(196 days)
Reagent Strips for Urinalysis (qualitative and semi-quantitative) of Urobilinogen, Glucose, Bilirubin, Ketone (acetoacetic acid), Specific Gravity, Blood, pH, Protein, Nitrite, Leukocytes, and Ascorbic Acid in human urine.
CYBOW 11 Reagent Strips are for single use in professional near-patient (pointof-care) and centralized laboratory locations. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas:
- · Kidney function
- · Urinary tract infections
- · Carbohydrate metabolism (e.g. diabetes mellitus)
- · Liver function
- · Acid-base balance
- · Urine concentration
The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the CYBOW 11 Reagent Strips for Urinalysis. This document does not contain the acceptance criteria or the study details you are asking for.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, which means the FDA did not require new clinical studies for its approval. Instead, the clearance is based on the device demonstrating similar performance characteristics to existing, approved devices.
Therefore, I cannot provide the requested information based on the input text. To answer your questions, one would need to access the actual 510(k) submission document (K052525) and any associated performance data that D.F.I. Co. Ltd. provided to the FDA.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the symbol. The caduceus is black, and the text is also black.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 9 2006
D.F.I. Co. Ltd. c/o Asad R. Zaidi President Epinex Diagnostics, Inc. 2815 McGaw Avenue Irvine, CA 92614
Re: K052525
Trade/Device Name: CYBOW 11 Reagent Strips for Urinalysis Regulation Number: 21 CFR& 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, JMA, LJX, JIN, JJB, JIR, JMT, CDM, CEN Dated: February 6, 2006 Received: February 8, 2006
Dear Asad R. Zaidi:
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely vours,
Alberto Gutt
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 052525
Device Name: CYBOW 11 Reagent Strips for Urinalysis
Reagent Strips for Urinalysis (qualitative and semi-quantitative) of Urobilinogen, Glucose, Bilirubin, Ketone (acetoacetic acid), Specific Gravity, Blood, pH, Protein, Nitrite, Leukocytes, and Ascorbic Acid in human urine.
Indications For Use:
CYBOW 11 Reagent Strips are for single use in professional near-patient (pointof-care) and centralized laboratory locations. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas:
- · Kidney function
- · Urinary tract infections
- · Carbohydrate metabolism (e.g. diabetes mellitus)
- · Liver function
- · Acid-base balance
- · Urine concentration
The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
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)
Carol Benam
gnostic
and Safety
K052525
Page 1 of l
§ 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.