HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)

K021022 · Instrumentation Laboratory CO · GGN · May 14, 2002 · Hematology

Device Facts

• Record ID: K021022
• Device Name: HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)
• Applicant: Instrumentation Laboratory CO
• Product Code: GGN · Hematology
• Decision Date: May 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

HemosIL Low Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the low abnormal range on IL Coagulation and ELECTRA™ Systems. The Low Abnormal Control is prepared from 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 Low Abnormal Control ASSAYED is an in vitro diagnostic control material used to monitor the performance of coagulation assays on IL Coagulation and ELECTRA systems. The device consists of human citrated plasma from healthy donors, modified to simulate an abnormal coagulation state. It is used by laboratory professionals in clinical settings to verify the accuracy and precision of test results for analytes including PT, APTT, Antithrombin, Protein C, Protein S, and Thrombin Time. By providing a known low abnormal value, the control allows clinicians to validate that the analytical system is functioning correctly within the expected range, ensuring reliable diagnostic testing for patients.

Clinical Evidence

Bench testing only. Precision study performed over multiple days and runs (n=80 for most analytes, n=40 for Protein S). Results demonstrated within-run %CVs: APTT 1.84%, Antithrombin 5.60%, Protein C 5.96%, Protein S 2.31%, PT 1.15%, and Thrombin Time 4.00%.

Technological Characteristics

Human citrated plasma-based control; modified to simulate low abnormal coagulation levels. Designed for use on IL Coagulation and ELECTRA systems. No specific materials of construction or software algorithms described; functions as a chemical/biological reference standard.

Indications for Use

Indicated for quality control of coagulation assays in the low abnormal range on IL Coagulation and ELECTRA systems. Prepared from human citrated plasma from healthy donors; not for use with heparinized plasma or samples from patients on 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™ Low Abnormal Control (K931117)
• IL Test™ Abnormal Chromogenic Control Plasma Level 1 (K864271)
• IL Test™ Protein C Control Plasma (K912711)
• IL Test™ Protein S Control Plasma (K930327)
• ThromboScreen Abnormal Thrombin Time Control (K000679)

Submission Summary (Full Text)

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MAY 1 4 2002

K021022

## Section 3 HemosIL Low 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 Low Abnormal Control ASSAYED

### 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 |
|------------|----------------------------------------------------------------------------|--------------------------------------------|
| K931117 | Assess™ Low Abnormal Control | Prothrombin Time (PT) |
| | | Activated Partial<br>Thromboplastin (APTT) |
| K864271 | IL Test™ Abnormal Chromogenic Control Plasma<br>Level 1 | 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 |
| K000679 | ThromboScreen Abnormal Thrombin Time Control | Thrombin Time |

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

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

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

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

Section 3

HemosIL Low Abnormal Control 510(k)

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

## Summary of Performance Data:

A precision study was performed with HemosIL Low 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 | 42.4 | 1.84 |
| Antithrombin<br>(% Activity) | 80 | 35.4 | 5.60 |
| Protein C<br>(% Activity) | 80 | 28.7 | 5.96 |
| Protein S<br>(% Activity) | 40 | 40.2 | 2.31 |
| Prothrombin Time (PT)*<br>(Seconds) | 80 | 23.5 | 1.15 |
| Thrombin Time<br>(Seconds) | 80 | 20.0 | 4.00 |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's head is facing left, and its wings are represented by curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAY 1 4 2002

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

Re: k021022

> Trade/Device Name: HemosIL Low Abnormal Control ASSAYED 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 nredicate 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

621022 510(k) Number (if known):

HemosIL Low Abnormal Control ASSAYED Device Names:

### Indications for Use:

HemosIL Low Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the low abnormal range on IL Coagulation and ELECTRA™ Systems. The Low Abnormal Control is prepared from 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 low 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 | K021022 |
| Prescription Use (Per 21 CFR 801.019) | OR Over-The-Counter Use |

HemosIL Low Abnormal Control 510(k)