(50 days)
The ATAC Direct LDL Reagent Kit, the ATAC Direct LDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for the quantitative determination of LDL-cholesterol in serum and plasma. LDL-cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
The ATAC Direct LDL Reagent determines LDL-cholesterol through a two step reaction, which specifically consumes non-LDL cholesterol in a series of reactions without producing color. In the second reaction step, the chromogen is added, and a second detergent solubilizes the LDL-cholesterol, allowing it to react with cholesterol oxidase, cholesterol esterase and peroxidase in the reagent to produce a color that is proportional to the amount of LDL-cholesterol in the sample.
Here's a breakdown of the acceptance criteria and the study details for the ATAC Direct LDL Reagent Kit, ATAC Direct LDL Calibrator, and ATAC 8000 Random Access Chemistry System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (ATAC System) |
|---|---|
| Linearity Range | 5 to 700 mg/dL |
| Linearity (Regression Equation - forced through origin) | (ATAC Recoveries) = 0 mg/dL + 1.023 x (Standard Factors) |
| Precision (Within Run) - Low LDL (Serum 1, ~93 mg/dL) | 1SD = 1.4 mg/dL (1.5% CV) |
| Precision (Within Run) - Medium LDL (Serum 2, ~184 mg/dL) | 1SD = 3.3 mg/dL (1.8% CV) |
| Precision (Within Run) - High LDL (Serum 3, ~555 mg/dL) | 1SD = 11.9 mg/dL (2.2% CV) |
| Precision (Total) - Low LDL (Serum 1, ~93 mg/dL) | 1SD = 2.7 mg/dL (2.9% CV) |
| Precision (Total) - Medium LDL (Serum 2, ~184 mg/dL) | 1SD = 4.9 mg/dL (2.7% CV) |
| Precision (Total) - High LDL (Serum 3, ~555 mg/dL) | 1SD = 19.2 mg/dL (3.5% CV) |
| Correlation with Competitive Reagent (Regression Equation) | ATAC 8000 = -1.7 mg/dL + 1.078 x Competitive Reagent |
| Correlation with Competitive Reagent (Correlation Coefficient) | r = 0.996 |
| Correlation with Competitive Reagent (Range) | 19 - 265 mg/dL |
| Accuracy (Correlation with Beta-Quantification Reference Method - Regression Equation) | ATAC 8000 = -4.2 mg/dL + 1.035 x reference method |
| Accuracy (Correlation with Beta-Quantification Reference Method - Correlation Coefficient) | r = 0.986 |
| Accuracy (Correlation with Beta-Quantification Reference Method - Range) | 59 - 178 mg/dL |
| Detection Limit Claim | 5 mg/dL |
| Observed Detection Limit | 0.73 mg/dL (calculated as 2 SD of 30 replicate within run precision) |
| On-board Reagent Stability | 14 days (total imprecision < 3%) |
| Calibration Stability | 14 days (total imprecision < 3%) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Linearity Study: n = 35 (number of standard factors, implicitly indicating the number of samples used to establish linearity)
- Precision Study:
- Serum 1: n = 60
- Serum 2: n = 60
- Serum 3: n = 59
- Comparison to Competitive Reagent: n = 159 (mixed serum and plasma specimens from adult patients)
- Accuracy (Comparison to Beta-Quantification Reference Method): n = 42 (serum and plasma specimens from 22 adults)
- Detection Limit Study: 30 replicates of a diluted serum pool.
Data Provenance: The text states, "Mixed serum and plasma specimens, collected from adult patients," and "42 serum and plasma specimens, collected from 22 adults." This indicates the data is from human patients. While the specific country of origin is not explicitly stated, the submission is to the US FDA, implying testing relevant to that regulatory body, likely involving US-based studies. The studies are prospective in nature, as they involve performing assays to determine the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device is an in vitro diagnostic for measuring a chemical analyte (LDL-cholesterol). The "ground truth" is established by standard laboratory reference methods or highly-regarded comparative methods, not by expert interpretation of images or other subjective assessments.
- For "Accuracy" studies: The ground truth was established by the beta-quantification reference method.
- For "Comparison" studies: The ground truth was established by a "commercially available method" (another LDL-cholesterol assay).
Therefore, there were no human "experts" in the sense of clinicians or radiologists establishing ground truth. The "experts" are the established and validated laboratory methodologies.
4. Adjudication Method for the Test Set
Not applicable for this type of in vitro diagnostic device study. Adjudication methods (like 2+1, 3+1) are typically used for studies where multiple human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to form a ground truth. Here, the ground truth is determined by objective chemical or reference methods.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not relevant for this type of in vitro diagnostic device. This device measures an analyte; it's not an imaging or diagnostic tool where human readers interpret outputs.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes, the studies directly assess the "standalone" performance of the ATAC Direct LDL Reagent Kit and the ATAC Direct LDL Calibrator used on the ATAC 8000 Random Access Chemistry System. The reported performance metrics (linearity, precision, correlation, accuracy, detection limit, stability) are all measurements of the device's inherent capability, without human intervention in the analytical measurement process itself. The "human-in-the-loop" would be the laboratory personnel operating the system and interpreting the quantitative numerical results, but the performance data presented here are for the device alone.
7. Type of Ground Truth Used
The ground truth used in the studies includes:
- Reference Method: Beta-quantification method (for accuracy assessment). This is a highly accurate and established method for measuring LDL-C.
- Comparative Commercial Method: Another commercially available LDL-cholesterol assay (for method comparison).
- Standard Factors: Pre-defined concentrations of LDL-cholesterol (for linearity assessment).
- Commercially Available Control Serum / Serum Pool: Materials with known or expected LDL-C values (for precision assessment).
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a chemical reagent and an automated chemistry analyzer, not an AI/ML algorithm that requires training data in the typical sense. It relies on chemical reactions and photometric detection calibrated against known standards.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML sense for this type of device, this question is not applicable. The device's operational parameters and calibration are established using defined standards and controls, as outlined in the linearity and stability studies, which serve a similar function to "training" in ensuring the device performs correctly.
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élan diagnostics
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020575
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 LDL Reagent Kit, the ATAC Direct LDL Calibrator and the ATAC 8000 Random Access Chemistry THE ATAC DICCLEDE Reagent Not the quantitative determination of LDL-cholesterol in serum and planna. System ate intended for the diagnosis and treatment of lipid disorders (such as diabetes mellius), atherosclerosis, LDL-choices liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
The ATAC Direct LDL Reagent determines LDL-cholesterol through a two step reaction, which depecial The ATAC Direct LDL Neagult determines in checked are consumed in a series of reactions without producing color. In the second reaction step, the chromogen is added, and a second detergent solubilizes the LDLproducing color. In ano socond receit with cholesterol oxidase, cholesterol esterase and peroxidase in the reagent to produce a color that is proportional to the amount of LDL-cholesterol in the sample.
The ATAC Direct LDL Reagent Kit, calibrated with the ATAC Direct LDL Calibrator, is substantially equivalent of the collibrary The ATAC Ditch LDL Reagent Tit, callerined with 1.80-4598-00, calibrated with N-geneous LDL Cholesterol Calibrator, N-gencous DDI Choicerer reagent ready marketed by Genzyme Corporation of Cambridge, MA.
The effectiveness of ATAC Direct LDL Reagent Kit and the ATAC Direct LDL Calibrator used on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
The recovery of LDL-cholesterol using the ATAC Direct LDL Reagent is linear from 5 to 700 mg/dL as shown by the I ne recovery of LDL-notestere used insable range. Linear regression statistics, with the regression line forced through the origin, compare standard recoveries to standard factors.
(ATAC Recoveries) = 0 mg/dL + 1.023 x (Standard Factors), n = 35
Precision is demonstrated by the replicate assay of commercially available control serum and a serum pool. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
| Precision of LDL-Cholesterol Recoveries in mg/dL | ||||||
|---|---|---|---|---|---|---|
| Sample | n | mean | Within Run | Total | ||
| 1SD | %CV | 1SD | %CV | |||
| Serum 1 | 60 | 93 | 1.4 | 1.5% | 2.7 | 2.9% |
| Serum 2 | 60 | 184 | 3.3 | 1.8% | 4.9 | 2.7% |
| Serum 3 | 59 | 555 | 11.9 | 2.2% | 19.2 | 3.5% |
Mixed serum and plasma specimens, collected from adult patients, were assayed for LDL cholesterol using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by least squares linear regression and the following statistics were obtained.
Serum/Plasma Comparison ATAC 8000 = - 1.7 mg/dL + 1.078 x Competitive Reagent range = 19 - 265 mg/dL r = 0.996 n = 159
510(k) Notification, ATAC Direct LDL Reagent Kit, 20 Sept., 2002, p 57
Elan Diagnostics 1075 W. Lambert Road · Brea California · 92821 Phone: 714.672.3553 · Fax: 714.672.3554
Elan Diagnostics is a division of Elan Pharmaceuticals
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To verify accuracy, 42 serum and plasma specimens, collected from 22 adults were assayed for LDL cholesterol using the ATAC 8000 Random Access Chemistry System and the beta-quantification reference method. Results were compared by least squares linear regression and the following statistics were obtained.
Serum/Plasma Comparison ATAC 8000 = - 4.2 mg/dL + 1.035 x reference method r = 0.986 n = 42 range = 59 - 178 mg/dL
The detection limit claim of 5 mg/dL is documented through the repetitive assay of a diluted serum pool. The observed detection limit, calculated as two standard deviations of a 30 replicate within run precision study, is 0.73 mg/dL and is below the claimed limit.
The 14 day on board reagent stability and 14 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of LDL-cholesterol recoveries over the test periods are less than 3%.
Wyman Stocking
Wynn Stocking Manager of Regulatory Affairs Elan Diagnostics
510(k) Notification, ATAC Direct LDL Reagent Kit, 20 Sept., 2002, p 57
Elan Diagnostics 1075 W. Lambert Road · Brea California 92821 Phone: 714.672.3553 · Fax: 714.672.3554
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
PR 1 2 2002
Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road, Building D Brea, California 92821
Re: K020575
Trade/Device Name: ATAC Direct LDL Reagent and ATAC Direct LDL Calibrator Regulation Number and Name: 21 CFR § 862.1475-Low density lipoprotein test system Regulation Number and Name: 21 CFR § 862.1150-Calibrator, secondary Product Code: MRR Regulatory Class: I Regulatory Class: II Product Code: JIT Dated: February 20, 2002 Received: February 21, 2002
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket I this lotter will and hype and al 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 If you dosire opening ad 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, (Jorg Sy Potter of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on 90 m 100 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 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):
02-0575
ATAC Direct LDL Reagent and ATAC Direct LDL Calibrator
Device Name:
Indications For Use:
The ATAC Direct LDL Reagent Kit, the ATAC Direct LDL Calibrator and the ATAC 8000 Random Access Chemistry THE ATAC DIFOLLEDE Notes and INT, the Quantitative determination of LDL-cholesterol in serum and plasma. LDL-System are included to the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atheroscherosis, and various liver and renal diseases, and for the assessment of the risk of developing 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
20 February, 2002
(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.