Vigil Lipid Control stabilized liquid-control serums are intended for monitoring the reliability of manual and automated in vitro diagnostic assays of lipid analytes. The values for this control have been established using Beckman Coulter Reagents on Beckman Coulter Clinical Analyzers, and are specific for those systems. The use of three or more levels of control enables the laboratorian to monitor changes in calibration linearity along with analytical error and imprecision.

Device Description

The Vigil Lipid Controls are four-level, ready-to-use human serum-based liquid controls manufactured by Beckman Coulter, Inc. Each kit contains 4 X 4 mL bottles of a single level of control. Vigil Lipid Controls are made from stabilized human serum and are designed to monitor the reliability of manual and automated in vitro diagnostic assays of lipid analytes in the clinical laboratory. Vigil Lipid Control serum is derived from human plasma that has been defibrinated and then stabilized by freezing at temperature between -15°C and -20°C.

AI/ML Overview

The provided document, a 510(k) summary for the "Vigil™ Lipid Control," primarily focuses on regulatory approval and substantial equivalence to a predicate device. It lacks detailed information about specific acceptance criteria, study methodologies, and performance data typically found in a comprehensive clinical or performance study report. Therefore, I cannot fully answer all aspects of your request based on the provided text.

Here is an analysis of what information can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

The document states: "Performance data from validation testing supports equivalency." However, it does not provide a table of specific acceptance criteria (e.g., precision limits, accuracy targets) nor the reported device performance values against those criteria.

Missing Information:

The document does not contain the following information:

Sample size used for the test set and the data provenance: There is no mention of a specific test set, its size, or the country of origin of the data, nor is it stated whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or their qualifications for establishing ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Since no test set or expert ground truth establishment is described, no adjudication method is detailed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This type of study is not mentioned as this is a quality control material, not typically an imaging or diagnostic device requiring MRMC studies.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable as the device is a quality control material, not an algorithm.
The type of ground truth used: There is no explicit mention of ground truth as the document focuses on the control's performance with specific analyzers and reagents. For a quality control material, "ground truth" would typically refer to the accurately assigned values for the analytes within the control, established through a robust reference method or certified reference materials. The document states, "The values for this control have been established using Beckman Coulter Reagents on Beckman Coulter Clinical Analyzers, and are specific for those systems," implying that the "truth" for the control's performance is tied to its expected behavior on the specified systems.
The sample size for the training set: This is not applicable as the device is a quality control material, not an AI/algorithm-based device that requires a training set.
How the ground truth for the training set was established: This is not applicable.

Explanation for Missing Information:

The "Vigil™ Lipid Control" is a quality control material for in vitro diagnostic assays. Its regulatory submission (510(k)) primarily focuses on demonstrating that it is "substantially equivalent" to a legally marketed predicate device, especially after modifications (rewording of intended use, adding value assignments for new assays). For this type of device, the "study that proves the device meets the acceptance criteria" would typically involve:

Value Assignment Studies: Establishing the target ranges for various lipid analytes within the control material when run on specific Beckman Coulter analyzers with specific reagents.
Stability Studies: Demonstrating that the control material maintains its assigned values and integrity over its shelf life and during use.
Homogeneity Studies: Ensuring that the control material is uniform throughout the batch.
Performance on Target Systems: Running the control on the intended analyzers to verify it performs within acceptable ranges (precision, bias) and can detect significant shifts in assay performance.

The provided 510(k) summary states "Performance data from validation testing supports equivalency," meaning these types of tests were likely performed to demonstrate that the modified Vigil Lipid Control performs similarly to the predicate Vigil Lipid Control and can fulfill its intended purpose of monitoring assay reliability. However, the details of these tests (specific acceptance criteria, results, sample sizes, etc.) are not included in this high-level summary. They would typically be found in the full 510(k) submission not publicly disclosed in this format.

Summary

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2002 MAR 1

510(k) Summary Vigil™ Lipid Control

020521

1.0 Submitted By

Gail Lefebvre Requlatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, CA 92822-8000 Telephone: (714) 993-8503 FAX: (714) 961-4123

2.0 Date Submitted

February 14, 2002

3.0 Device Name(s)

3.1 Proprietary Names

Vigil™ Lipid Control

3.2 Classification Names

Quality Control Material (assayed and unassayed) (21 CFR § 862.1660)

4.0 Legally Marketed Device

The Beckman Coulter Vigil Lipid Control claims substantial equivalence to the Beckman Coulter Vigil Lipid Control currently in commercial distribution, FDA 510(k) Number K974452.

5.0 Device Description

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6.0 Intended Use

7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)

The Intended Use statement for the Vigil Lipid Control has been reworded to a generic statement for lipid analytes. Value assignment for Beckman Coulter's SYNCHRON Systems LDL Cholesterol (LDLD) and Direct HDL (HDLD) assays have been added to the product insert.

8.0 Summary of Performance Data

Performance data from validation testing supports equivalency.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR & 807.92.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 2002

Ms. Gail Lefebvre Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. M/S W-104 Box 8000 Brea, CA 92822-8000

Re: K020521

Trade/Device Name: Vigil™ Lipid Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: February 14, 2002 Received: February 19, 2002

Dear Ms. Lefebvre:

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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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page 1 of 1

510(k) Number (if known): To be assigned KO2OS2

Vigil™ Lipid Control Device Name:

Indications for Use:

Can
(Division Sign-Off)
Division of Clinical L
510(k) Number K020521

(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)

Over-the-Counter Use Optional Format 1-2-96

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.