(261 days)
Urine strips are for "in vitro" diagnostic use and are intended for prescription use near-patient (point of care) and centralized laboratory locations.
Urine Strip includes test pads for qualitative and semi-quantitative determination of urobilinogen, glucose, ketones, bilirubin, proteins, nitrite, pH, blood, specific gravity, leukocytes and ascorbic acid in urine.
Urine test strips results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract infections. Test 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.
Wiener lab. Urine Strip are plastic strips to which glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, leucocytes and ascorbic acid reagents pads are affixed. The reagent pads react with the urine and provide a visible color reaction. The product is packaged in a plastic bottle. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. The instructions for use must be followed exactly. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. Laboratory instrumentation is not required.
The provided text is a 510(k) Summary for the "Wiener lab. Urine Strip" device. It outlines the device's intended use and claims substantial equivalence to the predicate device, Bayer Multistix® 10SG. However, it does not contain a study that explicitly details acceptance criteria and proves the device meets those criteria with specific performance metrics such as sensitivity, specificity, or accuracy.
The document focuses on:
- Device Description: What the device is and how it works.
- Intended Use: The diagnostic purposes of the device.
- Equivalencies and Differences to Predicate Device: A comparison of methodologies and sensitivities for each parameter with the predicate device.
Therefore, many of the requested details cannot be extracted from this specific document.
Here's the information that can be extracted or inferred from the provided text, along with what is missing:
1. A table of acceptance criteria and the reported device performance
The document lists "Sensitivity" for several parameters, comparing the Wiener lab. Urine Strip to the predicate device. While this indicates detection limits, it doesn't explicitly state "acceptance criteria" against which these sensitivities are being measured, nor does it present full performance metrics (like accuracy, specificity, etc.) typically found in a clinical study report.
| Parameter | Wiener lab. Urine Strip Sensitivity | Predicate Device (Bayer Multistix® 10SG) Sensitivity (for comparison) | Acceptance Criteria (Not Explicitly Stated as AC) |
|---|---|---|---|
| Proteins | 0.15-0.3 g/l (15-30 mg/dl) | (Not explicitly listed for predicate in this section) | Not explicitly stated |
| Blood | 150-620 µg/l (0.015-0.062 mg/dl) | (Not explicitly listed for predicate in this section) | Not explicitly stated |
| Nitrite | 0.05-0.15 mg/dl | 0.06-0.1 mg/dl | Not explicitly stated |
| Glucose | 100 mg/dl | 75-125 mg/dl | Not explicitly stated |
| Ketones | 5 mg/dl (acetoacetate) | 5-10 mg/dl (acetoacetic acid) | Not explicitly stated |
| Bilirubin | 0.5 mg/dl | 0.4-0.8 mg/dl | Not explicitly stated |
Missing:
- Explicitly defined acceptance criteria values for each performance metric. The document mentions "substantial equivalency" but does not define quantitative thresholds for this equivalency in terms of performance.
- Full device performance report (e.g., accuracy, sensitivity, specificity, PPV, NPV) against a defined ground truth for various concentrations for all analytes. The provided sensitivities are detection limits, not comprehensive performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing: This information is not provided in the 510(k) summary. The document does not describe a specific clinical study with a test set. It primarily compares the methodologies and stated sensitivities/detection limits to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing: This information is not provided. There is no mention of an expert panel or ground truth establishment process for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing: Not applicable, as no external test set or adjudication process is described in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Missing: Not applicable. The device is a chemical reagent strip read visually against color blocks, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Missing: Not applicable. The device is a chemical reagent strip, not an algorithm. Its performance is inherent in its chemical reactions and visual color change. The instructions state "Results are obtained by direct comparison of the test strip with the chemical-reaction and optical features of the reagent strip itself and comparison with color blocks. It is not an algorithm-only device."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing: The document does not describe a specific "ground truth" reference method for a clinical study. The comparison is based on the stated methodologies and sensitivities of the new device and the predicate device, implying that the performance claims are based on internal validation using established analytical methods rather than a head-to-head clinical trial with patient outcomes.
8. The sample size for the training set
Missing: The document does not describe a "training set" as this is not an algorithm-based device that undergoes machine learning training.
9. How the ground truth for the training set was established
Missing: Not applicable, as this is not an algorithm-based device.
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SEP - 2 2009
Wiener lab. Urine Strip
Image /page/0/Picture/3 description: The image is a circular logo with the text "Wiener lab." at the top. In the center of the logo is the text "ISO 9001" above a "TUV CERT" logo. The text "SISTEMA DE CALIDAD CERTIFICADO" is written around the perimeter of the circle. The logo appears to be a certification mark, possibly indicating that Wiener lab. meets the ISO 9001 quality management system standards.
Wiener lab.
Especialidades para Laboratorios Clínicos
WENER LABORATORIOS S.A.I.C. - Riobamba Phone +54 (341) 432-9181/6 - Fax +54 Internet: http://www.wiener
Section 6 - Summary
· 510(k) Summary "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92"
K083724 "The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________
| Introduction | According to the requirements of 21 CFR 862.1340, thefollowing information provides sufficient details to understandthe basis of a determination of substantial equivalence |
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| 1) SubmitterName,Address,Contact | Wiener Laboratorios S.A.I.C.Riobamba 29442000 - Rosario - ArgentinaTel: 54 341 4329191Fax: 54 341 4851986Contact person: Viviana CétolaDate Prepared: 25th November 2008 |
| 2) Device name | Proprietary name: Wiener lab. Urine StripCommon name: Urinary glucose (non quantitative) test systemOccult blood testClassification names:Regulatory Class I: JIN, JMT, CDM, JIR, JJB, LJX, CEN, JMARegulatory Class II: JIL, JIODevice Class II |
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510(k) Summary, Continued
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| 3) Predicate Device | We claim substantial equivalence to the currently marketed deviceBayer Multistix® 10SG reagents strips | ||
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| 4) Device description | Wiener lab. Urine Strip are plastic strips to which glucose, bilirubin,ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite,leucocytes and ascorbic acid reagents pads are affixed.The reagent pads react with the urine and provide a visible colorreaction.The product is packaged in a plastic bottle. Each strip is stable andready to use upon removal from the bottle. The entire reagent stripis disposable. The instructions for use must be followed exactly.Results are obtained by direct comparison of the test strip with thecolor blocks printed on the bottle label. Laboratory instrumentationis not required. | ||
| 5) intended use | Wiener lab. Urine Strip is intended for detection of glucose,bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen,nitrite, leucocytes and ascorbic acid in urine. | ||
| 6) Equivalencies and differences | The Wiener lab. Urine Strip test system is substantially equivalentto other products in commercial-distribution intended for similaruse. Most notably it is substantially equivalent to the currentlymarketed Bayer Multistix® 10 SG.The following table illustrates the similarities and differencesbetween the Wiener lab. Urine Strip test system and the currentlymarketed Bayer Multistix® 10 SG. | ||
| BAYER Multistix®10 SG | WIENER LAB.Urine Strip | ||
| Intended use | For professional use | ||
| IntendedSpecimen | Urine | ||
| MaterialsProvided | Plastic strips affixed with several separate reagentareas | ||
| WorkingTemperatureRange | 15-30°C | < 30°C | |
| Test Time | 30 seconds - 2 minutes | 60 seconds - 2 minutes |
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| GlucoseMethodology | Based on a sequential enzyme reaction. First, glucose oxidase catalyzes the formation of gluconic acid and hydrogen peroxide from the oxidation of glucose. Then, peroxidase catalyzes the reaction of hydrogen peroxide with potassium iodide to colors ranging from greenish light-blue through greenish-brown and then to brown | ||
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| BilirubinMethodology | Based on the bilirubin and dichloroanilyne diazonium cupping and produces a strongly acid medium | Based on the coupling of bilirubin with 2,4-dichlorophenyl diazonium salt in a strong acid medium | |
| KetoneMethodology | Based on the reaction of acetoacetic acid in urine with nitroprusside | ||
| SpecificGravityMethodology | Based on the pKa change. In the presence of urinary cations, protons are released from a polyelectrolyte producing a color change | ||
| BloodMethodology | Based on the peroxidase-like activity of hemoglobin, which catalyzes the reaction of diisopropylbenzene dihydroperoxide and 3,3', 5,5' tetramethylbenzidine | Based on the pseudoperoxidase activity of hemoglobin, which catalyzes the reaction of 3,3',5,5'- tetramethylbencidine with buffered organic hydroperoxide | |
| pHMethodology | Based on double indicator principle that gives a broad range of colors covering the entire urinary pH range | ||
| ProteinMethodology | Based on the color change of the indicator in the presence of proteins | ||
| UrobilinogenMethodology | Based on a modified Erlich reaction in which p-diethylaminobenzaldehyde in conjunction with a color enhacer reacts with urobilinogen in a strongly acidic medium | Based on the diazotization reaction of a diazonium salt and urinary urobilinogen in a strong acid medium | |
| NitriteMethodology | Based on the reaction of urinary nitrite and p-arsenilic acid, forming a diazonium compound. This compound reacts with 1,2,3,4-tetrahydrobenzo(h)quinolin e-3-ol | Based on the reaction of the p-arsanilic acid and nitrite, derived from a dietary nitrate in the presence of bacteria in urine, to form a diazonium compound. This compound reacts with N-(1-naphthyl)-ethylenediamine in an acidic medium | |
| LeucocytesMethodology | Granulocyte leucocytescontain esterases thatcatalyze the hydrolysis ofthe derivatized pyrrole thatreact with diazonium salt toproduce a purple color | Based on the presenceof granulocyteesterases. Theesterases cleave apyrazol ester derivativeto releasehydroxypyrazolderivative. Thisderivative reacts withdiazonium salt toproduce a purpleproduct. | |
| Sensitivity | Proteins: 0.15-0.3 g/l (15-30 mg/dl) | ||
| Blood: 150-620 µg/l(0.015-0.062 mg/dl) | |||
| Nitrite: 0.06-0.1 mg/dl | Nitrite: 0.05-0.15 mg/dl | ||
| Glucose: 75-125 mg/dl | Glucose: 100 mg/dl | ||
| Ketones: 5-10 mg/dlacetoacetic acid | Ketones: 5 mg/dlacetoacetate | ||
| Bilirubin: 0.4-0.8 mg/dl | Bilirubin: 0.5 mg/dl | ||
| 7) Conclusion | Above mentioned data show substantial equivalency to thepredicate device |
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird, with three wing-like strokes extending upwards and a tail-like element below. The logo is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Wiener Laboratorios S.A.I.C. c/o Dr. Viviana Cetola Quality Control/Quality Assurance Manager 2944 Riobamba Rosario, Santa Fe, Argentina 2000
2 2009
Re: K083724 Trade/Device Name: Urine Strip Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, CDM, JJB, JIN, JIR, JMT, LJX, CEN, JMA, JRE Dated: July 17, 2009 Received: July 22, 2009
Dear Dr Cetola:
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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/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,
G.C.H.
Courtney C. Harper, Ph.D. Acting 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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. Indication for Use
510(k) Number: K083724
Device Name: Urine Strip
Indication for Use: Urine strips are for "in vitro" diagnostic use and are intended for prescription use near-patient (point of care) and centralized laboratory locations.
Urine Strip includes test pads for qualitative and semi-quantitative determination of urobilinogen, glucose, ketones, bilirubin, proteins, nitrite, pH, blood, specific gravity, leukocytes and ascorbic acid in urine.
Urine test strips results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract infections. Test 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.
Prescription Use x_ And/Or Over the Counter Use_(21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C) IPLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
KOX
510(k) K083724
§ 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.