(108 days)
ROCHE MAGNESIUM test system (Cat. Nº 1489330)
Not Found
No
The device description details a chemical reaction and photometric measurement, with no mention of AI or ML.
No
Explanation: This device is for diagnostic purposes (measuring magnesium levels) and does not treat or alleviate a disease or condition.
Yes
The device is used for the "diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium)." This clearly indicates its diagnostic purpose.
No
The device description clearly outlines a chemical reaction and photometric measurement, indicating a hardware-based laboratory test system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "quantitative determination of magnesium in human serum, plasma and urine." This involves testing samples taken from the human body, but the testing itself is performed outside the body (in vitro).
- Diagnostic Purpose: The intended use also states that the measurements are "used in the diagnosis and treatment of hypomagnesemia... and hypermagnesemia..." This clearly indicates a diagnostic purpose.
- Device Description: The description details a chemical reaction that occurs with the sample in vitro to produce a measurable result.
These characteristics align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mg-COLOR AA reagent is intended to be used in the quantitative determination of magnesium in human serum, plasma and urine. Magnesium measurement are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
Product codes (comma separated list FDA assigned to the subject device)
JGJ
Device Description
Magnesium, in the presence of EGTA, is coupled with xylidyl blue in an alkaline solution.
Mg + Xylidyl blue -> purple complex
EGTA in the reagent complexes with calcium, so that only magnesium react with the indicator. The intensity of purple complex color formed is proportional to the magnesium concentration and can be measured photometrically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photometric method
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
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)
Comparison of Wiener lab. Magnesium test system and ROCHE MAGNESIUM test system based on:
Intended use: Quantitative determination of magnesium in human serum, plasma and urine.
Test principle: Magnesium, in the presence of EGTA, is coupled with xylidyl blue in an alkaline solution. Mg + Xylidyl blue -> purple complex. EGTA in the reagent complexes with calcium, so that only magnesium react with the indicator. The intensity of purple complex color formed is proportional to the magnesium concentration and can be measured photometrically.
Essential Components: Xylidyl blue - EGTA
Reagents: ROCHE: R1: Buffer/EGTA, R2: Xylidyl Blue; WIENER LAB.: R: Buffer/EGTA/Xylidyl Blue
Reagent handling: Ready to use
Instability or deterioration of reagents: ROCHE: Not specified; WIENER LAB.: Reagent decoloration or decreased pH
Sample: Serum, heparinized plasma and urine
Working Temperature Range: 25 - 37°C
Stability of final color: WIENER LAB.: 60 minutes
Wavelength range of reading: 505-600 nm for ROCHE; 510 -600 nm for WIENER LAB.
Calibration: Single point
Linearity: ROCHE: 4.86 mg/dl; WIENER LAB.: 6.00 mg/dl
Minimum detection limit: ROCHE: 0.07 mg/dl; WIENER LAB.: 0.08 mg/dl
Expected values:
Serum and plasma: ROCHE: 1.58-2.55 mg/dl; WIENER LAB.: 1.9-2.5 mg/dl
Urine: ROCHE: 60-210mg/24 hs, 4.10-13.80 mg/dl; WIENER LAB.: 50-150 mg/24 hs, 1-10 mg/dl
Intra-assay precision (CV):
Normal Serum Control: ROCHE: 0.8%; WIENER LAB.: 2.0%
Abnormal Serum Control: ROCHE: 0.7%; WIENER LAB.: 1.9%
Human Urine 1: ROCHE: 3.2%; WIENER LAB.: 1.5%
Human Urine 2: ROCHE: 0.6%; WIENER LAB.: 1.5%
Inter-assay precision (CV):
Normal Serum Control: ROCHE: 1.6%; WIENER LAB.: 2.6%
Abnormal Serum Control: ROCHE: 2.6%; WIENER LAB.: 3.3%
Human Urine 1: ROCHE: 6.3%; WIENER LAB.: 3.1%
Human Urine 2: ROCHE: 1.6%; WIENER LAB.: 1.9%
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.
ROCHE MAGNESIUM test system (Cat. Nº 1489330)
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
§ 862.1495 Magnesium test system.
(a)
Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).(b)
Classification. Class I.
0
NOV 0 9 2001
Image /page/0/Picture/2 description: The image is a black and white circular seal. The seal contains the text "Wiener lab." at the top, "SISTEMA DE CALIDAD CERTIFICADO" around the bottom, and "ISO 9001" in the center. There is a logo above the text "ISO 9001" and "TUV CERT" below it.
Image /page/0/Picture/3 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 bold, sans-serif font. Below the company name is the text "Especialidades para Laboratorios Clínicos" in a smaller font size.
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: ______________________________________________________________________________________________________________________________________________
According to the requirements of 21 CFR 862.1495, the Introduction following information provides sufficient details to understand the basis of a determination of substantial equivalence.
Wiener Lab Group 1) Submitter name, Riobamba 2944 address, contact 2000 - Rosario - Argentina
Contact person: Viviana Cétola
Date Prepared: March 20, 2001
Proprietary name: Mg-Color AA 2) Device name
Common name: Magnesium test system
Classification name: Photometric method, Magnesium as per 21 CFR Section 862.1495 Device Class I
1
- Predicate Device We claim substantial equivalence to the currently marketed ROCHE MAGNESIUM test system (Cat. Nº 1489330).
Magnesium, in the presence of EGTA, is coupled with xylidyl 4) Device blue in an alkaline solution. descriptions
-- ► purple complex Mg + Xylidyl blue
EGTA in the reagent complexes with calcium, so that only magnesium react with the indicator. The intensity of purple complex color formed is proportional to the magnesium concentration and can be measured photometrically.
The Mg-COLOR AA reagent is intended to be used in the 5) Intended use quantitative determination of magnesium in human serum, plasma and urine. Magnesium measurement are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
The Wiener lab. Magnesium test system is substantially 6) Equivalencies equivalent to other products in commercial distribution and differences intended for similar use. Most notably it is substantially equivalent to the currently marketed ROCHE MAGNESIUM test system.
The following table illustrates the similarities and differences between the Wiener lab. Magnesium test system and the currently market ROCHE MAGNESIUM test system.
2
| | ROCHE Test System | WIENER LAB. Test
System |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Quantitative determination of magnesium in human
serum, plasma and urine. | |
| Test principle | Magnesium, in the presence of EGTA, is coupled
with xylidyl blue in an alkaline solution.
$Mg + Xylidyl blue \longrightarrow purple complex$
EGTA in the reagent complexes with calcium, so
that only magnesium react with the indicator. The
intensity of purple complex color formed is
proportional to the magnesium concentration and
can be measured photometrically. | |
| Essential
Components | Xylidyl blue - EGTA | |
| Reagents | R1: Buffer/EGTA
R2: Xylidyl Blue | R: Buffer/EGTA/Xylidyl
Blue |
| Reagent
handling | Ready to use | |
| Instability or
deterioration of
reagents | Not specified | Reagent decoloration or
decreased pH |
| Sample | Serum, heparinized plasma and urine | |
| Working
Temperature
Range | | 25 - 37°C |
| Stability of final
color | Not specified | 60 minutes |
| Wavelength
range of reading. | 505-600 nm | 510 -600 nm |
| | | Continued on next page |
| | ROCHE Test System | WIENER LAB. Test
System |
| Calibration | Single point | |
| Linearity | 4.86 mg/dl | 6.00 mg/dl |
| Minimum
detection limit | 0.07 mg/dl | 0.08 mg/dl |
| Expected values | Serum and plasma:
1.58-2.55 mg/dl | Serum and plasma:
1.9-2.5 mg/dl |
| | Urine:
60-210mg/24 hs | Urine:
50-150 mg/24 hs |
| | 4.10-13.80 mg/dl | 1-10 mg/dl |
| Intra-assay
precision | Normal Serum Control:
CV = 0.8% | Normal Serum Control:
CV = 2.0% |
| | Abnormal Serum Control:
CV = 0.7% | Abnormal Serum Control:
CV = 1.9% |
| | Human Urine 1
CV = 3.2% | Human Urine 1
CV = 1.5% |
| | Human Urine 2
CV = 0.6% | Human Urine 2
CV = 1.5% |
| Inter-assay
precision | Normal Serum Control:
CV = 1.6%
Abnormal Serum Control:
CV = 2.6%
Human Urine 1
CV = 6.3%
Human Urine 2
CV = 1.6% | Normal Serum Control:
CV = 2.6%
Abnormal Serum Control:
CV = 3.3%
Human Urine 1
CV = 3.1%
Human Urine 2
CV = 1.9% |
.
3
.
4
Based on the data above mentioned, we believe that the 7) Conclusion Based on the data above none support substantial equivalence to extended claims commercial distribution intended for similar use
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three figures in profile facing right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Viviana Cetola OC/OA Manager Wiener Laboratorios S. A. I.C. Riobamba 2944. Rosario, Santa Fe Argentina
NOV 0 9 2001
Re: K012326
Trade/Device Name: Mg-color AA Regulation Number: 21 CFR 862.1495 Regulation Name: Magnesium test system Regulatory Class: Class I, reserved Product Code: JGJ 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 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 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 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (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 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.
Steven Butman
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
NOV 0 9 2001
Page_Lof_1_
| 510(k) Number (if known): | K012326 |
|---|---|
| Device Name: | Wiener lab. |
| Mg-coler AA |
Indications For Use:
The "Wiener lab. Mg-color AA" test system is a device intended to be used in The Vierler lab. Mg oolor 7 +