(431 days)
Not Found
Not Found
No
The document describes quality control materials for existing i-STAT systems and cartridges, with no mention of AI or ML in the intended use or other sections.
No
The device is described as controls used for quality control of diagnostic cartridges, not for treating a disease or condition.
No
The device is described as being used for quality control of cartridges on i-STAT systems, not for diagnosing medical conditions itself.
No
The summary describes quality control materials (liquids) for testing cartridges used with i-STAT systems, not a software application itself.
Based on the provided information, the device described is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are used for "quality control of i-STAT PT cartridges on i-STAT handheld and wireless systems" and "quality control of i-STAT ACT cartridges on i-STAT handheld and wireless systems."
- Nature of the Device: These are control materials used to verify the performance of other in vitro diagnostic devices (the i-STAT cartridges and systems). Quality control materials for IVDs are themselves considered IVDs.
While the document lacks a "Device Description," the intended use clearly places these controls within the realm of in vitro diagnostics. They are used in vitro (outside the body) to assess the accuracy and reliability of diagnostic tests.
N/A
Intended Use / Indications for Use
The i-STAT PT Control Level 1 (normal) and PT Control Level 2 (abnormal) are used for quality control of i-STAT PT cartridges on i-STAT handheld and wireless systems.
The i-STAT ACT Control Level 1 (normal) and ACT Control Level 2 (abnormal) are used for quality control of i-STAT ACT cartridges on i-STAT handheld and wireless systems.
Product codes
GGN
Device Description
Not Found
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
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2013
CLINIQA CORPORATION c/o MS. DA WN GAST DIRECTOR, QUALITY AND REGULATORY AFFAIRS 288 DISTRIBUTION STREET SAN MARCOS CA 92078
Re: K120900
Trade/Device Name: Cliniqa i-STAT PT Control Level 1 Cliniqa i-STAT PT Control Level 2 Cliniqa i-STAT ACT Control Level 1 Cliniqa i-STAT ACT Control Level 2
Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: GGN Dated: April 29, 2013 Received: April 30, 2013
Dear Ms. Gast:
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 10, 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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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 that FDA has made a determination that vour 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
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Page 2-Ms. Dawn Gast
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Maria M. Chan -S
Maria M. Chan, Ph.D. Director -Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use Form
510(k) Number (if known):
Device Name:
Cliniga i-STAT PT Control Level 1
Cliniqa i-STAT PT Control Level 2
Indications For Use:
The i-STAT PT Control Level 1 (normal) and PT Control Level 2 (abnormal) are used for quality control of i-STAT PT cartridges on i-STAT handheld and wireless systems.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF-NEEDED)-
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Seuk R. S
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K120900
Page 1 of 2
3
Indications for Use Form
510(k) Number (if known): K120900
Device Name:
Cliniqa i-STAT ACT Control Level 1
Cliniqa i-STAT ACT Control Level 2
Indications For Use:
The i-STAT ACT Control Level 1 (normal) and ACT Control Level 2 (abnormal) are used for quality control of i-STAT ACT cartridges on i-STAT handheld and wireless systems.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
..
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Seach R.K.
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K120900
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