(219 days)
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Not Found
No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description focuses on microprocessor control and disposable test books, not AI/ML algorithms.
No
This device is an analyzer that determines specific analytes to monitor electrolyte balance and aid in diagnosis and treatment, but it does not directly apply therapy.
Yes
The device is used for the "quantitative determination of specific analytes" (potassium) and its measurements are used "in the diagnosis and treatment of conditions characterized by low or high blood potassium levels." This indicates its role in providing information for diagnosis.
No
The device description explicitly states it is a "microprocessor-controlled instrument" and "deploys single-use, single analyte disposable test books," indicating it includes hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of specific analytes in whole blood and plasma." This involves testing biological samples in vitro (outside the body).
- Analyte Measurement: It measures potassium levels in blood and plasma, which are common analytes tested in clinical laboratories.
- Diagnostic Purpose: The potassium measurements are used "to monitor electrolyte balance in the diagnosis and treatment of conditions characterized by low or high blood potassium levels." This clearly indicates a diagnostic purpose.
- Sample Type: It uses whole blood and plasma, which are biological specimens.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CAC Bio-Chem Analyzer™ fits this definition.
N/A
Intended Use / Indications for Use
The CAC Bio-Chem AnalyzerTM is a microprocessor-controlled instrument for the quantitative determination of specific analytes in whole blood and plasma. The instrument deploys single-use, single analyte disposable packs for the following test analyte: potassium.
Potassium measurements obtained by this device are used to assess electrolyte balance in the diagnosis and treatment monitor various conditions characterized by low or high blood potassium levels.
The CAC Bio-Chem AnalyzerTM is a point-of-care device intended for hospital-use settings.
Product codes
CEM
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
hospital-use settings.
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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§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of three parallel lines that curve and resemble a human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 8 2004
Mr. Charles McBrairty Execututive Vice President R&D Clinical Analysis Corporation 2100 Quaker Pointe Drive Quakertown, PA 18951-2182
K040750 Re:
Trade/Device Name: CAC Bio-Chem Analyzer™ Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Code: CEM Dated: October 7, 2004 Received: October 8, 2004
Dear Mr. McBrairty:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you to ough finding of substantial equivalence of your device to a legally promatication of the 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, If you dostre specific mission and advertising of your device, please contact the Office of or questions on the promise Evaluation and Safety at (301) 594-3084. 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 I va may ookun battle getecturers, 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. 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
510(k) Number (if known): K040750
Device Name: CAC Bio-Chem AnalyzerTM
Indications For Use:
malousono . C. C. C. C. . AnalyzerTM is a microprocessor-controlled rne the blow onem instrument for the quantitative ercermination of specific analytes in whole blood and plasma. deceimination or bposs single-use, single analyte disposable ine instrument deploys books of the following test analyte: potassium
Potassium measurements obtained by this device are used to rocusbram moderalyte balance in the diagnosis and treatment monitir ses conditions characterized by low or high blood potassium levels.
The CAC Bio-Chem Analyzer™ is a point-of-care device intended for hospital-use settings.
Prescription Use (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)
Division Sign-Off
Office of In Vitro Diagnostic
510(k) K040750
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