(52 days)
Urinalysis Reagent Strips provide tests for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leucocytes in urine.
Not Found
The document provided is a 510(k) clearance letter from the FDA for "Urinalysis Reagent Strips (10 Parameters)". This type of document assesses substantial equivalence to a predicate device, rather than detailed performance reports or clinical study results as would be found in a Premarket Approval (PMA) application. Therefore, the information requested about acceptance criteria, study details, and ground truth establishment is not available in this document.
The primary function of a 510(k) notification is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. This typically involves submitting information on design, materials, chemical composition, energy source, manufacturing process, and intended use, along with performance data demonstrating equivalence to the predicate device. However, the FDA letter itself does not contain the detailed performance data or study methodology that would typically be included in a scientific study report.
Here's a breakdown of why each requested piece of information cannot be provided based on the given text:
- 1. A table of acceptance criteria and the reported device performance: This document is the FDA's clearance letter, not the study report itself. It states that the device is "substantially equivalent" but does not provide specific performance metrics or acceptance criteria tables.
- 2. Sample size used for the test set and the data provenance: Not present in this regulatory clearance letter. The original 510(k) submission would have contained this information.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- 4. Adjudication method for the test set: Not present.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for a device like urinalysis reagent strips, which are not typically "read" by multiple human readers in the same way as, for example, medical images for diagnosis. Even if a comparative study was done to demonstrate equivalence to the predicate device, details are not in this letter.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. These are reagent strips that produce a visual color change interpreted by a human, not an algorithm.
- 7. The type of ground truth used: Not present. For a diagnostic device like reagent strips, ground truth would likely involve more definitive laboratory methods (e.g., standard chemical analysis) to confirm the presence and concentration of the analytes.
- 8. The sample size for the training set: Not present.
- 9. How the ground truth for the training set was established: Not present.
To obtain the detailed study information, one would typically need to refer to the original 510(k) submission documentation filed with the FDA, which is a much more extensive technical package than the clearance letter provided.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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JAN - 3 2000
Mr. Dennis S. Hong, B.Sc., B.M.L.Sc. Vice President International Newtech Development Inc. 1629 Fosters Way Delta, BC V3M 6S7 CANADA
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K993850
Trade Name: Urinalysis Reagent Strips (10 Parameters) Regulatory Class: II Product Code: JIL, JIO Regulatory Class: I Product Code: JMT, JIN, CIN, JMA, JIR, JJB, CDM, JMZ Dated: November 4, 1999 Received: November 12, 1999
Dear Mr. Hong:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _
Urinalysis Reagent Strips (10 Parameters) Device Name:
29938.5
Indications For Use:
Urinalysis Reagent Strips provide tests for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leucocytes in urine.
Dennis S.L. Hong, B.Sc., B.M.L.Sc. Vice-President International Newtech Development Inc.
Dan Coogler
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993850
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 862.1510 Nitrite (nonquantitative) test system.
(a)
Identification. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.(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.