I-STAT COAGULATION CONTROL SET

K981752 · Biopool Intl., Inc. · GGN · Jun 15, 1998 · Hematology

Device Facts

• Record ID: K981752
• Device Name: I-STAT COAGULATION CONTROL SET
• Applicant: Biopool Intl., Inc.
• Product Code: GGN · Hematology
• Decision Date: Jun 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The i-STAT Activated Partial Thromboplastin (aPTT), Prothrombine Time (PT), and Activated Clotting Time (ACT) Controls are intended to be used with the i-STAT portable Clinical Analyzer and i-STAT aPTT, PT, and ACT test cartridges to provide a method for verifying the integrity of newly received cartridges. The controls produce clotting times within normal ranges and abnormal ranges to indicate that the test cartridges are functioning properly.

Device Story

i-STAT Coagulation Control Set functions as quality control material for i-STAT portable Clinical Analyzer and test cartridges (aPTT, PT, ACT). Controls consist of samples with known clotting time ranges (normal and abnormal). Used by laboratory personnel or clinicians to verify integrity of newly received test cartridges before patient use. By comparing analyzer output against expected control ranges, user confirms proper cartridge function. Ensures accuracy of coagulation testing performed on the i-STAT system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic quality control material. Formulated to produce specific clotting time ranges (normal/abnormal) for use with i-STAT portable analyzer and cartridges. No electronic, software, or mechanical components; purely chemical/biological control reagents.

Indications for Use

Indicated for use as quality control material for the i-STAT portable Clinical Analyzer and associated aPTT, PT, and ACT test cartridges to verify cartridge integrity. No specific patient population is targeted as this is an in vitro diagnostic quality control product.

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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 5 1998

Michael D. Bick, Ph.D. . Chief Executive Officer Biopool International 6025 Nicolle Street Ventura, California 93003

Re: K981752 i-STAT Coaqulation Control Set Regulatory Class: I Product Code: GGN Dated: May 15, 1998 Received: May 18, 1998

Dear Dr. Bick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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510(k) Number (if known):

4981752

Device Name:

i-STAT Coagulation Control Set

## Indications for Use:

The i-STAT Activated Partial Thromboplastin (aPTT), Prothrombine Time (PT), and Activated Clotting Time (ACT) Controls are intended to be used with the i-STAT portable Clinical Analyzer and i-STAT aPTT, PT, and ACT test cartridges to provide a method for verifying the integrity of newly received cartridges.

The controls produce clotting times within normal ranges and abnormal ranges to indicate that the test cartridges are functioning properly.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

2981752
(Division Sign-Off)
Division of Laboratory...evices
510(k) Number.

Over-The-Counter Use

Prescription Use 1 (Per 21 CFR 801.109)

OR

(Optional Format 1-2-96)

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