HEMOSIL HIGH ABNORMAL CONTROL ASSAYED

K021024 · Instrumentation Laboratory CO · GGN · May 16, 2002 · Hematology

Device Facts

• Record ID: K021024
• Device Name: HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
• Applicant: Instrumentation Laboratory CO
• Product Code: GGN · Hematology
• Decision Date: May 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

HemosIL High Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the high abnormal range on IL Coagulation and ELECTRA™ Systems. The High Abnormal Control is prepared using human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified to simulate an abnormal coagulation sample.

Device Story

HemosIL High Abnormal Control is a human citrated plasma-based product used for quality control of coagulation assays. It is processed to simulate high abnormal coagulation levels for analytes including PT, APTT, Antithrombin, Protein C, and Protein S. Used in clinical laboratory settings on IL Coagulation and ELECTRA systems. Laboratory technicians use the control to verify the accuracy and precision of coagulation testing platforms. By providing a known high abnormal reference point, the device ensures that coagulation analyzers are performing within expected parameters, thereby supporting reliable clinical decision-making for patients with coagulation disorders.

Clinical Evidence

Bench testing only. Precision study performed over multiple days and runs (n=40 to 80 per analyte). Results: APTT (64.4s, 2.62% CV), Antithrombin (22.8% activity, 9.90% CV), Protein C (14.4% activity, 6.11% CV), Protein S (29.5% activity, 2.75% CV), and PT (43.6s, 1.61% CV).

Technological Characteristics

Human citrated plasma-based control; modified to simulate high abnormal coagulation ranges. Designed for use on IL Coagulation and ELECTRA systems. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for quality control of coagulation assays in the high abnormal range on IL Coagulation and ELECTRA systems. Prepared from human citrated plasma from healthy donors; not for use with heparinized plasma or samples under oral anticoagulant therapy.

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

• Assess™ High Abnormal Control (K931118)
• IL Test™ Abnormal Chromogenic Control Plasma Level 2 (K864271)
• IL Test™ Protein C Control Plasma (K912711)
• IL Test™ Protein S Control Plasma (K930327)

Submission Summary (Full Text)

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K021024

# Section 3

### HemosIL High Abnormal Control - 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 Manager Phone: [phone] / Fax: [phone]

#### Summary Prepared:

March 28, 2002

### Name of the Device(s):

HemosIL High Abnormal Control ASSAYED HemosIL High Abnormal Control 3 UNASSAYED

#### Classification Name(s):

| Common Name: | Plasma Coagulation Control |
|--------------------|----------------------------|
| Product Code: | 81GGN |
| Regulation Number: | 21 CFR 864.5425 |
| Classification: | Class II |

#### Identification of Predicate Device(s):

| 510(k) No. | Predicate Device(s) | Analytes |
|------------|----------------------------------------------------------------------------|---------------------------------------------------------------------|
| K931118 | Assess™ High Abnormal Control | Prothrombin Time (PT)<br>Activated Partial<br>Thromboplastin (APTT) |
| K864271 | IL Test™ Abnormal Chromogenic Control Plasma<br>Level 2 | Antithrombin |
| K912711 | IL Test™ Protein C Control Plasma<br>(component of IL Test™ ProClot kit) | Protein C |
| K930327 | IL Test™ Protein S Control Plasma<br>(component of IL Test™ Protein S kit) | Protein S |

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

Available as an assayed high abnormal control (HemosIL High Abnormal Control) or unassayed high abnormal control (HemosIL High Abnormal Control 3), the product is intended for the quality control of coagulation assays in the high abnormal range on IL Coagulation and ELECTRATM Systems. The High Abnormal Control is prepared using human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to simulate an abnormal coagulation sample.

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

HemosIL High Abnormal Control is substantially equivalent to the predicate devices in performance, intended use and safety and effectiveness for the specific claimed analyte.

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# Section 3 (Cont.) HemosIL High Abnormal Control - 510(k) Summary (Summary of Safety and Effectiveness)

# Summary of Performance Data:

A precision study was performed with HemosIL High Abnormal Control over multiple days with multiple runs using specific lots of reagents and control:

| Analyte | n= | Mean | Within-Run<br>%CV |
|------------------------------------------------------|----|------|-------------------|
| Activated Partial Thromboplastin (APTT)<br>(Seconds) | 80 | 64.4 | 2.62 |
| Antithrombin<br>(% Activity) | 80 | 22.8 | 9.90 |
| Protein C<br>(% Activity) | 80 | 14.4 | 6.11 |
| Protein S<br>(% Activity) | 40 | 29.5 | 2.75 |
| Prothrombin Time (PT)<br>(Seconds) | 80 | 43.6 | 1.61 |

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 6 2002

Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125

Re: k021024

> Trade/Device Name: HemosIL High Abnormal Control ASSAYED HemosIL High Abnormal Control 3 UNASSAYED Regulation Number: 21 CFR § 864.5425 Regulation Name: Plasma, Coagulation Control Regulatory Class: II Product Code: GGN Dated: March 28, 2002 Received: March 29, 2002

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 can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

8021024 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Names: HemosIL High Abnormal Control ASSAYED

### Indications for Use:

HemosIL High Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the high abnormal range on IL Coagulation and ELECTRA™ Systems. The High Abnormal Control is prepared using human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified to simulate an abnormal coagulation sample.

Values for all analytes are in the high abnormal range.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K021024 |

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

HemosIL High Abnormal Control 510(k)