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

Intended 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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KQ33414

JAN 1 2 2004

# Section 3 ACL TOP - 510(k) Summary (Summary of Safety and Effectiveness)

#### Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: [phone] Fax:

#### Contact Person:

Carol Marble, Regulatory Affairs Director Phone: [phone] / Fax: [phone]

#### Summary Prepared:

October 24, 2003

#### Name of the Device:

ACL TOP

#### Classification Name(s):

| 81GKP<br>864.5400 | Instrument, Coagulation, Automated<br>Coagulation Instrument | Class II |
|-------------------|---------------------------------------------------------------------------------------------------------------|----------|
| 81JPA<br>864.5425 | System, Multipurpose for In Vitro Coagulation Studies<br>Multipurpose system for In Vitro Coagulation Studies | Class II |

#### Identification of predicate device(s):

K002400 ACL Advance

#### Description of the device/intended use(s):

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.

#### Statement of Technological Characteristics of the Device Compared to Predicate Device:

The ACL TOP is substantially equivalent in performance, intended use, safety and effectiveness to the ACL Advance (predicate device) for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.

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# Section 3 (Cont.) ACL TOP - 510(k) Summary (Summary of Safety and Effectiveness)

#### Summary of Performance Data:

#### Precision

Within run and total precision assessed over multiple runs (n=80) using normal and abnormal levels of control plasma gave the following results:

| Reagent Type | Control Level | Mean | Within Run<br>%CV | Total<br>%CV |
|------------------------------------|----------------|-------|-------------------|--------------|
| Antithrombin<br>(%) | Normal | 108.5 | 5.7 | 5.8 |
| | Low Abnormal | 53.5 | 5.6 | 6.8 |
| | High Abnormal | 32.0 | 6.8 | 9.1 |
| APTT<br>(Seconds) | Normal | 30.3 | 1.2 | 1.6 |
| | Low Abnormal | 49.3 | 0.9 | 2.1 |
| | High Abnormal | 59.0 | 0.9 | 1.4 |
| D-Dimer<br>(ng/mL) | Low Control | 340 | 4.6 | 7.7 |
| | High Control | 729 | 2.5 | 4.5 |
| Factor II<br>(%) | Normal | 110.7 | 4.2 | 5.2 |
| | Low Abnormal | 64.5 | 4.1 | 5.3 |
| | High Abnormal | 37.5 | 3.8 | 5.6 |
| Factor V<br>(%) | Normal | 124.7 | 4.0 | 4.7 |
| | Low Abnormal | 79.9 | 3.0 | 4.7 |
| | High Abnormal | 43.4 | 3.6 | 4.8 |
| Factor VII<br>(%) | Normal | 106.2 | 3.6 | 3.9 |
| | Low Abnormal | 61.3 | 2.1 | 3.7 |
| | High Abnormal | 33.0 | 2.9 | 4.4 |
| Factor X<br>(%) | Normal | 114.6 | 1.8 | 2.8 |
| | Low Abnormal | 64.6 | 2.2 | 3.4 |
| | High Abnormal | 38.3 | 1.9 | 3.6 |
| Fibrinogen-C<br>(mg/dL) | Normal | 364.7 | 7.9 | 8.8 |
| | Low Fibrinogen | 92.9 | 7.7 | 8.4 |
| Protein C<br>(%) | Normal | 120.4 | 2.6 | 3.3 |
| | Low Abnormal | 30.9 | 3.0 | 4.3 |
| | High Abnormal | 18.4 | 3.7 | 4.7 |
| Prothrombin Time (PT)<br>(Seconds) | Normal | 11.9 | 1.3 | 1.4 |
| | Low Abnormal | 25.7 | 1.5 | 2.7 |
| | High Abnormal | 37.3 | 1.8 | 3.0 |
| PT-Based Fibrinogen<br>(mg/dL) | Normal | 302.6 | 3.7 | 4.1 |
| | Low Fibrinogen | 128.2 | 7.7 | 7.8 |

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# Section 3 (Cont.) ACL TOP - 510(k) Summary (Summary of Safety and Effectiveness)

## Summary of in-house performance data (Cont.):

#### Method Comparison

In method comparison studies evaluating citrated plasma samples, the ACL TOP and the ACL Advance (predicate device) were shown to be statistically similar as shown below.

| Reagent Type | n | Slope | Intercept | r | Sample Range |
|------------------------------------|-----|-------|-----------|--------|----------------|
| Antithrombin<br>(%) | 123 | 1.03 | -1.418 | 0.9660 | 25.0 to 121.7 |
| APTT<br>(Seconds) | 205 | 1.076 | -0.380 | 0.9943 | 24.2 to 236.7 |
| D-Dimer<br>(ng/mL) | 120 | 1.12 | -16.0 | 0.993 | 84 to 19809 |
| Factor II<br>(%) | 101 | 0.95 | -0.551 | 0.9753 | 6.0 to 128.2 |
| Factor V<br>(%) | 93 | 0.81 | 4.742 | 0.9822 | 2.1 to 149.3 |
| Factor VII<br>(%) | 96 | 0.88 | 3.153 | 0.9922 | 6.3 to 147.4 |
| Factor X<br>(%) | 110 | 0.97 | 2.995 | 0.9954 | 5.0 to 142.3 |
| Fibrinogen-C<br>(mg/dL) | 98 | 1.00 | -8.740 | 0.9759 | 121.6 to 695.0 |
| Protein C<br>(%) | 123 | 1.15 | -0.323 | 0.9902 | 9.4 to 129.7 |
| Prothrombin Time (PT)<br>(Seconds) | 150 | 0.990 | 1.46 | 0.9987 | 9.8 to 107.4 |
| PT-Based Fibrinogen<br>(mg/dL) | 93 | 1.084 | -9.93 | 0.9587 | 121.6 to 695.0 |

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# Indications for Use Statement

510(k) Number (if known): k033414

Device Name: ACL TOP

## 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.

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.019) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Section 2

ACL TOP Abbreviated 510(k)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 2 2004

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

k033414 Re: Trade/Device Name: ACL TOP Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation instrument Regulatory Class: Class II Product Code: GKP Dated: October 24, 2003 Received: October 27, 2003

Dear Ms. Marble:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device it into of our of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may outlish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act than a Dederal statutes and regulations administered by other Federal agencies. You must or unry vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number (if known): K033414

Device Name: ACL TOP

## 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033414

Prescription Use
(Per 21 CFR 801.019)

OR

Over-The-Counter Use _

Section 2

ACL TOP Abbreviated 510(k)

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