(249 days)
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No
The device description explicitly states that the strips are read by "visual comparing color chart," indicating a manual, non-AI/ML based interpretation method. There are no mentions of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
No
The device is a diagnostic tool used to screen for microalbuminuria, which aids in detecting kidney damage. It is not used for treatment or therapy.
Yes
This device is designed to detect microalbuminuria and measure creatinine levels in urine, which are used in the diagnosis and monitoring of renal diseases and kidney damage. This directly aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "strip" that is read by "visual comparing color chart," indicating a physical test strip and a non-software-based reading method.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to test urine samples ("random urine") for specific analytes (Microalbumin and Creatinine) to aid in the diagnosis and monitoring of renal diseases. This is a classic characteristic of an IVD.
- Device Description: The description reinforces that the device is a "strip" used to test urine and provide "semi-quantitative results" for these analytes.
- Purpose: The purpose is to screen urine specimens for microalbuminuria as an "aid in the detection of patients at risk for developing kidney damage." This diagnostic purpose is central to the definition of an IVD.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that definition by analyzing a biological sample (urine) to provide information relevant to the diagnosis and monitoring of kidney health.
N/A
Intended Use / Indications for Use
Teco Diagnostics Microalbumin 2-1 combo Strip is designed to give semi-quantitative results for Microalbumin and Creatinine in random urine and also determine the albumin to creatinine ratio in random urine.
Microalbuminuria, an abnormal elevation of the urinary albumin excretion rate, is many times one of the first signs of renal diseases and renal damage that can lead to renal failure.
Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
The Teco Microalbumin 2-1 Combo Strips are read by visual comparing color chart.
Teco Microalbumin 2-1 Combo Strips are recommended for use in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.
Product codes
JFY, JIR
Device Description
Teco Diagnostics Microalbumin 2-1 combo Strip is designed to give semi-quantitative results for Microalbumin and Creatinine in random urine and also determine the albumin to creatinine ratio in random urine.
The Teco Microalbumin 2-1 Combo Strips are read by visual comparing color chart.
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
random urine
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(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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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services, USA. The seal is circular and contains an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are written around the edge of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
TECO Diagnostics 1268 North Lakeview Avenue Anaheim, CA 92807 Attn: Jian Vaeches
JAN 2 6 2007
Re: K061419 Trade/Device Name: Teco Microalbumin 2-1 Combo Strips Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system. Regulatory Class: Class II Product Code: JFY, JIR Dated: January 11, 2007 Received: January 11, 2007
Dear Mr. Vaeches:
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 mo letter watification. The FDA finding of substantial equivalence of your device to a legally promative in licate device 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, r you desire specific mostion and advertising of your device, please contact the Office of In or questions on the promie Evaluation and Safety at (240) 276-0490. 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 of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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
2
Indications for Use
510(k) Number (if known): Unknown at this time
Device Name: Teco Microalbumin 2-1 Combo Strips
Indications for Use: Teco Diagnostics Microalbumin 2-1 combo Strip is designed to give semi-quantitative results for Microalbumin and Creatinine in random urine and also determine the albumin to creatinine ratio in random urine.
Microalbuminuria, an abnormal elevation of the urinary albumin excretion rate, is many times one of the first signs of renal diseases and renal damage that can lead to renal failure.
Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
The Teco Microalbumin 2-1 Combo Strips are read by visual comparing color chart.
Teco Microalbumin 2-1 Combo Strips are recommended for use in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Carol C Benson
Office
Evaluation
nostic Device
K 061419