(10 days)
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No
The summary describes a chemical reagent kit and an analyzer for quantitative determination of magnesium. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on analytical performance metrics like linearity, detection limit, precision, and correlation, which are standard for in vitro diagnostic assays and do not suggest the use of AI/ML.
No
This device is a reagent kit used for the quantitative determination of magnesium levels in serum and plasma, which aids in diagnosis. It does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Magnesium results may be used for the diagnosis and treatment of hypomagnesemia ... and hypermagnesemia." This indicates its role in identifying or characterizing a disease or condition.
No
The device described is a reagent kit intended for use with a specific analyzer (Vitalab Selectra Analyzer) to perform a chemical test. This involves physical components (the reagent) and a hardware analyzer, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of magnesium in serum and plasma." Serum and plasma are biological specimens taken from the human body.
- Diagnostic Purpose: The intended use also states that the results "may be used for the diagnosis and treatment of hypomagnesemia... and hypermagnesemia." This clearly indicates a diagnostic purpose.
- In Vitro: The method described involves a reagent reacting with the biological sample (serum and plasma) outside of the body ("in vitro").
- Device Description: The description details a "reagent" used with an "analyzer," which are typical components of an in vitro diagnostic system.
Therefore, based on the provided information, the Vitalab Magnesium Reagent Kit meets the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vitalab Magnesium Reagent Kit is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of magnesium in serum and plasma. Magnesium results may be used for 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
The Vitalab Magnesium Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines magnesium through chelation by xylidyl blue producing a colored complex.
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
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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 linear range of the Vitalab Magnesium Reagent is from 0.1 to at least 5.0 mg/dL, as shown by the Usable Range: recovery of linearity related solutions that span the linear range. Least squares regression statistics, forced through the origin, compare recoveries to standard concentrations.
(Vitalab Recoveries) = 0 mg/dL + 0.883 x (Reference), r = 0.997, sxx = 0.10 mg/dL, n = 55
Detection Limit: Normal saline was assayed thirty times in a single analytical run. The mean and started on organisand was steplation and start the results are both 0.0 mg/dL. The minimum detection limit, calculated as the mean plus two standad the results are oour overy values, is rounded up to 0.1 mg/dL, which is the round off error of the test.
Precision: Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
Serum 1: n=60, mean=1.2, Within Run 1SD=0.03, Within Run %CV=2.2%, Total 1SD=0.4, Total %CV=3.2%
Serum 2: n=60, mean=2.2, Within Run 1SD=0.02, Within Run %CV=0.8%, Total 1SD=0.3, Total %CV=1.1%
Serum 3: n=60, mean=3.3, Within Run 1SD=0.02, Within Run %CV=0.7%, Total 1SD=0.3, Total %CV=1.0%
Correlation: Fifty eight serum specimens ranging from 1.5 to 5.2 mg/dL magnesium and 60 heparinized plasma specimens ranging from 1.5 to 2.8 mg/dL magnesium were collected from adult patients and were assayed for magnesium using the Vitalab Selectra E Analyzer and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
Selectra = 0.3 mg/dL + 0.889 x Competitive Reagent syx = 0.04 mg/dL range = 1.5 - 5.2 mg/dL n = 118
Stability: The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, statistical estimates of total imprecision are less than 0.1 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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§ 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
Brea, CA 92821 F (714) 672-3554 T (714) 672-3553
Summary of 510(k) Safety and Effectiveness Information Vitalab Magnesium Reagent
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitted by:
| Clinical Data, Inc.
1075 West Lambert Road, Building D
| Brea, California 92861 | |
|---|---|
| Contact Person: | Wynn Stocking |
| Regulatory Affairs Manager | |
| Date Submitted: | February 4, 2004 |
Device Names:
| Proprietary name: | Vitalab Magnesium Reagent |
|---|---|
| Common name: | Magnesium reagent |
| Classification Name: | Photometric method, magnesium |
Device Description:
The Vitalab Magnesium Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines magnesium through chelation by xylidyl blue producing a colored complex.
Intended Use:
The Vitalab Magnesium Reagent Kit is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of magnesium in serum and plasma. Magnesium results may be used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
Predicate Device:
Vitalab Magnesium Reagent Kit is substantially equivalent to the Roche Magnesium Reagent, product no. 11489330, which is currently marketed by Roche Diagnostics Corp. of Indianapolis, IN
Summary of Performance Data:
The linear range of the Vitalab Magnesium Reagent is from 0.1 to at least 5.0 mg/dL, as shown by the Usable Range: recovery of linearity related solutions that span the linear range. Least squares regression statistics, forced through the origin, compare recoveries to standard concentrations.
(Vitalab Recoveries) = 0 mg/dL + 0.883 x (Reference), r = 0.997, sxx = 0.10 mg/dL, n = 55
510(k) Notification, Vitalab Magnesium Reagent Kit - Additional Information Clinical Data, Brea, California
February 4, 2004 Page 49
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- Detection Limit: Normal saline was assayed thirty times in a single analytical run. The mean and started on organisand was steplation and start the results are both 0.0 mg/dL. The minimum detection limit, calculated as the mean plus two standad the results are oour overy values, is rounded up to 0.1 mg/dL, which is the round off error of the test.
- Precision is demonstrated by the replicate assay of commercially available control serum. Precision Precision: statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
| Sample | n | mean | Within Run | Total | ||
|---|---|---|---|---|---|---|
| 1SD | %CV | 1SD | %CV | |||
| Serum 1 | 60 | 1.2 | 0.03 | 2.2% | 0.4 | 3.2% |
| Serum 2 | 60 | 2.2 | 0.02 | 0.8% | 0.3 | 1.1% |
| Serum 3 | 60 | 3.3 | 0.02 | 0.7% | 0.3 | 1.0% |
Fifty eight serum specimens ranging from 1.5 to 5.2 mg/dL magnesium and 60 heparinized plasma Correlation: specimens ranging from 1.5 to 2.8 mg/dL magnesium were collected from adult patients and were assayed for magnesium using the Vitalab Selectra E Analyzer and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
Selectra = 0.3 mg/dL + 0.889 x Competitive Reagent syx = 0.04 mg/dL range = 1.5 - 5.2 mg/dL n = 118
- The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the Stability: assay of serum controls over the claimed periods. In all cases, statistical estimates of total imprecision are less than 0.1 mg/dL.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR - 8 2004
Clinical Data, Inc. c/o: Mr. Ned E. Devine, Jr. Entela, Inc 3033 Madison Avenue, SE Grand Rapids, MI 49548
Re: K040508
Trade/Device Name: Vitalab Magnesium Reagent Regulation Number: 21 CFR 862.1495 Regulation Name: Magnesium test system Regulatory Class: Class I Product Code: JGJ Dated: February 27, 2004 Received: February 27, 2004
Dear Mr. Devine:
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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device. please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Image /page/4/Picture/1 description: The image contains a sequence of alphanumeric characters, specifically "K040508". The characters are written in a bold, sans-serif font, and they appear to be handwritten. A horizontal line is present beneath the sequence of characters.
Device Name:
Vitalab Magnesium Reagent
Indications for Use:
The Vitalab Magnesium Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results may be used for the diagnosis and treatment of hypomagnesemia (abnomally low plasma levels of magnesium) and hypermagnesemia (abnomally high plasma levels of magnesium).
prescription
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C. Benam
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040508