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

Intended 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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# Section 3 ACL Elite and ACL Elite Pro 510(k) Summary

K060/62

#### Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

### Contact Person:

Carol Marble, Regulatory Affairs Director 781-861-4467 Phone: [phone] Fax:

### Summary Prepared:

January 20, 2006

### Device Name:

ACL Elite and ACL Elite Pro

### Classification Name:

Multipurpose system for in vitro coagulation studies (864.5425) Regulation Section: Classification: Class II JPA Product Code: Hematology Panel:

### Legally Marketed Device:

ACL 9000 (ACL 8000 and ACL 10000) K000053

### Device Description:

The ACL Elite and ACL 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.

The analytical modifications to the ACL 8000/9000/10000 introduced with the new family members (ACL Elite and ACL Elite Pro) include the following:

- Modification to the test parameter (revised use of the Secondary Algorithm) for several . PT and APTT assays.
- Addition of dedicated calibration for HemosIL Factor VIII and HemosIL Factor IX . Deficient Plasmas, when used in conjunction with HemosIL APTT-SP.
- Introduction of automated factor parallelism, which is a manual function on the ACL . 8000/9000/10000.

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# Section 3 (Cont.) ACL Elite and ACL Elite Pro 510(k) Summary

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

The indications for use/intended use, operating principle and performance claims of the ACL Elite and ACL Elite Pro are substantially equivalent to the legally marketed device, the ACL 8000/9000/10000 (K000053).

### Summary of Performance Data:

### Precision

Within run and total precision assessed over multiple runs on the ACL Elite Pro using three levels of control plasma for factors deficient plasmas, APTT and PT, and two levels of control plasmas for fibrinogen gave the following results:

| Test | FVIII (% Activity) | | | | |
|---------------------------------------------------|------------------------------|------|-------|--------------------|--------------|
| HemosIL<br>Factor VIII<br>(K034007)<br>w/ APTT-SP | Material | n | Mean | Within Run<br>% CV | Total<br>%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 | |
| FIX (% Activity) | | | | | |
| HemosIL<br>Factor IX<br>(K031829)<br>w/ APTT-SP | Material | n | Mean | Within Run<br>% CV | Total<br>%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 | |
| APTT (Seconds) | | | | | |
| HemosIL<br>APTT-SP<br>(K973306) | Material | n | Mean | Within Run<br>% CV | Total<br>%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 | |
| APTT (Seconds) | | | | | |
| HemosIL<br>SynthASil<br>(K953981) | Material | n | Mean | Within Run<br>% CV | Total<br>%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 | |

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# Section 3 (Cont.) ACL Elite and ACL Elite Pro 510(k) Summary

### Summary of Performance Data (Cont.):

### Precision (Cont.)

| Test | Prothrombin Time (Seconds) | | | | |
|------------------------------------------------------|----------------------------|----------------------|-------|--------------------|--------------------|
| | Material | n | Mean | Within Run<br>% CV | Total<br>% CV |
| HemosIL<br>PT-Fibrinogen<br>(K862301) | 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) | | | | |
| | Material | n | Mean | Within Run<br>% CV | Total<br>% CV |
| | Normal Control | 50 | 277.9 | 4.4 | 4.6 |
| | Low Fibrinogen Control | 50 | 132.9 | 3.6 | 5.5 |
| HemosIL<br>PT-Fibrinogen<br>Recombinant<br>(K981479) | Prothrombin Time (Seconds) | | | | |
| | | Material | n | Mean | Within Run<br>% CV |
| | | Normal Control | 50 | 10.7 | 1.0 |
| | | Low Abnormal Control | 50 | 35.0 | 1.1 |
| | High Abnormal Control | 50 | 51.6 | 1.4 | 3.4 |
| | Fibrinogen (mg/dL) | | | | |
| | | Material | n | Mean | Within Run<br>% CV |
| | Normal Control | 50 | 297.6 | 3.8 | 6.7 |
| | Low Fibrinogen Control | 50 | 113.1 | 5.3 | 6.4 |

### Method Comparison

In comparison studies evaluating citrated plasma samples, the ACL Elite/ACL Elite Pro versus the ACL 9000 (predicate device) was shown to be statistically similar for the tests listed below:

| Test | Parameter | n | Slope | r |
|---------------------------|---------------------------|----|-------|--------|
| HemosIL Factor VIII | FVIII w/ APTT-SP (% Act.) | 47 | 0.909 | 0.9938 |
| HemosIL Factor IX | FIX with APTT-SP (% Act.) | 49 | 0.948 | 0.9914 |
| HemosIL APTT-SP | APTT (Seconds) | 54 | 1.032 | 0.9990 |
| HemosIL SynthASil | APTT (Seconds) | 52 | 1.009 | 0.9981 |
| HemosIL | PT (sec) | 49 | 0.989 | 0.9985 |
| PT-Fibrinogen | Fibrinogen (mg/dL) | 47 | 0.996 | 0.9848 |
| HemosIL | PT (sec) | 49 | 0.972 | 0.9993 |
| PT-Fibrinogen Recombinant | Fibrinogen (mg/dL) | 47 | 0.974 | 0.9992 |

Special 510(k): ACL Elite and ACL Elite Pro

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect and promote the health and well-being of Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

FEB 2 1 2006

k060162 Re: Trade/Device Name: ACL Elite and ACL Elite Pro Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: JPA Dated: January 20, 2006 Received: January 23, 2006

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 for associated in the 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 r ou mayy atteres, 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 n may or babyer to back of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso o a recer a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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). 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.

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If you desire specific information about the application of labeling requirements to your device, If you destre specific infortion and advertising of your device, please contact the Office of In of quotions on all process Evaluation and Safety at [phone]. Also, please note the vitro Diagnoutied, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may oouall other generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobetz Beckerh

Robert L. Becker, Jr., MD, PK.D Director Division of Immunology and Hematology 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): K060162

Device Name: ACL Elite and ACL Elite Pro

### Indications for Use:

The ACL Elite and ACL 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Jazhine Bautista

Division Sign-off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060162

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