(261 days)
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No
The device description explicitly states that results are obtained by direct visual comparison with color blocks and that laboratory instrumentation is not required. There is no mention of any computational analysis or algorithms.
No
This device is an "in vitro" diagnostic tool used to test urine for various substances, providing information about certain bodily functions and potential disease states. It does not directly treat or prevent a disease.
Yes
The 'Intended Use / Indications for Use' section states that urine strips are for "in vitro" diagnostic use and their results "may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract infections," and "can be used along with other diagnostic information to rule out certain disease states."
No
The device description clearly states it is a physical plastic strip with reagent pads, which is a hardware component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the urine strips are for "in vitro diagnostic use."
- Purpose: The strips are used to test urine samples (which are taken from the body) to provide information about various bodily functions and potential health issues. This is a core characteristic of IVDs.
- Diagnostic Information: The results are intended to "provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract infections" and "can be used along with other diagnostic information to rule out certain disease states." This clearly indicates a diagnostic purpose.
- Near-patient and Centralized Laboratory Use: The intended use in both near-patient (point of care) and centralized laboratory settings further supports its role in diagnostic testing.
The description of the device and how it works (reagent pads reacting with urine to produce a visible color reaction) aligns with the typical function of an IVD test strip.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
JIL, JIO, CDM, JJB, JIN, JIR, JMT, LJX, CEN, JMA, JRE
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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
prescription use near-patient (point of care) and centralized laboratory locations.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Glucose: 75-125 mg/dl
Ketones: 5-10 mg/dl acetoacetic acid
Bilirubin: 0.4-0.8 mg/dl
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.
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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.
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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).
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§ 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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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, the
following information provides sufficient details to understand
the basis of a determination of substantial equivalence |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter
Name,
Address,
Contact | Wiener Laboratorios S.A.I.C.
Riobamba 2944
2000 - Rosario - Argentina
Tel: 54 341 4329191
Fax: 54 341 4851986
Contact person: Viviana Cétola
Date Prepared: 25th November 2008 |
| 2) Device name | Proprietary name: Wiener lab. Urine Strip
Common name: Urinary glucose (non quantitative) test system
Occult blood test
Classification names:
Regulatory Class I: JIN, JMT, CDM, JIR, JJB, LJX, CEN, JMA
Regulatory Class II: JIL, JIO
Device Class II |
1
.
:
:
.
.
510(k) Summary, Continued
,,
.
.
.
| 3) Predicate Device | We claim substantial equivalence to the currently marketed device
Bayer Multistix® 10SG reagents strips | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|------------------------|
| 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 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. | | |
| 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 equivalent
to other products in commercial-distribution intended for similar
use. Most notably it is substantially equivalent to the currently
marketed Bayer Multistix® 10 SG.
The following table illustrates the similarities and differences
between the Wiener lab. Urine Strip test system and the currently
marketed Bayer Multistix® 10 SG. | | |
| | | | |
| | BAYER Multistix®
10 SG | WIENER LAB.
Urine Strip | |
| | Intended use | For professional use | |
| | Intended
Specimen | Urine | |
| | Materials
Provided | Plastic strips affixed with several separate reagent
areas | |
| | Working
Temperature
Range | 15-30°C |