(76 days)
Not Found
Not Found
No
The 510(k) summary describes a urine test strip for semi-quantitative determination of various analytes. There is no mention of AI, ML, image processing, or any other technology that would typically indicate the use of AI/ML. The device appears to be a traditional chemical assay test strip.
No.
The device is a diagnostic tool that provides information about various urine components to assess bodily functions, but it does not directly treat or alleviate a disease or condition.
Yes
The device provides "semi-quantitative determination of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, & leukocytes in urine," and these "test results may provide information regarding the status of carbohydrate metabolism, kidney & liver function, acid-base balance, & bacteriurea," which are all indicators of a diagnostic device.
No
The device is a urine test strip, which is a physical, hardware-based diagnostic tool. The summary does not mention any software component.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used for the "semi-quantitative determination of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, & leukocytes in urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a person's health status.
- Sample Type: The device analyzes "urine," which is a biological sample.
- Purpose: The results "may provide information regarding the status of carbohydrate metabolism, kidney & liver function, acid-base balance, & bacteriurea." This directly relates to diagnosing or monitoring health conditions.
These characteristics align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Clinistrip 10 SGL are intend to provide semi-quantitative determination of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, & leukocytes in urine. Tast results may provide information ragarding the status of carbohydrate metabolism, kidney & liver function, acid-base balance, & bacteriurea.
Product codes
JIL, LJX, CDM, CEN, JIN, JIR, JJB, JMT, JRE, JIO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, depicted with stylized lines.
10903 New Hampshire Avenue Silver Spring, MD 20993
TECO Diagnostics c/o Andrew Reams 4925 E. Hunter Avenue Anaheim, CA 92807
Re:
2 6 2013
K970250 Trade Name: CLINISTRIP Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Codes: JIL, LJX, CDM, CEN, JIN, JIR, JJB, JMT, JRE, JIO Dated: January 17, 1997 Received: January 22, 1997
Dear Mr. Reams:
This letter corrects our substantially equivalent letter of April 8, 1997.
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 (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, controls provisions of abeling, 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
1
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Devices and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH'S Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-576-. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
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) 796-5680 or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Sincerely yours,
Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
@002
510(k) Number (if known):_
Page __ of __
Device Name: Clinistrip 10 SGL
Indications For Use:
Clinistrip 10 SGL are intend to provide
semi-quantitative determination of glucose,
bilirubin, ketone, specific gravity, blood,
pH, protein, urobilinogen, nitrite, &
leukocytes in urine. Tast results may
provide information ragarding the status
of carbohydrate metabolism, kidney &
liver function, acid-base balance, &
bacteriurea.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K970250
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | \checkmark |
| OR | Over-The-Counter Use (Optional Format 1-2-96) |