HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)

K021023 · Instrumentation Laboratory CO · GGN · May 14, 2002 · Hematology

Device Facts

• Record ID: K021023
• Device Name: HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (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 Normal Control ASSAYED is intended for the quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ Systems. The normal control is prepared using human citrated plasma from healthy donors.

Device Story

HemosIL Normal Control ASSAYED is an in vitro diagnostic control material consisting of human citrated plasma from healthy donors. It is used in clinical laboratories to monitor the performance and accuracy of coagulation assays within the normal range on IL Coagulation and ELECTRA™ systems. The control provides expected values for various coagulation analytes, including APTT, Antithrombin, Factor V, Factor VIII, Fibrinogen, Plasmin Inhibitor, Plasminogen, Protein C, Protein S, PT, and Thrombin Time. Laboratory personnel use the control to verify that the analytical system is operating within established parameters, ensuring reliable patient test results.

Clinical Evidence

Bench testing only. Precision study performed over multiple days with multiple runs (n=80 for most analytes, n=40 for others) on IL instrumentation. Results demonstrated within-run %CV ranging from 1.05% to 6.36% across 12 coagulation analytes, confirming performance within expected normal ranges.

Technological Characteristics

Human citrated plasma-based control. Liquid/frozen form factor. Designed for use on IL Coagulation and ELECTRA™ systems. No specific materials standards or software algorithms described; device functions as a biological reference material for analytical calibration/verification.

Indications for Use

Indicated for quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ systems. Used for clinical laboratory monitoring of coagulation testing performance.

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™ Normal Control (K002400)

Submission Summary (Full Text)

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K021023

# Section 3 HemosIL Normal Control - 510(k) Summary (Summary of Safety and Effectiveness)

### Submitted by:

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

### Contact Person:

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

### Summary Prepared:

March 28, 2002

#### Name of the Device(s):

HemosIL Normal 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):

K002400 Assess™ Normal Control NOTE: Control was 510(k) cleared as part of analyzer systems, most recently the ACL Advance.

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

HemosIL Normal Control ASSAYED is intended for the quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ Systems. The normal control is prepared using human citrated plasma from healthy donors.

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

HemosIL Normal Control is substantially equivalent to the predicate device in performance, intended use and safety and effectiveness.

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

# Summary of Performance Data:

A precision study was performed with HemosIL Normal Control over multiple days with multiple runs using specific lots of IL reagents on IL instrumentation:

| Analyte | n= | Mean<br>(n=80) | Within-Run<br>%CV |
|------------------------------------------------------|----|----------------|-------------------|
| Activated Partial Thromboplastin (APTT)<br>(Seconds) | 80 | 28.0 | 1.87 |
| Antithrombin<br>(% Activity) | 80 | 110 | 2.10 |
| Factor V (Extrinsic)<br>(% Activity) | 80 | 96.4 | 4.47 |
| Factor VIII (Intrinsic)<br>(% Activity) | 80 | 89.6 | 6.36 |
| Fibrinogen - Clauss<br>(mg/dL) | 80 | 400 | 2.79 |
| Fibrinogen - PT-Based<br>(mg/dL) | 80 | 329 | 4.62 |
| Plasmin Inhibitor<br>(% Activity) | 40 | 99 | 1.05 |
| Plasminogen<br>(% Activity) | 40 | 109 | 1.38 |
| Protein C<br>(% Activity) | 80 | 114 | 2.98 |
| Protein S<br>(% Activity) | 40 | 97.8 | 1.84 |
| Prothrombin Time (PT)<br>(Seconds) | 80 | 10.1 | 1.58 |
| Thrombin Time<br>(Seconds) | 80 | 13.0 | 1.54 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k021023

Trade/Device Name: HemosIL Normal 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 for associated in the encreations of 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 11 Jour de 100 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 r reaso o ac noved 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 or any 1 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

HemosIL Normal Control ASSAYED Device Names:

## Indications for Use:

HemosIL Normal Control ASSAYED is intended for the quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ Systems. The normal control is prepared using human citrated plasma from healthy donors.

Values for all analytes are within the normal range.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | <div> <img alt="signature" src="..."/> <p>(Division Sign-Off)</p> </div> | |
|--------------------------------------------------------|--------------------------------------------------------------------------|----------------------|
| Division of Clinical Laboratory Devices | | |
| 510(k) Number | K021023 | |
| Prescription Use<br>(Per 21 CFR 801.019) | OR | Over-The-Counter Use |

Section 2 HemosIL Normal Control 510(k) Page 1 of 1