(162 days)
Not Found
Bayer Corporation MULTISTIX 10 SG Reagent Strips (K-file not identified), Behring Diagnostics RAPIGNOST TOTAL SCREEN L Urine Test Strips (K861255), Boehringer Mannheim CHEMSTRIP 10 with SG Urine Test Strips (K896454), International Newtech Development Urinalysis Reagent Strips (10 Parameters) (K993850)
No
The device description and performance studies focus on chemical reagent strips read visually or instrumentally, with no mention of AI or ML algorithms for interpretation or analysis.
No
The device is described as diagnostic, providing information for screening and ruling out disease states, rather than treating or preventing them.
Yes
The device provides qualitative and semi-quantitative tests for various substances in urine, and the results "may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria." Additionally, it states that "Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed." These are all functions characteristic of a diagnostic device.
No
The device is a physical reagent strip used for chemical analysis of urine, which is a hardware component. While it can be read instrumentally, the core device is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the strips "provide qualitative and semi-quantitative tests for... in urine" and that "Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria." This indicates the device is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes.
- Device Description: The description details a "firm plastic, dry reagent strip" with "reagent areas" that are "dipped into the urine sample" and read to obtain results. This aligns with the definition of an in vitro diagnostic device, which is used outside of the body to examine specimens.
- Performance Studies: The document describes performance studies conducted in "clinical laboratory settings" where the strips were used to test urine samples and the results were compared to other laboratory methods and predicate devices. This further confirms its use in a diagnostic context.
- Predicate Devices: The listed predicate devices are all known IVD urinalysis strips.
Therefore, based on the provided information, the URISTIK H Series Reagent Strips meet the criteria for an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
URISTIK H Series Reagent Strips provide qualitative and semi-quantitative tests for ascorbic acid, pH, specific gravity, ketones (acetoacetic acid), blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
Dirui H Series Reagent Strips are for single use in professional near-patient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening in the following areas:
- Kidney function
- Urinary tract infections
- Carbohydrate metabolism (e.g. diabetes mellitus)
- Liver function
- Acid-base balance
- Urine concentration
Test results can be used along with other diagnostic information to rule out certain disease states or to determine if a microscopic analysis is needed.
Prescription Use (Part 21 CFR 801 Subpart D)
Product codes (comma separated list FDA assigned to the subject device)
JIO, JIL, KQO, JRE, JMA, CEN, LJX, JMT, JIR, JIN, JJQ, CDM
Device Description
URISTIK H Series Reagent Strips For Urinalysis provide qualitative and semiquantitative tests for ascorbic acid, pH, specific gravity, ketones, blood, protein, nitrite, leukocytes, glucose, bilirubin and urobilinogen in urine. URISTIK H Series Reagent Strips For Urinalysis are firm plastic, dry reagent strips. The reagent areas are dipped into the urine sample and read visually according to a color chart or are read instrumentally with a Dirui H-50, H-100, or H-500 Urine Analyzer. The results are available within one minute. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.
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
professional use in point-of-care (POC) testing such as in hospitals, clinics, and clinical laboratories.
professional users in centralized and point-of-care (POC) hospital, clinic, and doctor's office settings
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)
The performance of URISTIK H Series Reagent Strips For Urinalysis was studied in clinical laboratory settings by professional users. The strips were read visually and instrumentally using Dirui H Series Urine Analyzers. The results were compared to results obtained from Bayer MULTISTIX 10 SG Reagent Strips and from laboratory test methods. The studies demonstrated that professional users in centralized and point-of-care (POC) hospital, clinic, and doctor's office settings can obtain valid urinalysis test results.
Dirui studies showed that the URISTIK H Series Reagent Strips For Urinalysis provide test results consistent with laboratory methods and performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips in POC settings.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Bayer Corporation MULTISTIX 10 SG Reagent Strips (K-file not identified), Behring Diagnostics RAPIGNOST TOTAL SCREEN L Urine Test Strips (K861255), Boehringer Mannheim CHEMSTRIP 10 with SG Urine Test Strips (K896454), International Newtech Development Urinalysis Reagent Strips (10 Parameters) (K993850)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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AUG 2 6 2004
Image /page/0/Picture/2 description: The image contains the logo and contact information for "Changchun Dirui Industrial Co., Ltd." The address is "95, Yunhe St., New& High Tech. Development Zone, Changchun, 130012, China." The telephone number is (86 431) 5100409, and the fax number is (86 431) 5173354. The email address is dr@public.cc.jl.cn, and the website is http://www.dirui.com.cn.
510(k) Summary
February 13, 2004 Prepared:
Dirui Industrial Co. Ltd. Submitter:
Address: 95 Yunhe Street New & High Technology Development Zone Changchun, 130012, China
Contact Person (U.S. Agent):
Joseph F. Ludford U.S. Conformity Consultants, Inc. 7560 Lindbergh Drive Gaithersburg, MD 20879 Tel: 301-417-0220 Fax: 301-417-9069
Trade/Proprietary Name:
URISTIK H Series Reagent Strips For Urinalysis
Common/Usual Name:
Urinalysis Test Strips
Classification Names:
Occult blood test (21 CFR 864.6550) - Class II Urinary glucose (nonquantitative) test system (21 CFR 862.1340) - Class II Urinary urobilinogen (nonquantitative) test system (21 CFR 862.1785) - Class I Urinary bilirubin and its conjugates (nonquantitative) test system (21 CFR 862.1115) - Class I Ketones (nonquantitative) test system (21 CFR 862.1435) - Class I Urinary protein or albumin (nonquantitative) test system (21 CFR 862.1645) - Class I Nitrite (nonquantitative) test system (21 CFR 862.1510) - Class I Leukocyte peroxidase test (21 CFR 864.7675) - Class I Urinary pH (nonquantitative) test system (21 CFR 862.1550) - Class I Ascorbic acid test system (21 CFR 862.1095) - Class I Specific gravity test (not classified in 21 CFR 862 or 864) - proposed Class I
1
Image /page/1/Picture/0 description: The image shows the logo and contact information for DIRUI Industrial Co., Ltd. The address is 95 Yunhe St., New & High Tech. Development Zone, Changchun, 130012, China. The telephone number is (86431) 5100409, and the fax number is (86431) 5173354. The email address is dr@public.cc.jl.cn, and the website is http://www.dirui.com.cn.
Note: Occult blood test and urinary glucose test are the subject of this submission.
Legally marketed devices to which we are claiming equivalence:
Bayer Corporation MULTISTIX 10 SG Reagent Strips (K-file not identified) Behring Diagnostics RAPIGNOST TOTAL SCREEN L Urine Test Strips (K861255) Boehringer Mannheim CHEMSTRIP 10 with SG Urine Test Strips (K896454) International Newtech Development Urinalysis Reagent Strips (10 Parameters) (K993850)
Device Description:
URISTIK H Series Reagent Strips For Urinalysis provide qualitative and semiquantitative tests for ascorbic acid, pH, specific gravity, ketones, blood, protein, nitrite, leukocytes, glucose, bilirubin and urobilinogen in urine. URISTIK H Series Reagent Strips For Urinalysis are firm plastic, dry reagent strips. The reagent areas are dipped into the urine sample and read visually according to a color chart or are read instrumentally with a Dirui H-50, H-100, or H-500 Urine Analyzer. The results are available within one minute. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.
Intended Use:
URISTIK H Series Reagent Strips For Urinalysis are for professional use in pointof-care (POC) testing such as in hospitals, clinics, and clinical laboratories. The reagent strips are intended for use to assist diagnosis of the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria.
Technological Characteristics:
URISTIK H Series Reagent Strips For Urinalysis include reagent areas for assessing the presence of occult blood and urine glucose. A high concentration of ascorbic acid will effect the test for glucose. Ascorbic acid is reported from 0.6 to 5.0 mmol/L. A glucose reagent is used that measures glucose levels from 5.5 to 55 mmol/L. A blood reagent is used that measures occult blood levels from 10 to 200cells/ µ L.
The test for glucose is based on the glucose-specific glucose oxidase/peroxidase method. Oxidation of glucose forms hydrogen peroxide, which in turn oxidizes a chromogen in the peroxidase reaction to generate green or blue color. The test for blood is based on the peroxidase activity of hemoglobin and myoglobin creating a green color with oxidation of a chromogen. Intact erythrocytes which hemolyze on the test paper will produce a green dot.
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Image /page/2/Picture/0 description: The image shows the logo and contact information for Changchun Dirui Industrial Co., Ltd. The logo consists of the company name in Chinese characters and the English name "DIRUI" in a stylized font. The contact information includes the company's address at 95 Yunhe St., New & High Tech Development Zone, Changchun, 130012, China, as well as phone numbers (86 431) 5100409 and (86431) 5173354, and email address dr@public.cc.jl.cn and website http://www.dirui.com.cn.
Assessment of Performance:
The performance of URISTIK H Series Reagent Strips For Urinalysis was studied in clinical laboratory settings by professional users. The strips were read visually and instrumentally using Dirui H Series Urine Analyzers. The results were compared to results obtained from Bayer MULTISTIX 10 SG Reagent Strips and from laboratory test methods. The studies demonstrated that professional users in centralized and point-of-care (POC) hospital, clinic, and doctor's office settings can obtain valid urinalysis test results.
Conclusion:
URISTIK H Series Reagent Strips For Urinalysis provide 11 reagent tests for urinalysis that are similar in composition and performance to reagent tests currently provided by devices on the U.S. market. URISTIK H Series Reagent Strips For Urinalysis are suitable for use in point-of-care (POC) settings. Dirui studies showed that the URISTIK H Series Reagent Strips For Urinalysis provide test results consistent with laboratory methods and performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips in POC settings.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The eagle is depicted in a simple, abstract style, with thick lines forming its body and wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 6 2004
Dirui Industrial Co., Ltd. c/o Mr. Joseph F. Ludford President U.S. Conformity Consultants, Inc. 7560 Lindbergh Drive Gaithersburg, MD 20879
K040703 Re:
Trade/Device Name: URISTIK H Series Reagent Strips Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Regulatory Class: Class: Class ::
Product Code: JIO, JIL, KQO, JRE, JMA, CEN, LJX, JMT, JIR, JIN, JJQ, CDM Dated: August 6, 2004 Received: August 23, 2004
Dear Mr. Ludford:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de nees mat have been require approval of a premarket approval application (PMA). and coomete / for ( 10 ) lear the device, subject to the general controls provisions of the Act. The r ou may, disrerere, mains of the Act include requirements for annual registration, listing of general controls profice, 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 it may 60 but 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 I'DA's issuance of a substantial equivalence determination does not mean r icase of advisou that I Drivisanthat your device complies with other requirements of the Act that I Dri has intate a word regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 comply with and the ring (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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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough maing of substantial equivalence of your device to a legally prematication. The Pice 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, If you destions on the promotion and advertising of your device, please contact the Office of of questions on the presise Evaluation and Safety at (301) 594-3084. Also, please note the In v are Diagnostic Dollywooding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may obtain 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,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, 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
5
Indications for Use
510(k) Number: K040703
Device Name: URISTIK H Series Reagent Strips
Indications For Use:
URISTIK H Series Reagent Strips provide qualitative and semi-quantitative tests for URISTIK H Senes Reagent Omps provide quotitions (acetoacetic acid), blood, protein, nitrite, ascorbic acid, pri, Specific gravity, Rotollios (es in urine. Tiest results may provide leukocytes, glucose, billiudin, and uroblikhogen in annel of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
Dirui H Series Reagent Strips are for single use in professional near-patient (point-of-Dirul H Series Reagent Stips are for Single as in professor.
care) and centralized laboratory locations. The strips are intended for use in screening care) and contrail200 is the following areas:
- Kidney function .
- Urinary tract infections .
- Carbohydrate metabolism (e.g. diabetes mellitus) .
- Liver function .
- Acid-base balance .
- Urine concentration .
Test results can be used along with other diagnostic information to rule out certain Test results can be doba along the mornscopic analysis is needed.
x Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
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) Caroll Seman Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 1 _
510(k) K040703