(180 days)
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No
The summary describes a standard in vitro diagnostic analyzer for measuring glucose, fructosamine, and AST. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on chemical analysis of biological samples.
No
The device is an in vitro diagnostic procedure used for measuring various substances (glucose, fructosamine, AST) in patient samples to aid in diagnosis and monitoring of conditions, not for direct therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "in vitro diagnostic procedures" and that its measurements are "used in the diagnosis and treatment" of various medical conditions, such as carbohydrate metabolism disorders, liver and heart diseases.
No
The device description is not provided, but the intended use clearly describes a "test system" that measures analytes in biological samples using an "analyzer." This strongly implies the use of hardware (the analyzer) to perform the measurements, making it a hardware-based in vitro diagnostic device, not a software-only device.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the SpotChem EZ Glucose, Fructosamine, and AST test systems are "in vitro diagnostic procedures". This is the primary indicator that the device falls under the category of IVDs.
IVDs are medical devices used to examine specimens taken from the human body, such as blood, serum, or plasma, to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The intended uses described for each test system (measuring Glucose, Fructosamine, and AST in bodily fluids for diagnostic and treatment purposes) align perfectly with the definition of an IVD.
N/A
Intended Use / Indications for Use
The SpotChem EZ Glucose test system is an in vitro diagnostic procedure intended to measure glucose in whole blood, serum, or plasma on the SpotChem EZ analyzer.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of pancreatic isle cell carcinoma.
The SpotChem EZ Fructosamine test system is an in vitro diagnostic procedure intended to measure fructosamine in serum or plasma on the SpotChem EZ analyzer.
Fructosamine measurements are used to assess the level of control of a patient's diabetes and to adjust the proper insulin dose to a patient. Elevated levels of fructosamine indicate uncontrolled diabetes in a patient.
The SpotChem EZ AST test system is an in vitro diagnostic procedure intended to measure AST in serum, plasma, or whole blood on the SpotChem EZ analyzer.
AST measurements are used in the diagnosis and treatment of certain liver and heart diseases.
Product codes (comma separated list FDA assigned to the subject device)
CGA, CIS, LCP
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
Prescription Use
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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§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle faces right and is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" and is arranged around the circle's perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 4 2005
Yuji Yagi ARKRAY, Inc. 57 Nishiaketa-Cho, Higashi-Kujo, Minami-Ku Kyoto, Japan 601-8045
K041427 Re:
R041 127
Trade/Device Name: The SpotChem EZ Glucose Test The SpotChem EZ Fructosamine Test The SpotChem EZ AST Test Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, CIS, LCP Dated: September 27, 2004 Received: October 27, 2004
Dear Yuji Yagi:
This letter corrects our substantially equivalent letter of September 27, 2004 regarding the applicant/ owner which should be listed as Arkray and not Polymedco.
We have reviewed your Section 510(k) premarket notification of intent to market the we have feviewed your bookers a so(=) +--------------------------------------------------------------------------------------------------------------------------------------de vice referenced above and harts enclosure)] to legally marketed predicate devices the mulcations for use stared in the encessor of the enactment date of the Medical marketed in micrisiate commories that have been reclassified in accordance with the Device Amendments of to do recess mannels Act (Act) that do not require approval provisions of the Federal Food, Drog, and otherefore, market the device, subject to the of a prematics approvisions of the Act. The general controls provisions of the Act include general controls provisions of the or areas, 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 If your device is classified (600 a00 10) controls. Existing major regulations affecting your (1 MA), it may be subject to adament of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S Issualice of a substance equirements of the Act
that FDA has made a determination that your device of a complies with of the Act that FDA nas made a decemmanon that your corres by other Federal agencies. You must or any Federal statutes and regulations and limited to registration and listing (21
comply with all the Act's requirements, including, but not manufacturing prestice comply with an the Act 3 requirements, moraaling, it and good manufacturing practice CFR Part 807), labeling (21 CFR Parts 601 and 600), regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will allow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalenced thus, premarked notification. The PDA midning or basisantan 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, of Ir II you desire specific information accur the appear device, please contact the Office of In
or questions on the promotion and advertising of your device, please on the suppor of questions on the promotion and Safety at (240)276-0484. Also, please note the VITO Diagnostic Device Draiaaton and based to premarket notification" (21CFR Part $07.97). You may obtain other general information on your responsibilities under the Act from the You may obtain other general mormation. On Jour Copsumer 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,
Sincerely yours,
Amelia B. Parks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
Cc: Polymedco. Inc Helen Landicho, RAC
2
Indications for Use
1427 510(k) Number (if known): k 040149
Device Name: The SpotChem EZ Glucose Test
Indications For Use:
The SpotChem EZ Glucose test system is an in vitro diagnostic procedure_intended to measure
. I he SpotChemi EZ Grucose test system is an an the SpotChem EZ analyzer.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism
and Glucose measurements are used in the diagliosis and treatment of the carses,
disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of the pancreatic isle cell carcinoma.
Prescription Use __ V (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)
Alberts
__
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k' K041427
Page 1 of 3___________________________________________________________________________________________________________________________________________________________________
3
Indications for Use
510(k) Number (if known): k04
Device Name: The SpotChem EZ Fructosamine Test
Indications For Use:
The SpotChem EZ Fructosamine test system is an in vitro diagnostic procedure intended to I he SpotChem EZ Fractosamine test System is an in The Store on the SpotChem EZ analyzer.
Fructosamine measurements are used to assess the level of control of apatent's diabetes and to Fructosamine the proper insulin dose to a patient. Elevated levels of fructosamine indicate uncontrolled diabetes in a patient.
V 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)
Alberts
__
Division Sign-Off
Office of In Vitro Diac Device Evaluation a
510(k) K041422
Page 2 of 3
4
Indications for Use
1427 510(k) Number (if known): K049444
Device Name:_The SpotChem EZ AST Test
Indications For Use:
The SpotChem EZ AST test system is an in vitro diagnostic procedure intended to measure AST The SpotChem EE AST test byest byest byest on the SpotChem EZ analyzer.
AST mesurements are used in the diagnosis and treatment of certain liver and heart diseases.
V 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)
Allato Sente
Division Sign-Off
Office of In Vitro Diag Device Evaluation
5108: K041427
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