(67 days)
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No
The summary describes a standard chemical assay for magnesium concentration and does not mention any AI or ML components.
No.
This device is an in vitro diagnostic reagent kit used for the quantitative determination of magnesium levels, which aids in diagnosis. It does not directly treat or alleviate a disease or condition.
Yes
The Intended Use / Indications for Use section explicitly states that "Magnesium results are 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 role in diagnosing medical conditions.
No
The device description clearly states it is a "Reagent Kit" and describes a chemical reaction involving "xylidyl blue" and "absorbance at 510 nm," indicating a physical chemical component, not 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 magnesium in serum and plasma." Serum and plasma are biological specimens taken from the human body.
- Purpose: The results are used for the "diagnosis and treatment of hypomagnesemia and hypermagnesemia." This indicates the device is used to provide information for medical diagnosis and treatment decisions.
- Device Description: It describes a reagent kit that interacts with a biological sample (serum and plasma) to produce a measurable result (absorbance at 510 nm) that is proportional to the concentration of an analyte (magnesium) in the sample.
- Care Setting: It is intended for use by "trained personnel in a professional setting," which is typical for IVD devices used in clinical laboratories.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The ATAC PAK Magnesium Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results are used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
Product codes
JGJ
Device Description
The ATAC PAK Magnesium Reagent Kit is intended for the quantitative determination of magnesium in serum and plasma. Magnesium results are used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). The ATAC PAK Magnesium Reagent determines magnesium through its selective binding by xylidyl blue to form a red-purple chelate. The resulting increase in absorbance at 510 nm is proportional to the magnesium concentration in the sample.
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
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
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
The recovery of magnesium using the ATAC PAK Magnesium Reagent is linear from 0.1 to 5.5 mEq/L, as shown by the recovery of linearity standards that span the usable range. Regression statistics compare standard values. These statistics are shown below.
ATAC Recoveries = 0.0 mEq/dL + 0.983 x (Standard Value), r = 0.996, sY.x = 0.15 mEq/L, n = 36
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.
| Sample | n | mean | Within Run 1SD | Within Run %CV | Total 1SD | Total %CV |
|---|---|---|---|---|---|---|
| Serum 1 | 60 | 1.0 | 0.09 | 8.8% | 0.12 | 12.0% |
| Serum 2 | 60 | 1.9 | 0.10 | 5.2% | 0.13 | 7.1% |
| Serum 3 | 60 | 2.8 | 0.12 | 4.1% | 0.15 | 5.4% |
Mixed serum and plasma specimens, collected from adult patients, were assayed for magnesium using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
ATAC 8000 = 0.04 mEq/L + 0.964 x Competitive Reagent range = 1.2 - 5.4 mEq/L s_v.x = 0.10 mEq/L n = 110
The detection limit of 0.1 mEg/L is documented through the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.02 mEq/L. Consequently, the detection limit is reported as 0.1 mEq/L, which is the round-off error of the assay.
The 8 hour onboard reagent stability and 4 hour calibration stability claims are documented through the assay of serum controls over the claimed periods. The average changes in recovery are less than 0.25 mEqL over the 8 hour onboard claim and less than 0.05 mEq/L over the 4 hour calibration stability claim.
Key Metrics
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Predicate Device(s)
Beckman Synchron Magnesium Reagent, product 445360
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Image /page/0/Picture/0 description: The image shows a handwritten string of characters, which appears to be a code or identifier. The characters are 'K030010', with a mix of uppercase letters and numerical digits. The handwriting is somewhat stylized, with rounded shapes for the 'O' and '0' characters, and a distinct form for the 'K'.
MAR 1 0 2003
Image /page/0/Picture/2 description: The image shows the word "élan" in a stylized font. The "é" has a unique design, with a small, textured, diamond-like shape above it. The rest of the letters are in a flowing, cursive style. The entire word is in black and set against a white background.
1075 W. Lambert Road Building D Brea, California 92821 T (714) 672 3553 F (714) 672 3554
SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION
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.
The ATAC PAK Magnesium Reagent Kit is intended for the quantitative determination of magnesium in serum and plasma. Magnesium results are used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). The ATAC PAK Magnesium Reagent determines magnesium through its selective binding by xylidyl blue to form a red-purple chelate. The resulting increase in absorbance at 510 nm is proportional to the magnesium concentration in the sample.
The ATAC PAK Magnesium Reagent Kit is substantially equivalent to the Beckman Synchron Magnesium Reagent, product 445360, which is currently marketed by Beckman Coulter, Inc. of Brea, CA. The effectiveness of ATAC PAK Magnesium Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
The recovery of magnesium using the ATAC PAK Magnesium Reagent is linear from 0.1 to 5.5 mEq/L, as shown by the recovery of linearity standards that span the usable range. Regression statistics compare standard values. These statistics are shown below.
$$\text{ATAC Rewveries} = 0.0 \text{ mEq/dL} + 0.983 \times \text{(Standard Value)}, \quad \text{r} = 0.996, \quad s_{\text{Y.x}} = 0.15 \text{ mEq/L}, \quad n = 36$$
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.
| Sample | n | mean | Within Run | Total | ||
|---|---|---|---|---|---|---|
| 1SD | %CV | 1SD | %CV | |||
| Serum 1 | 60 | 1.0 | 0.09 | 8.8% | 0.12 | 12.0% |
| Serum 2 | 60 | 1.9 | 0.10 | 5.2% | 0.13 | 7.1% |
| Serum 3 | 60 | 2.8 | 0.12 | 4.1% | 0.15 | 5.4% |
Mixed serum and plasma specimens, collected from adult patients, were assayed for magnesium using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
ATAC 8000 = 0.04 mEq/L + 0.964 x Competitive Reagent range = 1.2 - 5.4 mEq/L $s_{v.x}$ = 0.10 mEq/L n = 110
The detection limit of 0.1 mEg/L is documented through the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.02 mEq/L. Consequently, the detection limit is reported as 0.1 mEq/L, which is the round-off error of the assay.
The 8 hour onboard reagent stability and 4 hour calibration stability claims are documented through the assay of serum controls over the claimed periods. The average changes in recovery are less than 0.25 mEqL over the 8 hour onboard claim and less than 0.05 mEq/L over the 4 hour calibration stability claim.
Wynn Stocking
Manager of Regulatory Affairs Elan, Brea California
510(k) Notification, ATAC PAK Magnesium Reagent Kit, 31 December, 2002, p 47
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 0 2003
Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road - Building D Brea. CA 92821
Re: K030010
Trade/Device Name: ATAC PAK Magnesium Reagent Regulation Number: 21 CFR 862.1495 Regulation Name: Magnesium test system Regulatory Class: Class I Product Code: JGJ Dated: December 31, 2002 Received: January 2, 2003
Dear Mr. Stocking:
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,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name:
ATAC PAK Magnesium Reagent
Indications for Use:
The ATAC PAK Magnesium Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results are used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean Cooper
Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)