I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2

K120900 · Cliniqa Corporation · GGN · May 31, 2013 · Hematology

Device Facts

• Record ID: K120900
• Device Name: I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
• Applicant: Cliniqa Corporation
• Product Code: GGN · Hematology
• Decision Date: May 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended 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.

Device Story

Cliniqa i-STAT PT and ACT Controls are liquid, stabilized, human-based plasma products used as quality control materials for i-STAT coagulation cartridges. These controls are processed by laboratory personnel to verify the performance of i-STAT handheld and wireless systems. By testing these controls, clinicians ensure the accuracy and reliability of patient coagulation test results (PT and ACT) before performing diagnostic testing. The controls mimic normal and abnormal patient samples, allowing for the detection of potential system errors or cartridge degradation, thereby supporting clinical decision-making in coagulation management.

Clinical Evidence

No clinical data. Bench testing only. Precision and reproducibility studies conducted over 20 days across 3 sites using multiple instruments and operators. All results met pre-specified acceptance criteria (CV < 7.5%). Stability supported by real-time and accelerated studies using the Arrhenius equation to project shelf life.

Technological Characteristics

Lyophilized human plasma; reconstituted with 10mM CaCl2 solution. Analyte levels: PT (INR 1.2-3.0), ACT (80-800 seconds). Storage: 2-8°C. Compatible with Abbott i-STAT handheld/wireless systems. No electronic components; purely chemical control material.

Indications for Use

Indicated for quality control of i-STAT PT and ACT cartridges on i-STAT handheld and wireless systems. 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.

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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

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#### 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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