(183 days)
Not Found
No
The device description details a chemical reaction-based assay for glucose measurement, and there is no mention of AI or ML in the provided text.
No.
The device is for the quantitative determination of glucose in human serum and plasma, used in the diagnosis and treatment of carbohydrate metabolism disorders, making it a diagnostic tool, not a therapeutic one that directly treats a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma." This indicates its use in diagnosing medical conditions.
No
The device description details a chemical reaction and measurement of absorbance, indicating a physical test system involving reagents and potentially hardware for measurement, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of glucose in human serum and plasma." This is a classic example of an in vitro test performed on biological samples taken from the human body.
- Diagnosis and Treatment: The intended use also mentions that the measurements are used in the "diagnosis and treatment of carbohydrate metabolism disorders," which is a key characteristic of IVD devices.
- Device Description: The description details a chemical reaction system that takes place outside the body (in vitro) to measure the analyte (glucose).
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GLICEMIA ENZIMATICA AA test system is intended to be used in the quantitative determination of glucose in human serum and plasma on both manual and automated systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Product codes (comma separated list FDA assigned to the subject device)
CGA
Device Description
End point method.
The Wiener lab. Glicemia enzimatica AA is based on the following reaction system:
Glucose + O2 + H2O →(GOD) Gluconic Acid + H2O2
2 H2O2 + 4-AP + 4-Hydroxybenzoate →(POD) red
The amount of glucose is determined by measuring the absorbance of this pigment
GOD (glucose oxidase) POD (peroxidase) 4-AP (4-aminophenazone).
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
Not Found
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)
The document provides comparative performance characteristics between the subject device (WIENER LAB. GLICEMIA ENZIMATICA AA test system) and the predicate device (DMA GLUCOSE test system).
Key comparative results are:
- Sample: Human serum, heparinized plasmas, potassium oxalate/fluoride and EDTA/fluoride plasmas (for both)
- Working Temperature Range: Manual: 15 - 37°C, Automated: 37°C (for Wiener Lab); 37°C (for DMA)
- Stability of final color: 30 minutes (for Wiener Lab); Not specified (for DMA)
- Wavelength of reading: 505 nm (for both)
- Calibration: Single point (for both)
- Linearity: 500 mg/dl (for Wiener Lab); 1000 mg/dl (for DMA)
- Minimum detection limit: 0.544 mg/dl (for Wiener Lab); 1.4 mg/dl (for DMA)
- Expected values: 70 - 110 mg/dl (70 - 105 mg/dl) (for Wiener Lab); 75 - 113 mg/dl (70 - 105 mg/dl) (for DMA)
- Intra-assay precision:
- Normal Serum Control: CV = 1.39% (for Wiener Lab); CV = 0.66% (for DMA)
- Abnormal Serum Control: CV = 1.11% (for Wiener Lab); CV = 0.58% (for DMA)
- Inter-assay precision:
- Normal Serum Control: CV = 1.92% (for Wiener Lab); CV = 1.22% (for DMA)
- Abnormal Serum Control: CV = 1.62% (for Wiener Lab); CV = 0.91% (for DMA)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics provided are related to precision (Intra-assay CV, Inter-assay CV), linearity, and minimum detection limit. Specific sensitivity, specificity, PPV, or NPV values are not provided.
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.
DMA (Data Medical Associates, Inc.) GLUCOSE (Oxidase) test system. K011953
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.
Not Found
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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DEC 21 2001
Image /page/0/Picture/1 description: The image is a circular logo or seal with the text "Wiener lab." at the top. Inside the circle, there is a symbol resembling an upside-down "W" above the text "ISO 9001". Below that, there is another logo with the text "TUV CERT". The text "SISTEMA DE CALIDAD CERTIFICADO" is written around the bottom half of the circle.
Image /page/0/Picture/2 description: The image shows the logo for Wiener lab. The logo consists of a stylized "W" inside a circle on the left, followed by the text "Wiener lab." in a bold, sans-serif font. Below the company name is the text "Especialidades para Laboratorios Clínicos" in a smaller font.
WIENER LABORATORIOS S.A.I.C. - Riobamba 2944 - 2000 Rosario - Argentina
Phone +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555
Internet:
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"
"The assigned 510(k) number is: كـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
Introduction
According to the requirements of 21 CFR 862.1580, the following information provides sufficient details to understand the basis of a determination of substantial equivalence.
Wiener Laboratorios S.A.I.C. 1) Submitter Riobamba 2944 Name, 2000 - Rosario - Argentina Address, Tel: 54 341 4329191 Contact Fax: 54 341 4851986 Contact person: Viviana Cétola Date Prepared: June 04, 2001
Continued on next page
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GLICEMIA LAB. WIENER 2) Device name Proprietary name: ENZIMATICA AA
Common name: Glucose test system.
Classification name: Glucose oxidase, glucose as per 21CFR section 862.1345.
Device Class II
- Predicate Device
We claim substantial equivalence to the currently (DMA) Data Medical Associates, Inc. marketed GLUCOSE (Oxidase) test system.
- Device description End point method.
The Wiener lab. Glicemia enzimatica AA is based on the following reaction system:
$$\text{Glucose} + \text{O}{2} + \text{H}{2}\text{O} \xrightarrow{\text{GOD}} \text{Gluconic Acid} + \text{H}{2}\text{O}{2}$$
$$2 \text{ H}{2}\text{O}{2} + \text{4-AP} + \text{4-Hydroxybenzoate} \xrightarrow{\text{POD}} \text{red}$$
The amount of glucose is determined by measuring the absorbance of this pigment
GOD (glucose oxidase) POD (peroxidase) 4-AP (4-aminophenazone).
Continued on next page
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- Intended use The GLICEMIA ENZIMATICA AA test system is intended to be used in the quantitative determination of glucose in human serum and plasma on both manual and automated systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism diabetes mellitus, neonatal including disorders hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
6) Equivalencies
The WIENER LAB. GLICEMIA ENZIMATICA AA test system is substantially equivalent to other products in Equivalorioloo of oyensial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed DMA GLUCOSE (oxidase) test system.
The following table illustrates the similarities and differences between the WIENER LAB. GLICEMIA ENZIMATICA AA test system and the currently marketed DMA GLUCOSA test system.
| | DMA
Test System | WIENER LAB.
Test System |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Intended use | Quantitative determination of glucose in
human serum and plasma. | |
| Test principle | End point method. | |
| | The principle is based on the following
reaction system:
$Glucose+O2+H2O ⟶GOD Gluconic Acid +H2O2$ $2 H2O2+4-AP+4-Hydroxybenzoate ⟶POD red quinonimine$ | |
| Essential
Components | GOD - POD -
Mutarotase - 4-AP
Hydroxybenzoate | GOD - POD - 4-AP
Hydroxybenzoate |
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:
11.000
| Calibrator and
| Serum Controls | Available - provided separately | |
|---|---|---|
| Instability or | ||
| deterioration of | ||
| reagents | Blank Absorbance |
0.300. | Blank Absorbance
0.160. |
| | Abnormal values of
controls. | Abnormally low
Standard
Absorbance. |
| Sample | Human serum, heparinized plasmas,
potassium oxalate/fluoride and
EDTA/fluoride plasmas | |
| Working
Temperature
Range | 37°C | Manual: 15 - 37°C
Automated: 37°C |
| Stability of final
color | Not specified | 30 minutes |
| Wavelength of
reading. | 505 nm | |
| Calibration | Single point | |
| Linearity | 1000 mg/dl | 500 mg/dl |
| Minimum
detection limit | 1.4 mg/dl | 0.544 mg/dl |
| Expected values | 75 - 113 mg/dl
(70 - 105 mg/dl) | 70 - 110 mg/dl
(70 - 105 mg/dl) |
| Intra-assay
precision | Normal Serum
Control:
CV = 0.66% | Normal Serum
Control:
CV = 1.39% |
| | Abnormal Serum
Control:
CV = 0.58% | Abnormal Serum
Control:
CV = 1.11% |
| Inter-assay
precision | Normal Serum Control:
CV = 1.22%
Abnormal Serum Control:
CV = 0.91% | Normal Serum Control:
CV = 1.92%
Abnormal Serum Control:
CV = 1.62% |
| | Sterility
conditions | Not required |
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4
7) Conclusion
Above mentioned data show substantial equivalency to the predicate device. ・
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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized, overlapping shapes that resemble a caduceus, a symbol often associated with healthcare.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 1 2001
Dr. Viviana Cétola QC/QA Manager Weiner Laboratorios S.A.I.C. 2944 Riobamba Rosario, Santa Fe, Argentina
Re: K011953
Trade/Device Name: Glicemia enzimatica AA Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA Dated: October 1, 2001 Received: October 9, 2001
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 10 more 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and it you finding of substantial equivalence of your device to a legally marketed nouncation. THE FDF Intention 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 1 II you desire specific across ic devices), please contact the Office of Compliance at additionally 007.10 for millionally, for questions on the promotion and advertising of your device, (301) 594-4500. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on your respondiations on 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 Sutman
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
7
CORR UNE
| 510(k) Number (if known): | K011953 |
|---|---|
| Device Name: | Wiener lab. |
| Glicemia enzimática AA |
Indications For Use:
The “Wiener lab. Glicemia enzimática AA” test system is intended to be The Wichel lub. Shoon a termination of glucose in human serum and both manual and automated Glucose systems. plasma on and treatment of the diagnosis measurements are used in diabetes carbohydrate metabolism disorders including mellitus, hypoglycemia, and of idiopathic neonatal hypoglycemia, and pancreatic islet cell carcinoma.
Jean Cooper
(Division Sign-
Division of Clire Laboratory Devices
510(k) Numbe: Kol1953
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NERDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)