmin Inhibitor, Plasminogen Fibrinogen C -Clauss method, D-Dimer, free Protein S, von Willebrand Factor-Activity and Antigen, Protein S, Factor V Leiden, LAC Screen and Confirm, ProClot C-clotting Protein C | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Software modification for PT and APTT assays- Clot time from the Primary Algorithm is discrepant from the value determined with the Secondary algorithm | Reports results from secondary algorithm | Discrepancies between the primary and secondary algorithm flagged with a “Noisy baseline” warning |

# I. Special Control/Guidance Document Referenced (if applicable):

# J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

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Site 1

| Reagent | n | Slope | Intercept | r | Sample Range |
| --- | --- | --- | --- | --- | --- |
| HemosIL APTT-SP (seconds) | 54 | 1.032 | -1.30 | 0.9990 | 26.5-95.4 |
| HemosIL SynthASil (seconds) | 52 | 1.009 | 0.02 | 0.9981 | 9.7-80.4 |
| HemosIL PT-Fib Recombinant PT (Seconds) | 49 | 0.972 | 0.50 | 0.9993 | 10.8-44.7 |
| HemosIL PT-Fib Recombinant Fibrinogen (mg/dl) | 47 | 0.974 | 0.4 | 0.9992 | 133-808 |
| HemosIL PT-Fibrinogen PT (seconds) | 49 | 0.989 | 0.35 | 0.9985 | 11.3-21.2 |
| HemosIL PT-Fibrinogen Fibrinogen (mg/dl) | 47 | 0.996 | -16.3 | 0.9848 | 141-869 |
| HemosIL Factor VIII (% Activity) | 47 | 0.909 | 1.549 | 0.9938 | 1.1-147 |
| HemosIL Factor IX (% Activity) | 49 | 0.948 | 1.47 | 0.9914 | 5.5-149 |

Site 2

| Reagent | N | Slope | Intercept | R | Sample Range |
| --- | --- | --- | --- | --- | --- |
| HemosIL SynthASil (seconds) | 72 | 0.988 | -0.69 | 0.9756 | 24.7-60.3 |
| HemosIL PT-Fibrinogen PT (seconds) | 72 | 0.981 | 0.40 | 0.9944 | 11.4-47.1 |
| HemosIL PT-Fibrinogen Fibrinogen (mg/dl) | 58 | 1.013 | 18.1 | 0.9846 | 154-1204 |
| HemosIL Liquid Antithrombin (% Activity) | 55 | 1.074 | 1.04 | 0.9616 | 22.7-123.0 |
| HemosIL Fibrinogen-C (mg/dl) | 47 | 0.960 | 16.0 | 0.9585 | 119-698 |
| HemosIL Thrombin Time (% Activity) | 58 | 0.961 | 0.44 | 0.9836 | 9.0-35.2 |
| HemosIL Factor VIII (% Activity) | 49 | 1.198 | -7.22 | 0.9909 | 2.8-149.0 |
| HemosIL Factor IX (% Activity) | 56 | 0.929 | -6.12 | 0.9956 | 4.5-150.0 |
| HemosIL Factor XII (% Activity) | 51 | 1.054 | -5.91 | 0,9943 | 7.5-135.0 |
| HemosIL D-Dimer (% Activity) | 63 | 1.263 | -64.84 | 0.9887 | 86.9-3472 |

b. Precision/Reproducibility:

APTT (Seconds)

HemosIL APTT-SP (K973306)

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| | N | Mean | With-in Run | Total |
| --- | --- | --- | --- | --- |
| | | | %CV | %CV |
| Normal Control | 50 | 29.3 | 1.1 | 2.0 |
| Low Abnormal Control | 50 | 46.1 | 1.9 | 4.1 |
| High Abnormal Control | 50 | 56.9 | 2.2 | 4.7 |

HemosIL SynthASil (APTT) (K953981)

| | N | Mean | With-in Run | Total |
| --- | --- | --- | --- | --- |
| | | | %CV | %CV |
| Normal Control | 50 | 29.0 | 0.8 | 1.8 |
| Low Abnormal Control | 50 | 51.9 | 1.0 | 1.5 |
| High Abnormal Control | 50 | 60.5 | 1.2 | 1.2 |

PT (Seconds)

HemosIL PT-Fibrinogen Recombinant (K981479)

| | N | Mean | With-in Run | Total |
| --- | --- | --- | --- | --- |
| | | | %CV | %CV |
| Normal Control | 50 | 10.7 | 1.0 | 1.1 |
| Low Abnormal Control | 50 | 35.0 | 1.1 | 2.0 |
| High Abnormal Control | 50 | 51.6 | 1.4 | 3.4 |

HemosIL PT-Fibrinogen (K862301)

| | N | Mean | With-in Run | Total |
| --- | --- | --- | --- | --- |
| | | | %CV | %CV |
| Normal Control | 50 | 12.3 | 0.6 | 1.1 |
| Low Abnormal Control | 50 | 20.7 | 0.9 | 1.1 |
| High Abnormal Control | 50 | 25.5 | 0.8 | 1.4 |

Fibrinogen (mg/dL)

HemosIL PT-Fibrinogen Recombinant (K981479)

| | N | Mean | With-in Run | Total |
| --- | --- | --- | --- | --- |
| | | | %CV | %CV |
| Normal Control | 50 | 297.6 | 3.8 | 6.7 |
| Low Abnormal Control | 50 | 113.1 | 5.3 | 6.4 |

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HemosIL PT-Fibrinogen (K862301)

| | N | Mean | With-in Run
%CV | Total
%CV |
| --- | --- | --- | --- | --- |
| Normal Control | 50 | 277.9 | 4.4 | 4.6 |
| Low Abnormal Control | 50 | 132.9 | 3.6 | 5.5 |

Factor VIII (% Activity)

HemosIL Factor VIII (K034007) with APTT-SP

| | N | Mean | With-in Run
%CV | Total
%CV |
| --- | --- | --- | --- | --- |
| Normal Control | 50 | 85.3 | 4.1 | 4.5 |
| Special Test Control Level 1 | 50 | 72.4 | 2.9 | 3.6 |
| Special Test Control Level 2 | 50 | 36.3 | 4.6 | 5.4 |

HemosIL Factor IX (K031829) with APTT-SP

| | N | Mean | With-in Run
%CV | Total
%CV |
| --- | --- | --- | --- | --- |
| Normal Control | 50 | 115.6 | 2.7 | 5.2 |
| Special Test Control Level 1 | 50 | 76.2 | 2.3 | 4.5 |
| Special Test Control Level 2 | 50 | 41.0 | 3.3 | 5.1 |

c. Linearity:

d. Carryover:

e. Interfering Substances:

2. Other Supportive Instrument Performance Data Not Covered Above:

An additional study was conducted to support the use of the Secondary Algorithm

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on the ACL Elite/Elite Pro to report unflagged results in the specific case where there is a discrepancy between the Primary and Secondary Algorithms. The data is summarized below:

| | APTT-SP (Seconds) | | SynthASIL (Seconds) | | PT FIB | | PT Recombinant | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Primary | Secondary | Primary | Secondary | Primary | Secondary | Primary | Secondary |
| Mean | 33.6 | 33.8 | 32.7 | 32.8 | 14.4 | 14.4 | 17.8 | 18.1 |

As required for a Special 510(k), the Sponsor has provided a risk analysis as well as a Declaration of Conformity with Design Controls indicating that development activities were conducted under appropriate design controls procedures, and the overall product specifications were met.

# K. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

# L. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.