HEMOSIL SYNTHASIL

K060688 · Instrumentation Laboratory CO · GFO · Apr 13, 2006 · Hematology

Device Facts

• Record ID: K060688
• Device Name: HEMOSIL SYNTHASIL
• Applicant: Instrumentation Laboratory CO
• Product Code: GFO · Hematology
• Decision Date: Apr 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7925
• Device Class: Class 2

Intended Use

The HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems

Device Story

HemosIL SynthASil is a synthetic phospholipid reagent used for in vitro diagnostic testing of human citrated plasma. It functions as a reagent in coagulation analyzers (IL Coagulation and ELECTRA Systems) to measure Activated Partial Thromboplastin Time (APTT). The device is used in clinical laboratory settings by trained technicians to evaluate the intrinsic coagulation pathway and monitor heparin therapy. This specific submission optimizes APTT parameter settings on ACL Futura and ACL Advance instruments to improve correlation with the ACL TOP system. The output is a time-based measurement (seconds) representing the clotting time of the plasma sample, which clinicians use to assess coagulation status and adjust anticoagulant therapy.

Clinical Evidence

No clinical data. Bench testing only; sponsor provided risk analysis and Declaration of Conformity with Design Controls confirming development activities and product specifications were met.

Technological Characteristics

Synthetic phospholipid reagent for APTT determination. Designed for use on IL Coagulation and ELECTRA Systems. Optimized for specific instrument parameter settings (ACL Futura and ACL Advance).

Indications for Use

Indicated for in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma. Used for evaluation of intrinsic coagulation pathway, APTT substitution testing, and monitoring of heparin therapy.

Regulatory Classification

Identification

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

Predicate Devices

• HemosIL SynthASil (K953981)

Submission Summary (Full Text)

{0}------------------------------------------------

APR 1 3 2006

K060688

# 510(k) Summary (Summary of Safety and Effectiveness)

## Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

### Contact Person:

Carol Marble, Regulatory Affairs Director Phone No .: 781-861-4467 Fax No .: 781-861-4207

#### Prepared:

March 14, 2006

#### Device Name:

HemosIL SynthASil

#### Regulatory Information:

| Regulation No.: | 864.7925 |
|----------------------|-----------------------------------|
| Classification Name: | Partial Thromboplastin Time Tests |
| Product Code: | GFO |
| Panel: | Hematology |

#### Predicate Device:

K953981 HemosIL SynthASil

#### Device Description:

HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

## Reason for Submission:

The APTT parameter settings for HemosIL SynthASil on the ACL Futura and ACL Advance are being optimized for improved correlation with the ACL TOP, impacting the instrument-specific performance claims in the product insert.

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

The performance of HemosIL SynthASil with optimized APTT parameter settings on the ACL Futura (K951891) and ACL Advance (K002400) is substantially equivalent to the performance of the current legally marketed device on the ACL TOP (K033414).

{1}------------------------------------------------

# 510(k) Summary (Cont.) (Summary of Safety and Effectiveness)

## Summary of Performance Data:

### Within Run Precision

Within run and total precision assessed over multiple runs using three levels of control plasma for APTT gave the following results:

| | Mean (Seconds) | CV% (Within run) | CV% (Total) |
|---------------|----------------|------------------|-------------|
| Normal | 28.5 | 0.6 | 0.6 |
| Low Abnormal | 49.0 | 0.8 | 0.9 |
| High Abnormal | 62.5 | 0.7 | 0.8 |

# Method Comparison

In a method comparison study evaluating citrated plasma samples, the slopes and correlations coefficient (r) are shown below for four different lots of the legally marketed HemosLL SynthASil tested on an ACL Advance with optimized APTT parameters versus on the ACL TOP:

| SynthASil Lot | n | Slope | Intercept | r | Sample Range (Sec.) |
|---------------|----|-------|-----------|--------|---------------------|
| Lot No. A | 93 | 1.011 | -0.664 | 0.9979 | 25.6 - 188.6 |
| Lot No. B | 93 | 0.984 | 0.293 | 0.9987 | 27.0 - 220.1 |
| Lot No. C | 93 | 0.994 | 0.159 | 0.9976 | 25.7 - 228.1 |
| Lot No. D | 92 | 0.973 | 1.260 | 0.9973 | 27.4 - 204.8 |

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The logo is surrounded by the text "U.S. Department of Health & Human Services USA" in a circular pattern.

Re:

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421-3125

> k060688 Trade/Device Name: HemosIL SynthASil Regulation Number: 21 CFR § 864.7925 Regulation Name: Partial Thromboplastin Time Tests Regulatory Class: II Product Code: GFO Dated: March 14, 2006 Received: March 15, 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 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.

APR 1 3 2006

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 can be found in Title 21, Code 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 that FDA has made 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.

{3}------------------------------------------------

Page 2 -

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/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: HemosIL SynthASil -- Optimized Parameter Settings on the ACL Futura/ACL Advance

# Indications for Use:

HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 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)

Josephine Bruntidin
Director of Staff

Office of In Vitro Diagnostic Device Evaluation and Safety

K060688