(67 days)
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).
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 provided text describes the ATAC PAK Magnesium Reagent Kit, its intended use, and studies demonstrating its performance and substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabulated format. However, it presents performance metrics that implicitly serve as acceptance criteria by demonstrating equivalence to a legally marketed device and adequate performance for its intended use. Based on the provided data, the implicit acceptance criteria and the device's performance are summarized below:
| Performance Metric | Implicit Acceptance Criteria (based on predicate or desired performance) | Reported Device Performance |
|---|---|---|
| Linearity | Linear recovery over the usable range for magnesium determination. | Linear from 0.1 to 5.5 mEq/L. ATAC Recoveries = 0.0 mEq/dL + 0.983 x (Standard Value), r = 0.996, sY.x = 0.15 mEq/L, n = 36 |
| Precision (Within Run) | Low coefficient of variation (CV%) for replicate assays. | Serum 1: 1SD = 0.09 (8.8% CV) at 1.0 mEq/L |
| Serum 2: 1SD = 0.10 (5.2% CV) at 1.9 mEq/L | ||
| Serum 3: 1SD = 0.12 (4.1% CV) at 2.8 mEq/L | ||
| Precision (Total) | Low coefficient of variation (CV%) for replicate assays over time. | Serum 1: 1SD = 0.12 (12.0% CV) at 1.0 mEq/L |
| Serum 2: 1SD = 0.13 (7.1% CV) at 1.9 mEq/L | ||
| Serum 3: 1SD = 0.15 (5.4% CV) at 2.8 mEq/L | ||
| Method Comparison (Correlation with Predicate) | Good correlation with a commercially available method. | ATAC 8000 = 0.04 mEq/L + 0.964 x Competitive Reagent (Predicate: Beckman Synchron Magnesium Reagent, product 445360) |
| Range: 1.2 - 5.4 mEq/L, sY.x = 0.10 mEq/L | ||
| Detection Limit | Detection limit appropriate for clinical use. | 0.1 mEq/L (based on 30 replicate assay of diluted serum pool, SD = 0.02 mEq/L) |
| Onboard Reagent Stability | Stable for at least 8 hours. | Average changes in recovery less than 0.25 mEq/L over 8 hours. |
| Calibration Stability | Stable for at least 4 hours. | Average changes in recovery less than 0.05 mEq/L over 4 hours. |
Study Information:
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Sample sizes used for the test set and the data provenance:
- Linearity Study: n = 36 (for regression analysis of standards). The document does not specify the country of origin but implies laboratory-prepared standards.
- Precision Study: n = 60 replicates for each of the three serum samples. The control serum is commercially available, but its origin and whether the testing was prospective or retrospective are not specified.
- Method Comparison Study: n = 110 mixed serum and plasma specimens. These were collected from adult patients, implying a clinical setting. Country of origin not specified, and whether it was prospective or retrospective is not explicitly stated.
- Detection Limit Study: n = 30 replicates of a diluted serum pool.
- Stability Studies: Serum controls were assayed, but the specific number of samples or replicates for these studies is not provided beyond "average changes."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a quantitative assay for magnesium in serum and plasma, not an AI or imaging device that typically requires expert interpretation for a "ground truth" label.
- For the linearity study, the "ground truth" is the known concentration of the linearity standards.
- For the precision study, the "ground truth" is the mean concentration of the commercially available control serum.
- For the method comparison study, the "ground truth" is established by the results obtained from the legally marketed predicate device (Beckman Synchron Magnesium Reagent). No human experts are involved in establishing this "ground truth" in the context of this type of analytical method validation.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving subjective interpretation (e.g., radiology reads) where multiple human readers resolve disagreements. This product is an in-vitro diagnostic reagent, where results are quantitative measurements.
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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 is an in-vitro diagnostic (IVD) reagent kit, not an AI or imaging device where human readers interact with AI assistance. The study compares the new reagent's performance against a predicate device and its own analytical characteristics.
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If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
- Yes, the studies described are standalone performance evaluations of the ATAC PAK Magnesium Reagent Kit when used with the ATAC 8000 Random Access Chemistry System. This is a chemical assay, and its performance is assessed directly through its analytical capabilities without human-in-the-loop interaction for result generation. The human "in-the-loop" would be the laboratory personnel operating the instrument and interpreting the numerical results.
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The type of ground truth used:
- Reference standards/known concentrations for linearity.
- Assigned values/agreement with the predicate device for precision and method comparison.
- Experimental observation (e.g., standard deviation of replicates) for detection limit.
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The sample size for the training set:
- Not applicable. This is a chemical reagent kit, not an AI algorithm that requires a "training set" in the machine learning sense. The "development" of the reagent would involve chemical formulation and optimization, not data training.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an IVD reagent.
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MAR 1 0 2003
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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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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
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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
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OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.