(45 days)
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No
The provided text describes a standard in vitro diagnostic test for carbon dioxide and contains no mention of AI, ML, or related concepts.
No.
The device is used for in vitro diagnostic (IVD) measurement of carbon dioxide in human serum, which is for diagnosis and monitoring of acid-base balance, not directly for therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that carbon dioxide measurements are used in the "diagnosis and treatment" of disorders.
No
The intended use describes an in vitro diagnostic test for carbon dioxide in human serum, which inherently involves laboratory equipment and reagents, not just software. The lack of a device description further prevents confirmation of a software-only nature.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states it is "Intended for the In Vitro, quantitative determination of carbon dioxide in human serum". The term "In Vitro" is a key indicator of an IVD.
- Sample Type: It specifies the analysis of "human serum", which is a biological sample taken from the body.
- Purpose: The purpose is for "quantitative determination of carbon dioxide", which is a measurement of a substance in a biological sample.
- Clinical Relevance: The intended use also mentions that these measurements are "used in the diagnosis and treatment of numerous potentially serious disorders", highlighting its role in clinical decision-making.
All these elements align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
Intended for the In Vitro, quantitative determination of carbon dioxide in human serum on automated chemistry analyzers.
Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Product codes
KHS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be a human figure in profile, represented by three curved lines.
SEP - 6 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. David Johnston JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166
Re: K012332
Trade/Device Name: JAS Carbon Dioxide Liquid Reagent Regulation Number: 21 CFR 862.1160 Regulatory Class: II Product Code: KHS Dated: July 2, 2001 Received: July 23, 2001
Dear Mr. Johnston:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have levelowed your with device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Intersate commore prive to hat have been reclassified in accordance with the provisions of the Amendinonis, of to devices and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include the general officers provision, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarker ripproval), in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such periodic on. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, 1 27 Thia) publication submission submission submission submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the any oongained you t Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _ Carbon Dioxide REAGENT Indications for Use:
Intended for the In Vitro, quantitative determination of carbon dioxide in human serum on automated chemistry analyzers.
Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Alexander by Jean Cooper
Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012332
Prescription Use_V (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)