HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2

K040359 · Instrumentation Laboratory CO · JPA · Mar 19, 2004 · Hematology

Device Facts

• Record ID: K040359
• Device Name: HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
• Applicant: Instrumentation Laboratory CO
• Product Code: JPA · Hematology
• Decision Date: Mar 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The intended use to HemosIL Special Test Controls Level 1 & 2 is being expanded with the addition of value assignments for chromogenic Factor VIII tests (Levels 1 and 2) and clotting factor assays (Level 2 only). There are no changes in product formulation or alterations in the fundamental scientific technology introduced with the new value assignments. HemosIL Special Test Controls Level 1 & 2 is labeled: - For the quality control in the abnormal range of the chromogenic tests (Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C and Factor VIII) and Free Protein S assay performed on the IL Coagulation Systems. - For the Quality Control of von Willebrand Factor assay in the normal (Level 1) and abnormal range (Level 2) on the IL Coagulation Systems. - For the Quality Control of factor assays (clotting) in the abnormal range (Level 2) on the IL Coagulation Systems.

Device Story

Lyophilized human plasma control; contains buffer and stabilizers; used for quality control of coagulation assays on IL Coagulation Systems; assesses precision and accuracy of chromogenic, clotting, and protein assays; provides abnormal range values for monitoring patient testing; used in clinical laboratory settings by laboratory personnel; ensures reliability of diagnostic results for patients undergoing thrombolytic therapy or coagulation testing.

Clinical Evidence

No clinical data. Bench testing only. Performance established via traceability to WHO International Standards (e.g., 94/746, 97/586) and internal house standards for parameters lacking international references. Precision and accuracy assessed via multiple runs on IL Coagulation Systems.

Technological Characteristics

Lyophilized human plasma; contains buffer and stabilizers. Designed for use on IL Coagulation Systems. Traceable to WHO International Standards or internal house standards. No electronic or software components.

Indications for Use

Indicated for use as a quality control material for human plasma-based coagulation assays, including chromogenic tests (Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C, Factor VIII), Free Protein S, von Willebrand Factor, and clotting factor assays on IL Coagulation Systems.

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

• HemosIL Special Test Controls Level 1 & 2 (K864271)

Submission Summary (Full Text)

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MAR 1 9 2004

K040359

### Section 3

# 510(k) Summary (Summary of Safety and Effectiveness) HemosIL Special Test Controls Level 1 & 2: Expanded Indications for Use

#### Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421

#### Contact Person:

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

Summary Prepared:

February 12, 2003

#### Name of the Device:

HemosIL Special Test Controls Level 1 & 2 (Expansion of Indications to for Use)

#### Classification Name:

| 864.5425 | Multipurpose System for In Vitro Coagulation Studies | Class II |
|----------|-------------------------------------------------------|----------|
| JPA | System, Multipurpose for In Vitro Coagulation Studies | |

#### Identification of predicate device:

K864271 HemosIL Special Test Controls Level 1 & 2

### Description of the Device with Expanded Indications for Use:

The intended use to HemosIL Special Test Controls Level 1 & 2 is being expanded with the addition of value assignments for chromogenic Factor VIII tests (Levels 1 and 2) and clotting factor assays (Level 2 only). There are no changes in product formulation or alterations in the fundamental scientific technology introduced with the new value assignments.

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

HemosIL Special Test Controls Level 1 & 2 with the expanded intended use due to the new value assignments is substantially equivalent to the current legally marketed product (K864271).

### Summary of Performance Data:

- Chromogenic Factor VIII: .

| Reagent | Instrument | Level | Mean (%)<br>n=32 | Within-Run<br>%CV |
|------------------------------|------------|---------|------------------|-------------------|
| ELECTRACHROME<br>Factor VIII | ACL 9000 | Level 1 | 67.5 | 3.30 |
| | | Level 2 | 37.9 | 3.53 |

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## Section 3 (Cont.)

# 510(k) Summary (Summary of Safety and Effectiveness) HemosIL Special Test Controls Level 1 & 2: Expanded Indications for Use

## Summary of Performance Data (Cont.):

#### . Factor Assays (Clotting):

| Reagent | Instrument | Mean (%)<br>n=32 | Within-Run<br>%CV |
|---------------------|------------------------|------------------|-------------------|
| HemosIL Factor II | ACL Classic | 33.0 | 4.31 |
| | ACL Futura/ACL Advance | 30.8 | 8.77 |
| Deficient Plasma | ACL 9000 | 34.1 | 3.16 |
| HemosIL Factor V | ACL Classic | 33.6 | 2.50 |
| | ACL Futura/ACL Advance | 37.1 | 3.15 |
| Deficient Plasma | ACL 9000 | 36.5 | 2.27 |
| HemosIL Factor VII | ACL Classic | 30.5 | 3.09 |
| | ACL Futura/ACL Advance | 34.8 | 6.76 |
| Deficient Plasma | ACL 9000 | 33.1 | 3.53 |
| HemosIL Factor VIII | ACL Classic | 33.7 | 5.54 |
| | ACL Futura/ACL Advance | 36.1 | 5.52 |
| Deficient Plasma | ACL 9000 | 32.4 | 6.93 |
| HemosIL Factor IX | ACL Classic | 34.8 | 3.23 |
| | ACL Futura/ACL Advance | 34.1 | 10.07 |
| Deficient Plasma | ACL 9000 | 34.2 | 7.45 |
| HemosIL Factor X | ACL Classic | 31.6 | 1.65 |
| | ACL Futura/ACL Advance | 32.8 | 2.12 |
| Deficient Plasma | ACL 9000 | 34.3 | 2.13 |
| HemosIL Factor XI | ACL Classic | 28.5 | 2.99 |
| | ACL Futura/ACL Advance | 30.0 | 13.24 |
| Deficient Plasma | ACL 9000 | 30.2 | 4.34 |
| HemosIL Factor XII | ACL Classic | 34.1 | 7.22 |
| | ACL Futura/ACL Advance | 29.7 | 7.40 |
| Deficient Plasma | ACL 9000 | 34.3 | 2.61 |

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Image /page/2/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.

MAR 1 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k040359

> Trade/Device Name: HemosIL Special Test Controls Level 1 & 2 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: February 12, 2004 Received: February 13, 2004

Dear Mr. 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 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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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,

Joseph L. Hackett

Joseph L. Hackett, Ph.D. Acting 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): K040359

Device Name: HemosIL Special Test Controls Level 1 & 2

#### Indications for Use:

The intended use to HemosIL Special Test Controls Level 1 & 2 is being expanded with the The Intended use to remests openar factor VIII tests (Levels 1 and 2) and cloting factor assays (Level 2 only). There are no changes in product formulation or alterations in the fundamental scientific technology introduced with the new value assignments.

HemosIL Special Test Controls Level 1 & 2 is labeled:

- For the quality control in the abnormal range of the chromogenic tests (Antithrombin, . Plasminogen, Plasmin Inhibitor, Protein C and Factor VIII) and Free Protein S assay performed on the IL Coagulation Systems.
- For the Quality Control of von Willebrand Factor assay in the normal (Level 1) and . abnormal range (Level 2) on the IL Coagulation Systems.
- For the Quality Control of factor assays (clotting) in the abnormal range (Level 2) on the . IL Coagulation Systems.

# (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) | K040359 |
|--------|---------|
|--------|---------|

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