(26 days)
Not Found
No
The device description and performance studies focus on standard chemical reaction principles and instrument performance, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic tool used for measuring magnesium concentration in serum, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia... and hypermagnesemia." It also mentions, "This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only." This clearly indicates its role in diagnosis.
No
The device description clearly states that the system consists of a chemistry instrument and an integrated Panel PC, indicating significant hardware components beyond just software. The software component (Panel PC) interacts with and controls the physical instrument.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only."
- Purpose: The device is intended for the "quantitative determination of magnesium concentration in serum," which is a biological sample taken from the body.
- Clinical Application: The results are used in the "diagnosis and treatment of hypomagnesemia and hypermagnesemia," indicating a clinical purpose.
- Setting: The intended users are "clinical laboratories or physician office laboratories," which are typical settings for in vitro diagnostic testing.
The description of the device and its function further supports its classification as an IVD, as it describes a chemical reaction performed on a serum sample to obtain a quantitative measurement for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JGJ
Device Description
Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample. A surfactant system is included to remove protein interference.
The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.
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
clinical laboratories or physician office laboratories.
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)
Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Axcel Clinical Chemistry System included precision, accuracy, and detection limit data.
Precision: In testing conducted at four magnesium levels for >=21 days, the within-run CV ranged from 1.9 to 6.7%, and total CV ranged from 2.8 to 7.5%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.2 to 5.4% and total CV ranged from 1.4 to 5.8%.
Accuracy: In the correlation study, 110 samples with magnesium values ranging from 0.4 to 5.5 mg/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9735, a standard error estimate of 0.14, a confidence interval slope of 1.000 to 1.092, and a confidence interval intercept of -0.28 to -0.08. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis yielded correlation coefficients of 0.9919 to 0.9959, standard error estimates of 0.09 to 0.14, confidence interval slopes of 1.001 to 1.086, and a confidence interval intercepts of -0.10 to 0.15.
Detection limit: The detection limit was 0.3 mg/dL.
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.
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.
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AUG 27 2012
| 22302
. .
510(k) SUMMARY
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC
4 Henderson Drive
West Caldwell, NJ 07006 | | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--|
| | Contact: | Hyman Katz, Ph.D.
Phone: 973-852-0158
Fax: 973-852-0237 | |
| Date Summary
Prepared: | July 27, 2012 | | |
| Device: | Trade Name: | ACE Magnesium Reagent | |
| | Classification: | Class I, reserved | |
| | Common/Classification Name: | Photometric Method, Magnesium
(21 C. F.R. § 862.1495)
Product Code JGJ | |
| Predicate
Devices: | Manufacturer for analyzer/reagent system predicate:
ACE Magnesium Reagent on the Alfa Wassermann ACE Axcel Clinical
Chemistry System (K113435) | | |
| Device
Descriptions: | Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to
produce a red complex which is measured bichromatically at 525 nm/692 nm.
The intensity of color produced is directly proportional to the magnesium
concentration in the sample. EGTA prevents calcium interference by preferential
chelation of calcium present in the sample. A surfactant system is included to
remove protein interference.
The ACE Axcel Clinical Chemistry System consists of two major components,
the chemistry instrument and an integrated Panel PC. The instrument accepts the
physical patient samples, performs the appropriate optical or potentiometric
measurements on those samples and communicates that data to an integral Panel
PC. The Panel PC uses keyboard or touch screen input to manually enter a variety
of data, control and accept data from the instrument, manage and maintain system
information and generate reports relative to patient status and instrument
performance. The Panel PC also allows remote download of patient requisitions
and upload of patient results via a standard interface. | | |
7/30/2012
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| Intended Use: | Indications for Use: |
|---|---|
| The ACE Magnesium Reagent is intended for the quantitative determination of | |
| magnesium concentration in serum using the ACE Axcel Clinical Chemistry | |
| System. Magnesium measurements are used in the diagnosis and treatment of | |
| hypomagnesemia (abnormally low serum levels of magnesium) and | |
| hypermagnesemia (abnormally high serum levels of magnesium). This test is | |
| intended for use in clinical laboratories or physician office laboratories. For in | |
| vitro diagnostic use only. | |
| Technological | |
| Characteristics: | The ACE Magnesium Reagent is composed of a single reagent bottle. The |
| reagent contains Xylidyl blue-1 and EGTA. | |
| The following is a description of the major features of the ACE Axcel Clinical | |
| Chemistry System: System throughput is approximately 160 test results per hour for routine, single reagent chemistries. System throughput will be higher when the test workload includes ISE's. The instrument has a capacity of 40 reagent containers on board. A reagent cooling system maintains the reagents at 12°C during instrument operation. Reagent containers are identified by computer coded labels to simplify system operation. All reagents in the system must include an identification label on the container. Sample and reagent sensing notify the operator of a depleted condition during operation. The system performs analysis at a reaction temperature of 37°C. An electrolyte subsystem capable of measuring sodium, potassium and chloride concentrations is included. Primary draw tubes may be introduced one at a time into the system for closed tube sampling. Positive tube identification can be achieved with an optional barcode scanner. An aliquot volume sufficient for all tests ordered is transferred and stored and the closed tube is returned to the user. Sample cups are introduced to the system one at a time or by sample ring segment. Disposable cuvettes are loaded in bulk and then automatically injected as needed by a cuvette hopper system. The ACE Axcel clinical chemistry optical system is capable of monitoring a maximum of 48 cuvettes at one time. The absorbance optical system is capable of absorbance measurements in a linear range of 0.0 to 2.0 absorbance units (at 0.67 cm pathlength). Sixteen wavelengths are measured simultaneously using a photodiode array. | |
| Performance | |
| Data: | Performance data for the Alfa Wassermann ACE Reagents run on the Alfa |
| Wassermann ACE Axcel Clinical Chemistry System included precision, | |
| accuracy, and detection limit data. | |
| ACE Magnesium Reagent | |
| Precision: In testing conducted at four magnesium levels for ≥21 days, the within- | |
| run CV ranged from 1.9 to 6.7%, and total CV ranged from 2.8 to 7.5%. In | |
| precision studies at three separate Physician Office Laboratory (POL) sites over 5 | |
| days, the within-run CV ranged from 1.2 to 5.4% and total CV ranged from 1.4 to | |
| 5.8%. | |
| Accuracy: In the correlation study, 110 samples with magnesium values ranging | |
| from 0.4 to 5.5 mg/dL were assayed on the Alfa Wassermann ACE Axcel | |
| Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical | |
| Chemistry System (x). Least squares regression analysis yielded a correlation | |
| coefficient of 0.9735, a standard error estimate of 0.14, a confidence interval | |
| slope of 1.000 to 1.092, and a confidence interval intercept of -0.28 to -0.08. In | |
| patient correlation studies at three separate POL sites, using the Alfa Wassermann | |
| ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE | |
| Clinical Chemistry System (x), least-squares regression analysis yielded | |
| correlation coefficients of 0.9919 to 0.9959, standard error estimates of 0.09 to | |
| 0.14, confidence interval slopes of 1.001 to 1.086, and a confidence interval | |
| intercepts of -0.10 to 0.15. | |
| Detection limit: The detection limit was 0.3 mg/dL. | |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data also |
| indicate substantial equivalence to the predicate device. |
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
ALFA WASSERMANN Diagnostic Technologies, Inc c/o Hyman Katz 4 Henderson Drive West Caldwell, NJ 07006
AUG 27 2012
Re: K122302
Trade Name: ACE Magnesium Reagent Regulation Number: 21 CFR §862.1495 Regulation Name: Magnesium test system Regulatory Class: Class I, reserved Product Codes: JGJ Dated: July 30, 2012 Received: August 1, 2012
Dear Dr. Katz:
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 (fix 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 productions including 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/Medical
Devices/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 Four may 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/Resourcesfor You/Industry/default.htm
Sincerely vours.
$\mathcal{V}$
Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
ු
510(k) Number (if known): ≤ 122302 ___________________________________________________________________________________________________________________________________________
Device Name: ACE Magnesium Reagent
Indications for Use:
The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use. (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In vitro Diagnostic Devices (OIVD)
Yung Chan
Division Sign-Off Office of In vitro Diagnostic Device Evaluation and Safety
510(k) K122302
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