(45 days)
The ATAC-PAK Direct HDL Cholesterol Reagent Kit, the ATAC HDL-C Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of high density in serum. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders, atherosclerosis and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
The ATAC-PAK Direct HDL Cholesterol Reagent Kit, the ATAC HDL-C Calibrator and the ATAC 8000 Random Access Chemistry System are used as a system for the quantitative analysis of high density lipoprotein cholesterol (HDL-C) in serum. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease. The ATAC-PAK Direct HDL Cholesterol Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase after the selective removal non-HDL sources of cholesterol. The resulting increase in absorbance at 578 nm is proportional to the HDL cholesterol concentration in the sample.
Here's a breakdown of the acceptance criteria and study information for the ATAC-PAK Direct HDL Cholesterol Reagent Kit, ATAC HDL-C Calibrator, and ATAC 8000 Random Access Chemistry System:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity/Recovery | Linear range of 1 mg/dL to 150 mg/dL | Linear from 1 mg/dL to 150 mg/dL. |
| Regression R² value close to 1.0 (indicating strong linearity) | (ATAC Recoveries) = 1.8 mg/dL + 0.981 x (Standard Value), r² = 0.999. | |
| Low standard error of the estimate (sy.x) | sy.x = 1.77 mg/dL. | |
| Precision (Within-Run) | Low variability in repeated measurements of control sera | Serum control 1: Mean 29.8 mg/dL, within-run SD 1.76 mg/dL. Serum control 2: Mean 45.1 mg/dL, within-run SD 2.26 mg/dL. |
| Precision (Total) | Low overall variability in repeated measurements of control sera | Serum control 1: Mean 29.8 mg/dL, total SD 1.71 mg/dL. Serum control 2: Mean 45.1 mg/dL, total SD 2.23 mg/dL. |
| Method Comparison | Strong correlation with an accepted clinical method | y = 3.2 mg/dL + 0.938x (y = ATAC 8000 results, x = accepted clinical method). Correlation coefficient r = 0.969. |
| Detection Limit | Claimed detection limit of 1 mg/dL (or less) | Claimed 1 mg/dL. Observed detection limit (2 standard deviations of 22 replicate within-run precision study) = 0.66 mg/dL, which is below the claimed limit. |
| Reagent Stability | 14-day on-board reagent stability | Documented through assay of serum controls; ranges of HDL-cholesterol recoveries over the test period were less than 8 mg/dL, indicating stability. |
| Calibration Stability | 14-day calibration stability | Documented through assay of serum controls; ranges of HDL-cholesterol recoveries over the test period were less than 8 mg/dL, indicating stability. |
2. Sample Size Used for the Test Set and Data Provenance
- Linearity/Recovery: Regression statistics were based on standard recoveries ranging from 0.6 to 155.5 mg/dL. The number of unique standards is not explicitly stated, but di = 8 is mentioned, which often refers to the degrees of freedom in a regression, suggesting at least 9 data points.
- Precision:
- Serum control 1: n = 40 (replicates)
- Serum control 2: n = 40 (replicates)
- Method Comparison: One hundred and thirty-eight (n = 138) serum specimens.
- Detection Limit: 22 replicates were used for the within-run precision study to calculate the observed detection limit.
- Reagent and Calibration Stability: Not explicitly stated, but involved assays of "serum controls over the claimed periods."
Data Provenance:
The data provenance is not explicitly stated in terms of country of origin. The specimens for method comparison were "collected from adult patients," suggesting the data is retrospective as samples would have been collected prior to the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of device. This device is an in-vitro diagnostic (IVD) quantitative assay, where the "ground truth" is typically established by comparing its results to a validated reference method or known concentrations of analytes (standards/calibrators). There are no human "experts" establishing qualitative ground truth for diagnostic images or interpretations.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this device is a quantitative assay, not one requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a standalone in-vitro diagnostic device, not an imaging device or medical AI intended for human reader assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are all standalone performance evaluations of the ATAC-PAK Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator when used on the ATAC 8000 Random Access Chemistry System. The device performs the quantitative analysis automatically.
7. The Type of Ground Truth Used
- Linearity/Recovery: Known concentrations of linearity standards.
- Precision: Commercially available control sera with established target values.
- Method Comparison: Results from an "accepted clinical method" as the reference for comparison. While not explicitly defined, an "accepted clinical method" implies a well-established and validated laboratory method for HDL-C measurement.
- Detection Limit: A diluted HDL-C control and the statistical calculation based on its variability.
- Stability: Serum controls with known properties over time.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical reagent kit and an associated analyzer, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a system would involve method development and optimization by the manufacturer to achieve the stated performance specifications.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the development of the reagent and system would have been established through extensive chemical and analytical testing against reference materials and methods during its design and optimization phases.
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élan diagnostics
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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 Direct HDL Cholesterol Reagent Kit, the ATAC HDL-C Calibrator and the ATAC 8000 Random Access Chemistry System are used as a system for the quantitative analysis of high density lipoprotein cholesterol (HDL-C) in serum. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease.
The ATAC-PAK Direct HDL Cholesterol Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase after the selective removal non-HDL sources of cholesterol. The resulting increase in absorbance at 578 nm is proportional to the HDL cholesterol concentration in the sample.
The ATAC-PAK Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator are substantially equivalent to the Homogeneous Auto-Direct HDL-C Plus Reagent Kit, which is currently marketed by DMA, Inc.
The effectiveness of ATAC-PAK Direct HDL Cholesterol Reagent Kit and the ATAC HDL-C Calibrator used on the ATAC 8000 Random Access Chemistry System are shown by the following studies.
The recovery of HDL cholesterol using the ATAC-PAK Direct HDL Cholesterol Reagent is linear from 1 mg/dL to 150 mg/dL as shown by the recovery of linearity standards which span the claimed linear range. Regression statistics, comparing standard recoveries, which range from 0.6 to 155.5 mg/dL, to standard values are shown below.
(ATAC Recoveries) = 1.8 mg/dL + 0.981 x (Standard Value), r2 = 0.999. di = 8 sy.x = 1.77 mg/dL.
Precision, demonstrated by replicate assay of commercially available control sera, is shown below.
| Specimen | n | mean | within-run SD | total SD |
|---|---|---|---|---|
| Serum control 1 | 40 | 29.8 mg/dL | 1.76 mg/dL | 1.71 mg/dL |
| Serum control 2 | 40 | 45.1 mg/dL | 2.26 mg/dL | 2.23 mg/dL |
One hundred and thirty eight serum specimens, collected from adult patients, were assayed for HDL cholesterol using the ATAC 8000 Random Access Chemistry System and another accepted clinical method. Results ranging from 17 to 99 mg/dL were compared by least squares linear regression and the following statistics were obtained.
y = 3.2 mg/dL + 0.938x r = 0.969 y = ATAC 8000 results x = accepted clinical method
The detection limit claim of 1 mq/dL is documented through the repetitive assay of a diluted HDL-C control. The observed detection limit, calculated as two standard deviations of a 22 replicate within run precision study, is 0.66 mg/dL and is below the claimed limit.
The 14 day on board reagent stability and calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the ranges of HDL-cholesterol recoveries over the test than 8 mg/dL.
Wrynn Sterling
Wynn Stocking Manager of Requlatory Affairs Elan Diagnostics
510(k) Notification, ATAC-PAK Direct HDL Cholesterol Kit 21 May, 1999, p 49
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 9 1999
Mr. Wynn Stocking Manager. Regulatory Affairs Elan Diagnostics 231 N. Puente Street Brea, California 92821
Re: K991789
Trade Name: ATAC-PAK Direct HDL Cholesterol Reagent ATAC HDL-C Calibrator Kits Regulatory Class: I reserved Product Code: LBR Dated: May 21, 1999 Received: May 25, 1999
Dear Mr. Stocking:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 yontact 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Sutman
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
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510(k) Number (if known):
K99i789
Device Name:
ATAC-PAK Direct HDL Cholesterol Reagent and ATAC HDL-C Calibrator
Indications For Use:
The ATAC-PAK Direct HDL Cholesterol Reagent Kit, the ATAC HDL-C Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of high density in serum. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders, atherosclerosis and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
Respectfully,
Wynn Stocking Regulatory Affairs Manager Elan Diagnostics
21 May, 1999
Sean Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
(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)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.