(57 days)
The ATAC Direct HDL Cholesterol Reagent Kit and the ATAC HDL-C Calibrator are intended for the quantitative determination of high density lipoprotein cholesterol in serum on the ATAC 6000 Chemistry Analyzer. 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 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.
Acceptance Criteria and Device Performance for ATAC Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator
The ATAC Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator are intended for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum on the ATAC 6000 Chemistry Analyzer. HDL-C 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.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity | Good correlation (r² close to 1) between standard recoveries and standard values across the measuring range. | r² = 0.999 for recoveries ranging from 1.4 to 174 mg/dL. Regression equation: (ATAC Recoveries) = 1.9 mg/dL + 1.074 x (Standard Value). sv.x = 1.62 mg/dL. |
| Precision | Low %CV for both within-run and total precision. | Within Run:- Serum 1 (mean 35.4 mg/dL): 1SD = 0.84, %CV = 2.4%- Serum 2 (mean 45.1 mg/dL): 1SD = 0.89, %CV = 2.0%Total:- Serum 1 (mean 32.7 mg/dL): 1SD = 2.47, %CV = 7.6%- Serum 2 (mean 45.1 mg/dL): 1SD = 3.30, %CV = 7.3% |
| Method Comparison | Strong correlation with an accepted clinical method. | y = - 2.4 mg/dL + 1.077x (where y = ATAC 6000 results, x = accepted clinical method). Correlation coefficient (r) = 0.962. |
| Detection Limit | Claimed detection limit of 2 mg/dL should be met or exceeded by observed detection limit. | Observed detection limit = 1.3 mg/dL. This is below the claimed limit of 2 mg/dL, indicating the device meets the criterion. |
2. Sample Sizes and Data Provenance
- Test Set (Method Comparison): 131 serum specimens.
- Data Provenance: The specimens were collected from adult patients. The country of origin is not explicitly stated, but the submission is from Elan Diagnostics in Brea, California, USA, suggesting the data is likely from the USA. The study design appears to be prospective due to the nature of comparing a new device against an existing method using collected specimens, though the exact timing of collection relative to the study is not specified in detail.
- Test Set (Linearity): 8 linearity standards.
- Test Set (Precision - Within Run): 22 replicates for each of 2 control sera.
- Test Set (Precision - Total): 40 replicates for each of 2 control sera.
- Test Set (Detection Limit): 22 replicates of a diluted HDL-C control.
3. Number of Experts and Qualifications for Ground Truth
Not applicable for this type of in vitro diagnostic device study. The ground truth for chemical analytes like HDL-C is established through reference methods or precisely prepared standards, not typically through human expert consensus in the same way an imaging or clinical diagnostic algorithm would be.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth for these studies relies on analytical measurements rather than expert human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated and potentially enhanced by AI. This submission is for an in vitro diagnostic reagent kit.
6. Standalone Performance Study
Yes, the studies described represent the standalone performance of the ATAC Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator when used on the ATAC 6000 Chemistry Analyzer. The reported linearity, precision, and detection limit are intrinsic performance characteristics of the assay and the analyzer system. The method comparison study also evaluates the algorithm (reagent kit + analyzer) performance against an established clinical method.
7. Type of Ground Truth Used
- Linearity: Based on "standard values" of linearity standards, which are known, precise concentrations.
- Precision: Based on the measured values of "commercially available control sera" at different concentration levels, where the 'true' value is often derived from extensive inter-laboratory studies or established reference values.
- Method Comparison: The "accepted clinical method" serves as the reference or 'gold standard' for comparison.
- Detection Limit: Derived from repetitive assay of a "diluted HDL-C control" with a known low concentration.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" in the context of an algorithm or machine learning model. This is an in vitro diagnostic (IVD) reagent kit, where the "training" is more akin to assay development and optimization rather than machine learning. The studies described are performance studies demonstrating the final product's characteristics.
9. How the Ground Truth for the Training Set was Established
As noted above, a distinct "training set" with ground truth in the conventional machine learning sense is not applicable here. The development and optimization of the reagent kit would involve formulating the reagent to achieve specific chemical reactions and analytical performance characteristics, which is guided by established chemical principles and perhaps empirical testing against known standards and samples, rather than a formal machine learning training process with a labeled dataset.
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K99 2029
élan diagnostics
Image /page/0/Picture/3 description: The image shows the logo for "élan". The logo features a stylized letter "e" formed by multiple parallel lines, giving it a dynamic and modern appearance. To the left of the "e", there are several short, horizontal lines that suggest movement or speed. Below the graphic is the word "élan" in a bold, sans-serif font.
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 Direct HDL Cholesterol Reagent Kit and the ATAC HDL-C Calibrator are intended for the quantitative determination of high density lipoprotein cholesterol in serum on the ATAC 6000 Chemistry Analyzer. 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.
The ATAC 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 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 Direct HDL Cholesterol Reagent Kit and the ATAC HDL-C Calibrator used on the ATAC 6000 Chemistry Analyzer are shown by the following studies.
The recovery of HDL cholesterol using the ATAC Direct HDL Cholesterol Reagent is linear from 2 mg/dL as shown by the recovery of linearity standards. Regression statistics, comparing standard recoveries, which range from 1.4 to 174 mg/dL, to standard values are shown below.
r2 = 0.999, (ATAC Recoveries) = 1.9 mg/dL + 1.074 x (Standard Value), sv.x = 1.62 mg/dL, di = 8
Precision, demonstrated by replicate assay of commercially available control sera, is shown below.
| Within Run | Total | |||||||
|---|---|---|---|---|---|---|---|---|
| Sample | n | mean | 1SD | %CV | n | mean | 1SD | %CV |
| Serum 1 | 22 | 35.4 | 0.84 | 2.4% | 40 | 32.7 | 2.47 | 7.6% |
| Serum 2 | 22 | 45.1 | 0.89 | 2.0% | 40 | 45.1 | 3.30 | 7.3% |
One hundred and thirty one serum specimens, collected from adult patients, were assayed for HDL cholesterol using the ATAC 6000 Chemistry Analyzer and another commercially available method. Results ranging from 25 to 107 mg/dl were compared by least squares linear regression and the following statistics were obtained.
y = - 2.4 mg/dL + 1.077x r = 0.962
y = ATAC 6000 results x = accepted clinical method
The detection limit claim of 2 mg/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 1.3 mg/dL and is below the claimed limit.
Wynn Stocking
Wynn Manager of Requiatory Affairs Elan Diagnostics
510(k) Notification, ATAC Direct HDL Cholesterol Kit 14 June, 1999, p 40
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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 12 1999
Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 231 N. Puente Street Brea, California 92821
K992029 Re:
Trade Name: ATAC Direct HDL Cholesterol Reagent and ATAC HDL-C Calibrator Kit Regulatory Class: II Product Code: LBR, JIS Dated: June 14, 1999 Received: June 16, 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 contact 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 Putman
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):
K 992039
Device Name:
ATAC Direct HDL Cholesterol Reagent and ATAC HDL-C Calibrator
Indications For Use:
The ATAC Direct HDL Cholesterol Reagent Kit and the ATAC HDL-C Calibrator are intended for the quantitative determination of high density lipoprotein cholesterol in serum on the ATAC 6000 Chemistry Analyzer. 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.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
Respectfully,
Wynn Stocking
Wynn Stocking
Regulatory Affairs Manager Elan Diagnostics
14 June, 1999
Hen Cooper
(Division Sign-Of
Division of Clinic
Respiratory Devices
510(k) Number K9922029
(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.