I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02

K071319 · Bio-Rad, Diagnostics Grp. · GGN · Jun 26, 2007 · Hematology

Device Facts

• Record ID: K071319
• Device Name: I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
• Applicant: Bio-Rad, Diagnostics Grp.
• Product Code: GGN · Hematology
• Decision Date: Jun 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

i-STAT Activated Clotting Time (ACT) Control is used to verify the integrity of newly received i-STAT Activated Clotting Time cartridges.

Device Story

The i-STAT Activated Clotting Time (ACT) Control Set is a lyophilized human plasma-based product used for quality control. It is designed to verify the integrity of newly received i-STAT ACT cartridges before clinical use. The control is reconstituted and applied to the cartridge; the i-STAT system then processes the sample to ensure the cartridge is functioning correctly. This process allows healthcare providers to confirm the reliability of coagulation testing results, ensuring accurate clinical decision-making regarding patient anticoagulation status. The device is intended for use by clinical laboratory personnel or healthcare professionals in point-of-care or clinical settings.

Clinical Evidence

No clinical data. Bench testing only. Stability studies conducted on three experimental lots over 18 months at 2-8°C demonstrated analyte results within ±10% deviation of reference values stored at -70°C. Precision data (mean, SD, CV) provided for both levels across three lots, confirming recovery within target ranges (150-250s for Level 1; 450-650s for Level 2).

Technological Characteristics

Lyophilized human plasma control. Reconstituted for use. Storage at 2 to 8°C. No electronic or software components; purely a chemical/biological control reagent.

Indications for Use

Indicated for use as a quality control material to verify the integrity of i-STAT Activated Clotting Time cartridges. Intended for professional use in clinical settings.

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

• i-STAT Coagulation Control Set (K981752)

Submission Summary (Full Text)

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07/3/9

## Bio-Rad Laboratories i-STAT Activated Clotting Time (ACT) Control Set Summary of Safety and Effectiveness

#### 1.0 Submitter

..............................................................................................................................................................................

JUN 2 6 2007

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 [phone] Telephone: [phone] Fax:

### Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

### Date of Summary Preparation

May 7, 2007

#### 2.0 Device Identification

| Product Name: | i-STAT Activated Clotting Time (ACT) Control Set |
|---------------|-----------------------------------------------------------------|
| Common Name: | Plasma, coagulation control<br>Hematology and Pathology Devices |

Classifications: Product Code: Regulation Number: Class II GGN 21 CFR 864.5425

#### Device to Which Substantial Equivalence is Claimed 3.0

i-STAT COAGULATION CONTROL SET BIOPOOL INTL., INC. 6025 Nicolle St. Ventura, CA 93003

510 (k) Number: K981752

#### 4.0 Description of Device

This is a lyophilized product prepared from human plasma, with added purified I mo to a ly ophilizes. The control is provided in lyophilized form for increased stability.

#### 5.0 Intended Use

i-STAT Activated Clotting Time (ACT) Control is used to verify the integrity of newly received i-STAT Activated Clotting Time cartridges.

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#### 6.0 Comparison of the new device with the Predicate Device

i-STAT Activated Clotting Time (ACT) Control Set claims substantial equivalence to the i-STAT Coagulation Control Set currently in commercial distribution (K981752).

| | Bio-Rad Laboratories<br>Activated Clotting Time (ACT) Control Set<br>(New Device) | BIOPOOL INTL., INC<br>i-STAT Coagulation Control Set<br>(Predicate Device K981752) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Similarities | |
| Intended Use | i-STAT Activated Clotting Time (ACT) Control<br>Set is used to verify the integrity of newly<br>received I-STAT Activated Clotting Time<br>cartridges. | i-STAT Coagulation Control Set is intended<br>for use to verify the integrity of newly<br>newly received i-STAT ACT cartridges. |
| Matrix | Human plasma | Human plasma |
| Form | Lyophilized | Lyophilized |
| Storage (Unopened) | Refrigerated (2 to 8°C) | Refrigerated (2 to 10°C) |
| Open Vial stability | Use immediately | Use immediately |

| Table 1. Similarities and Differences between new and predicate device. | | |
|-------------------------------------------------------------------------|--|--------------------------------------------------------------------|
| | | Comments of the Callery of Children Courts College of Children and |

#### 7.0 Statement of Supporting Data

Stability studies have been performed to determine shelf life for this control. Product claims are as follows:

- Shelf Life: 18 months at 2 to 8°C .
All supporting data is retained on file at Bio-Rad Laboratories.

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# Indications for Use

510(k) Number (if known):

Device Name:

I-STAT ACT Control Set

Indications For Use:

i-STAT® Activated Clotting Time (ACT) Control is used to verify the integrity of newly received i-STAT® Activated Clotting Time cartridges.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 6 2007

Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017

Re: k071319

Trade/Device Name: i-STAT Activated Clotting Time (ACT) Control Set Regulation Number: 21 CFR 864.5425 Regulation Name: Plasma, coagulation control; Hematology and Pathology Devices Regulatory Class: Class II Product Code: GGN Dated: June 4, 2007 Received: June 6, 2007

Dear Ms. Zeballos:

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 bas 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). This letter

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Page 2 – Maria Zeballos

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,

Robert H. Becker, f

Robert L. Becker, Jr., MD, PhD 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

510(k) Number (if known):

Device Name:

I-STAT ACT Control Set

Indications For Use:

i-STAT® Activated Clotting Time (ACT) Control is used to verify the integrity of newly received i-STAT® Activated Clotting Time cartridges.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Sachine Bautista
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

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