(118 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, deep learning, or training/test sets for algorithms. The device appears to be a standard in vitro diagnostic test.
No
The device is described as a diagnostic test for measuring lactate levels, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for (1) the diagnosis and treatment of lactic acidosis... (3) diagnosis of hyperlactatemia."
No
The device description is not found, but the intended use and predicate device clearly indicate a physical test cartridge (i-STAT System and CG4+ Cartridge) for in vitro measurement of lactate in blood, which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Lactate Test, as part of the i-STAT System, is intended for the in vitro measurement of lactate in arterial, venous, or capillary whole blood."
The phrase "in vitro measurement" is a key indicator that the device is intended for use outside of the body to examine specimens, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The i-STAT Lactate Test is indicated for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status. (2) monitoring tissue hypoxia and strenuous physical exertion, (3) diagnosis of hyperlactatemia.
The i-STAT Lactate Test, as part of the i-STAT System, is intended for the in vitro measurement of lactate in arterial, venous, or capillary whole blood.
Product codes
KHP
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
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)
Not Found
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
§ 862.1450 Lactic acid test system.
(a)
Identification. A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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510(k) Summary - i-STAT Lactate Test
The summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1900 and CFR 807.92.
. The assigned 510(k) number is: K112430
Summary Prepares on: Friday 19 August 2011
Submitted by: Abbott Point of Care Inc. 400 College Road East Princeton, NJ 08540 Phone: 609-454-9000 Fax: 609-419-9370
Contact: Yuko Hartley Abbott Point of Care Inc. 400 College Road East Princeton, NJ 08540 Phone: 609-454-9271 Fax: 609-419-9370 Email: yuko.hartley@apoc.abbott.com
Establishment Registration Number: 2245578
Identification of Device:
Device Name: i-STAT Lactate Test Proprietary/Trade Name: i-STAT® Lactate Common Name: Lactic Acid, Lactate Device Classification: 1 Registration Number: 21 CFR §862.1450 Panel: Clinical Chemistry Product Code: KHP
Performance Standards:
No applicable standards
Identification of the Predicate Device:
i-STAT Lactate Test part of the CG4+ Cartridge (K982071)
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Indication for Use Statement
The i-STAT Lactate Test is indicated for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status. (2) monitoring tissue hypoxia and strenuous physical exertion, (3) diagnosis of hyperlactatemia.
The i-STAT Lactate Test, as part of the i-STAT System, is intended for the in vitro measurement of lactate in arterial, venous, or capillary whole blood.
Current and proposed labeling for i-STAT Lactate Test
This 510(k) submission supports an additional statement to the "Clinical Significance" section of the labeling.
Current "Clinical Significance" section of the labeling
Elevated levels of lactate are mainly found in conditions of hypoxia such as shock, hypovolemia, and left ventricular failure; in conditions associated with diseases such as diabetes mellitus, neoplasia, and liver disease; and in conditions associated with drugs or toxins such as ethanol, methanol, or salicylates.
Proposed "Clinical Significance" section of the labeling
Elevated levels of lactate are mainly found in conditions of hypoxia such as shock, hypovolemia, and left ventricular failure: in conditions associated with diseases such as diabetes mellitus, neoplasia, and liver disease; and in conditions associated with drugs or toxins such as ethanol, methanol, or salicylates.
Hyperlactatemia is an indicator commonly used to detect tissue hypoperfusion, particularly in the case of sepsis, but also in trauma and surgical settings.
Justification of the Labeling Change
The clinical value of an elevated blood lactate level in patients with sepsis as well as patients with hypoperfusion as the result of trauma or following cardiac surgery has been well established. A comprehensive review of the literature supporting the change to the "Clinical Significance" section has been provided.
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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Abbott Point of Care Inc. c/o Yuko Hartley 400 College Road East Princeton, NJ 08540
DEC 2 0 2011
Re: K112430
Trade name: i-STAT Lactate test Regulation Number: 21 CFR 862.1450 Regulation Name: Lactic Acid Test System Regulatory Class: Class I, meets limitations of exemptions per 21 CFR 862.9(c)(9) Product Code: Dated: November 18, 2011 Received: November 21, 2011
Dear Ms. Hartley:
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 has 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): ___k112430
Device Name: i-STAT Lactate Test
Indications for Use:
The Lactate Acid Test is indicated for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, (3) diagnosis of hyperlactatemia.
The Lactate Test, as part of the i-STAT System, is intended for the in vitro measurement of lactate in arterial, venous, or capillary whole blood.
Prescription Use _ V_
AND/OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801 Subpart D)
(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 Diagnostic Devices (OIVD)
Ruste Chealer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
11243 510(k)
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