HEMOSIL SILICA CLOTTING TIME

K050221 · Instrumentation Laboratory CO · GFO · Mar 30, 2005 · Hematology

Device Facts

• Record ID: K050221
• Device Name: HEMOSIL SILICA CLOTTING TIME
• Applicant: Instrumentation Laboratory CO
• Product Code: GFO · Hematology
• Decision Date: Mar 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7925
• Device Class: Class 2

Intended Use

HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipids dependent antibodies.

Device Story

In vitro diagnostic assay; detects Lupus Anticoagulants (LA) in human citrated plasma. Uses two liquid reagents: SCT Screen (low phospholipid concentration) and SCT Confirm (high phospholipid concentration); both contain colloidal silica. Includes calcium chloride activator with polybrene to neutralize heparin. Performed on IL Coagulation Systems (ACL Advance, ACL Futura). Principle: LA antibodies interfere with phospholipid-dependent coagulation; high phospholipid concentration in Confirm reagent neutralizes LA effect. Normalized SCT ratio calculated by dividing Screen ratio by Confirm ratio. Ratio >1.24 indicates LA presence. Used in clinical laboratories by technicians; results assist clinicians in diagnosing anti-phospholipid antibody syndrome or related coagulation disorders.

Clinical Evidence

Clinical study of 206 citrated plasma samples (121 normal, 85 abnormal) compared the device to predicate devices on an ACL Futura system. Results showed a relative sensitivity of 92.4% (95% CI: 82.1-97.0) and a relative specificity of 100% (95% CI: 97.6-100.0). All 48 known Lupus Anticoagulant samples tested positive (normalized ratio > 1.24). Precision studies (n=80) demonstrated total %CV ranging from 2.95% to 6.00% across three control levels.

Technological Characteristics

Liquid reagents containing colloidal silica, synthetic phospholipids, buffer, and Tektamer preservative. Activator contains 0.025Mol/L Calcium chloride and polybrene. Clotting-based assay principle. Designed for automated IL Coagulation Systems. Storage at 2-8°C. Complies with NCCLS C28-A2 and EP5-T2 standards.

Indications for Use

Indicated for the detection of Lupus Anticoagulants in human citrated plasma samples. For in vitro diagnostic use by prescription.

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 LAC Screen and HemosIL LAC Confirm (K990302)

Submission Summary (Full Text)

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## Section 3 HemosIL Silica Clotting Time - 510(k) Summary (Summary of Safety and Effectiveness)

### Submitted by:

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

#### Contact Person:

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

### Summary Prepared:

January 28, 2005

### Name of the Device:

HemosIL Silica Clotting Time

### Regulatory Information:

Regulation Section: Partial Thromboplastin Time Tests (864.7925) Classification: Class II Product Code: GFO Panel: Hematology

### Identification of Predicate Device(s):

K990302 HemosIL LAC Screen and HemosIL LAC Confirm

### Description of the Device/Intended Use(s):

HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.

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

The HemosIL Silica Clotting Time is substantially equivalent to the commercially available predicate devices (HemosIL LAC Screen and HemosIL LAC Confirm) in performance and intended use.

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# Section 3 HemosIL Silica Clotting Time - 510(k) Summary (Summary of Safety and Effectiveness)

#### Summary of Performance Data:

### Method Comparison

In an in-house study of 210 citrated plasma samples (120 normals/90 abnormals) on an ACL Advance, comparing HemosIL Silica Clotting Time to the predicate devices, the following correlation data were obtained:

| Unit | slope | intercept | r | Reference method |
|-------------------------|-------|-----------|-------|--------------------|
| Normalized<br>LAC ratio | 1.099 | -0.086 | 0.874 | LAC Screen/Confirm |

In a clinical study of 206 citrated plasma samples (121 normals/85 abnormals), comparing HemosIL Silica Clotting Time (cut-off > 1.24) to the predicate devices (cut-off ≥ 1.20) on an ACL Futura, a relative Sensitivity of 92.4% (95% C.I. = 82.1-97.0) and a relative Specificity of 100% (95% C.I. = 97.6-100.0) were determined. All known Lupus Anticoagulant samples (n=48) tested as part of this study gave SCT normalized ratios > 1.24.

### Within Run Precision

Within run and between run precision was assessed over multiple runs (n=80) using three levels of controls.

| Instrument | Control | Mean<br>Normalized Ratio | Within run<br>%CV | Total<br>%CV |
|-------------|-----------------|--------------------------|-------------------|--------------|
| ACL Advance | Normal Control | 1.05 | 2.47 | 2.95 |
| ACL Advance | Low LA Control | 1.90 | 4.05 | 6.00 |
| ACL Advance | High LA Control | 2.77 | 5.24 | 5.60 |

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of several curved lines that create the impression of feathers or wings.

MAR 3 0 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k050221

> Trade/Device Name: HemosIL Silica Clotting Time Regulation Number: 21 CFR 864.7925 Regulation Name: Partial thromboplastin time tests Regulatory Class: Class II Product Code: GFO Dated: January 28, 2005 Received: January 31, 2005

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.

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).

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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,

Robert Beckerh

Robert L. Becker, Jr., MD, I 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): ____________________________________________________________________________________________________________________________________________________

Device Name: HemosIL Silica Clotting Time

### Indications for Use:

HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.

For in vitro diagnostic use.

Prescription Use
(Part 21 CFR 801 Subpart D)

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)

Josephine Bautista
Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K050221