(108 days)
The "Wiener lab. Mg-color AA" test system is a device 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).
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.
The provided document describes the 510(k) summary for the "Mg-Color AA" device, which is a magnesium test system. The equivalence to the predicate device (ROCHE MAGNESIUM test system) is established through a comparison of their characteristics and performance.
Here's an analysis of the provided information against your requested criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a predetermined threshold that the device must meet to be considered effective. Instead, it presents a comparison of the Wiener lab. Mg-Color AA system's performance characteristics against those of its predicate device, the ROCHE MAGNESIUM test system, to establish substantial equivalence. The implication is that if the Wiener lab. device's performance is comparable or marginally better/worse within acceptable limits for a similar device, it is deemed acceptable.
| Performance Characteristic | ROCHE Test System (Predicate Device) Reported Performance | WIENER LAB. Mg-Color AA Test System Reported Performance | Implied Acceptance Criterion (Substantial Equivalence) |
|---|---|---|---|
| Intended Use | Quantitative determination of magnesium in human serum, plasma and urine. | Quantitative determination of magnesium in human serum, plasma and urine. | To have the same intended use. |
| Test Principle | Magnesium, in the presence of EGTA, is coupled with xylidyl blue in an alkaline solution, forming a purple complex. EGTA complexes with calcium, so only magnesium reacts. Intensity of purple complex color is proportional to magnesium concentration and measured photometrically. | Magnesium, in the presence of EGTA, is coupled with xylidyl blue in an alkaline solution, forming a purple complex. EGTA complexes with calcium, so only magnesium reacts. Intensity of purple complex color is proportional to magnesium concentration and measured photometrically. | To use the same fundamental detection chemistry/principle. |
| Essential Components | Xylidyl blue - EGTA | Xylidyl blue - EGTA | To have the same essential reactive components. |
| Reagents | R1: Buffer/EGTA, R2: Xylidyl Blue | R: Buffer/EGTA/Xylidyl Blue | Different formulation (2 reagents vs. 1 reagent), but the components are the same. Acceptance based on overall equivalent performance despite formulation difference. |
| Reagent Handling | Ready to use | Ready to use | To be a ready-to-use reagent system. |
| Instability or deterioration of reagents | Not specified | Reagent decoloration or decreased pH | To have similar stability characteristics, or to identify potential instability indicators. |
| Sample | Serum, heparinized plasma and urine | Serum, heparinized plasma and urine | To be compatible with the same sample types. |
| Working Temperature Range | Not specified | 25 - 37°C | To operate within clinically relevant temperature ranges for such assays. |
| Stability of final color | Not specified | 60 minutes | To have a stable final color for photometric measurement. |
| Wavelength range of reading | 505-600 nm | 510 - 600 nm | To read within a comparable wavelength spectrum. 5nm difference is likely acceptable. |
| Calibration | Single point | Single point | To utilize the same calibration method. |
| Linearity | 4.86 mg/dl | 6.00 mg/dl | To demonstrate comparable or improved linearity range. (Wiener lab. shows wider linearity, which is usually considered an improvement). |
| Minimum detection limit | 0.07 mg/dl | 0.08 mg/dl | To have a comparable or marginally different detection limit. (Wiener lab. is slightly higher, but likely still clinically acceptable). |
| Expected values (Serum and plasma) | 1.58-2.55 mg/dl | 1.9-2.5 mg/dl | To fall within clinically acceptable reference ranges. |
| Expected values (Urine) | 60-210 mg/24 hs (4.10-13.80 mg/dl) | 50-150 mg/24 hs (1-10 mg/dl) | To fall within clinically acceptable reference ranges. |
| Intra-assay precision | Normal Serum Control: CV = 0.8% Abnormal Serum Control: CV = 0.7% Human Urine 1: CV = 3.2% Human Urine 2: CV = 0.6% | Normal Serum Control: CV = 2.0% Abnormal Serum Control: CV = 1.9% Human Urine 1: CV = 1.5% Human Urine 2: CV = 1.5% | To demonstrate comparable precision (within acceptable clinical limits). For serum controls, Wiener lab. has higher CVs, for urine, it's mixed. This would be evaluated for clinical acceptability. |
| 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% | To demonstrate comparable precision (within acceptable clinical limits). Wiener lab. has slightly higher CVs for serum controls and Human Urine 2, but lower for Human Urine 1. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document provides a general comparison table of characteristics and performance data but does not explicitly state the sample sizes used for the precision, linearity, or detection limit tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The submitter is Wiener Laboratorios S.A.I.C. based in Rosario, Argentina.
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)
This section is not applicable to this type of in vitro diagnostic (IVD) device. For IVDs like a magnesium test system, "ground truth" is typically established by reference methods, validated calibrators, and control materials with known concentrations, rather than expert consensus on diagnostic images. No human readers or experts are involved in establishing the "ground truth" for the test results themselves, beyond the analytical methods validating the control values.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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
Not applicable. This device is an in vitro diagnostic (chemical reagent system) and does not involve AI, human readers, or case interpretation in the way imaging devices do.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone chemical reagent system. Its performance (e.g., precision, linearity) is measured without human-in-the-loop performance influencing the result generation. A human operates the photometric instrument and interprets the final numerical value, but the chemical reaction and measurement are automated/standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For IVD devices like this, the "ground truth" for reported performance characteristics (e.g., precision, linearity, detection limits) would be established using:
- Certified reference materials/calibrators: For linearity and accuracy, the device's measurements are compared against samples with known, certified magnesium concentrations.
- Validated control materials: For precision, control samples with known (or tightly established) magnesium levels are repeatedly tested.
- Reference analytical methods: The results derived from the new device might be compared to a gold-standard or highly accurate reference method for magnesium measurement.
- Clinical correlation: The "expected values" are established through studies on healthy populations using validated methods.
The document implies these standard IVD validation practices by listing performance metrics, but doesn't detail the specifics of their establishment.
8. The sample size for the training set
Not applicable. This is an IVD reagent system, not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is an IVD reagent system, not an AI or machine learning device.
{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: http://www.wiener-lab.com.ar
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. TestSystem | |
|---|---|---|
| Intended use | Quantitative determination of magnesium in humanserum, plasma and urine. | |
| Test principle | Magnesium, in the presence of EGTA, is coupledwith xylidyl blue in an alkaline solution.$Mg + Xylidyl blue \longrightarrow purple complex$EGTA in the reagent complexes with calcium, sothat only magnesium react with the indicator. Theintensity of purple complex color formed isproportional to the magnesium concentration andcan be measured photometrically. | |
| EssentialComponents | Xylidyl blue - EGTA | |
| Reagents | R1: Buffer/EGTAR2: Xylidyl Blue | R: Buffer/EGTA/XylidylBlue |
| Reagenthandling | Ready to use | |
| Instability ordeterioration ofreagents | Not specified | Reagent decoloration ordecreased pH |
| Sample | Serum, heparinized plasma and urine | |
| WorkingTemperatureRange | 25 - 37°C | |
| Stability of finalcolor | Not specified | 60 minutes |
| Wavelengthrange of reading. | 505-600 nm | 510 -600 nm |
| Continued on next page | ||
| ROCHE Test System | WIENER LAB. TestSystem | |
| Calibration | Single point | |
| Linearity | 4.86 mg/dl | 6.00 mg/dl |
| Minimumdetection 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-assayprecision | 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 1CV = 3.2% | Human Urine 1CV = 1.5% | |
| Human Urine 2CV = 0.6% | Human Urine 2CV = 1.5% | |
| Inter-assayprecision | Normal Serum Control:CV = 1.6%Abnormal Serum Control:CV = 2.6%Human Urine 1CV = 6.3%Human Urine 2CV = 1.6% | Normal Serum Control:CV = 2.6%Abnormal Serum Control:CV = 3.3%Human Urine 1CV = 3.1%Human Urine 2CV = 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 + << << reserver in human serum, plasma and the quantitative determination of magness and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
Rute Chisler for Jean Corpu
(Division Sign-Off)
Division of Clinical Laboratory Devices
K012326
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
510(k) Number.
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
PROMOTION
§ 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.