(47 days)
Not Found
No
The summary describes a lyophilized control product for verifying the integrity of cartridges, with no mention of AI or ML technology in its function or description.
No
The device is described as a control product used to verify the integrity of cartridges, not to treat a medical condition or disease.
No
The device is described as a "Control" used to "verify the integrity" of cartridges for another device. It does not diagnose a condition in a patient; rather, it assesses the functionality of a diagnostic tool.
No
The device description explicitly states it is a "lyophilized product prepared from human plasma," indicating it is a physical substance, not software.
Based on the provided information, the i-STAT® Activated Clotting Time (ACT) Control is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it is "used to verify the integrity of newly received i-STAT® Activated Clotting Time cartridges." This indicates it is used in vitro (outside the body) to assess the performance of another diagnostic device (the i-STAT ACT cartridges).
- Device Description: It is a "lyophilized product prepared from human plasma," which is a biological material used in laboratory testing.
- Predicate Device: The mention of a predicate device (K981752; i-STAT COAGULATION CONTROL SET) strongly suggests that this device is regulated as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
While it doesn't directly diagnose a disease or condition in a patient, it is a crucial component in ensuring the accuracy and reliability of an IVD test (the i-STAT ACT test). Therefore, it falls under the category of an IVD control or calibrator.
N/A
Intended Use / 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.
Product codes
GGN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 control |
| 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.
1
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
Activated Clotting Time (ACT) Control Set
(New Device) | BIOPOOL INTL., INC
i-STAT Coagulation Control Set
(Predicate Device K981752) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Similarities | |
| Intended Use | i-STAT Activated Clotting Time (ACT) Control
Set is used to verify the integrity of newly
received I-STAT Activated Clotting Time
cartridges. | i-STAT Coagulation Control Set is intended
for use to verify the integrity of newly
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.
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