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.

AI/ML Overview

The provided document describes the Bio-Rad Laboratories i-STAT Activated Clotting Time (ACT) Control Set, a device used to verify the integrity of newly received i-STAT ACT cartridges. This is a 510(k) premarket notification, which means the device claims substantial equivalence to a legally marketed predicate device (i-STAT Coagulation Control Set, K981752), rather than undergoing a de novo clinical trial to prove efficacy.

Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a new device would. Instead, the "study" referred to here is a comparison to a predicate device and stability studies.

Here's a breakdown of the requested information based on the provided text, with many points indicating that the information is "Not Applicable" or "Not Provided" due to the nature of a 510(k) submission for a control set:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document implies that the primary acceptance criterion is that the new device performs similarly enough to the predicate device to be considered substantially equivalent for its intended use. For an IVD control, this typically means:

Intended Use: Identical.
Matrix: Identical.
Form: Identical.
Storage (Unopened): Similar (2 to 8°C vs. 2 to 10°C).
Open Vial Stability: Identical ("Use immediately").
Shelf Life: Established through stability testing.

Reported Device Performance:

Characteristic	Accepted (Bio-Rad Laboratories ACT Control Set)	Predicate (BIOPOOL INTL., INC i-STAT Coagulation Control Set)
Intended Use	Verify integrity of newly received i-STAT ACT cartridges.	Verify integrity of 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
Shelf Life	18 months at 2 to 8°C (supported by internal stability studies)	Not explicitly stated in comparison, but inherent to predicate's regulatory clearance.

2. Sample Size for Test Set and Data Provenance

Sample Size: Not provided. The submission refers to "Stability studies" and "All supporting data is retained on file at Bio-Rad Laboratories." This implies internal testing rather than a large clinical test set.
Data Provenance: Not provided, but given it's a Bio-Rad submission, the data is likely from internal testing by the manufacturer. The document does not specify country of origin or if it's retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. As a control set, its performance is determined by its chemical and biological properties, and its stability over time. It's not a diagnostic device that requires expert interpretation of results to establish a "ground truth" in the diagnostic sense. The ground truth for this device would be its validated chemical properties and stability, confirmed by laboratory testing.

4. Adjudication Method

Not Applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This device is a control set, not an AI or diagnostic tool that involves human readers or interpretation of complex cases. Therefore, an MRMC study is not relevant.

6. Standalone Performance Study (Algorithm Only)

Not Applicable. This is a physical control product, not an algorithm. Its "performance" is its ability to remain stable and provide expected results for verifying other devices.

7. Type of Ground Truth Used

The "ground truth" for this device would be established through laboratory testing and analytical methods to confirm the composition and stability of the human plasma and other components. Specifically, "Stability studies have been performed to determine shelf life for this control," indicating that these studies form the basis of the performance claims.

8. Sample Size for the Training Set

Not Applicable. This is a physical control product, not a machine learning algorithm, so there is no "training set."

9. How Ground Truth for Training Set was Established

Not Applicable. See point 8.

Summary

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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 (949) 598-1200 Telephone: (949) 598-1557 Fax:

Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367

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 controlHematology 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 LaboratoriesActivated Clotting Time (ACT) Control Set(New Device)	BIOPOOL INTL., INCi-STAT Coagulation Control Set(Predicate Device K981752)
Characteristics	Similarities
Intended Use	i-STAT Activated Clotting Time (ACT) ControlSet is used to verify the integrity of newlyreceived I-STAT Activated Clotting Timecartridges.	i-STAT Coagulation Control Set is intendedfor use to verify the integrity of newlynewly 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.

Page 2 of 2

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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)

رار vision Sign-Off

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Office of In Vitro Diagnostic Device Evaluation and Safety

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

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 (240) 276-0450. 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 (800) 638-2041 or (240) 276-3150, 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

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

K07/3/9

Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
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.(b)
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.