(155 days)
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No
The summary describes a qualitative urine test for blood, which is a standard chemical assay and does not mention any AI/ML components or image processing.
No
The device is described as a diagnostic tool used for qualitative determination of blood in human urine, aiding in the diagnosis and treatment of conditions like hematuria and glomerulonephritis. It does not actively treat or provide therapy.
Yes
The text explicitly states "Urinary blood measurements are used in the diagnosis and treatment of hematuria and glomerulonephritis," indicating its role in determining a medical condition.
No
The 510(k) summary describes a "test" for determining blood in human urine, which strongly implies a physical test strip or other hardware component is involved in the measurement process, not just software analysis.
Based on the provided information, the TECO Diagnostics URS-1B (Blood Test) is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of blood in human urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body).
- Purpose: The test is used in the "diagnosis and treatment of hematuria and glomerulonephritis," which are medical conditions. IVDs are used to provide information for diagnosis, monitoring, or treatment.
- Sample Type: The test analyzes "human urine," which is a biological specimen.
The definition of an IVD generally includes 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. The TECO Diagnostics URS-1B fits this description.
N/A
Intended Use / Indications for Use
The TECO Diagnostics URS-1B (Blood Test) is intended for "Professional Use." The test is used, by professional people, for a qualitative determination of blood in human urine. Urinary blood measurements are used in the diagnosis and treatment of hematuria and glomerulonephritis.
Product codes
JIO
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
human urine
Indicated Patient Age Range
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Intended User / Care Setting
Professional 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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 0 6 2003
Ms. Lisa To Official FDA Correspondent Teco Diagnostics 1268 N. Lakeview Avenue Anaheim, CA 92807
Re: K023297
Trade/Device Name: URS-1B (Blood Test) Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: JIO Dated: December 16, 2002 Received: December 23, 2002
Dear Ms. To:
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) 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device 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 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 3
INDICATIONS FOR USE STATEMENT
510 (K) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The TECO Diagnostics URS-1B (Blood Test) is intended for "Professional Use." The test is used, by professional people, for a qualitative determination of blood in human urine. Urinary blood measurements are used in the diagnosis and treatment of hematuria and glomerulonephritis.
Stau Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. KD23297
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use