Beckman's Vigil Lipid Control is intended for use in monitoring the reliability of automated in vitro diagnostic assays of total cholesterol, HDL cholesterol (HDLc), triglycerides, apolipoprotein A-1 and apolipoprotein B in the clinical laboratory. The use of three or more levels of control allows the laboratorian to monitor change 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 Instruments, Inc. Each kit contains 4 X 4 mL bottles of a single level of control.

AI/ML Overview

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from predicate device)	Reported Device Performance (VIGIL™ Lipid Control)
Same intended use as predicate	Same intended use as predicate
Same value assignment process as predicate	Same value assignment process as predicate
Same storage temperature as predicate (-15 °C to -20°C)	Same formulation and storage at -15 °C to -20°C (Stress stability studies support 24 months, which is implied as being acceptable and comparable to the predicate).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state a "test set" in the traditional sense of evaluating diagnostic accuracy. Instead, the performance data provided is limited to stress stability studies.

Sample size: Not explicitly stated as a number of control samples. The studies involve measuring stability at various temperatures for different durations.
Data Provenance: Not specified, but likely internal Beckman Instruments testing given the context of a 510(k) submission. Retrospective or prospective is not explicitly mentioned, but stability studies are typically prospective, designed to evaluate product degradation over time.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a quality control material, not a diagnostic device that interprets clinical data or images. The "ground truth" for a quality control material is its assigned value(s) for the analytes it contains, which is established through a value assignment process. The document states this process is "Same as the predicate." Further details on how these values are established (e.g., use of reference methods, certified reference materials) are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As noted above, this is a quality control material, not a diagnostic device requiring interpretive adjudication.

5. 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 device is a quality control material and does not involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a quality control material for laboratory assays, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the VIGIL™ Lipid Controls refers to the assigned values of the individual analytes (total cholesterol, HDL cholesterol, triglycerides, apolipoprotein A-1, and apolipoprotein B) contained within the control material. The document explicitly states that the "Value Assignment" process is "Same as the predicate." While the specifics of this process are not detailed, for quality control materials, this typically involves:

Target Values: Established through analysis on highly accurate and precise reference methods or instruments, often linked to international reference materials.
Interlaboratory Consensus: Participation in interlaboratory proficiency testing programs where target values are determined by consensus of multiple expert laboratories using reference methods.

8. The sample size for the training set

The document does not refer to a "training set" in the context of machine learning. The studies described are performance studies for a quality control material, specifically shelf-life stability.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the machine learning sense for this device.

Summary

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K974452

Summary of Safety & Effectiveness Beckman VIGIL™ Lipid Controls

DEC 17 1997

1.0 Submitted By:

Richard T. Ross Staff Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4541

2.0 Date Submitted:

21 November 1997

3.0 Device Name(s):

3.1 Proprietary Names

VIGIL™ Lipid Control

3.2 Classification Name

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

4.0 Predicate Device(s):

WALL AND WARRETT STORES CONSTITUTION CONSULTION COLLECTION CONSULTER FEL PRODUCE COLLECT COLLECTION COLLECTION CONSULTION COLLECTION CONSULTED LINE COLLECT COLLECT COLLECT CO	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.	.CHARLE AR CHERE CONNUME LECCLEMENT COLLEGE COLLEGE COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION OF BEFORE OF BEFORE OF BEFORE OF BEFORE OF BEFORE OFNALE IN LIBER LINER LA. LANSARIA E LA REBILE S REE E S A T E F E SLA L L P P S P P P P P T T T L L T L . C . C . C . C	. THERE YES FENDER FELE BARBER FEE FREE FREE FREE F.

5.0 Description:

The VIGIL™ Lipid Controls are four level ready-to-use human serum-based liquid controls manufactured by Beckman Instruments, Inc. Each kit contains 4 X 4 mL bottles of a single level of control.

6.0 Intended Use:

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7.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.

SIMILARITIES to the PREDICATE

Reagent	Aspect/Characteristic	Comments
Vigil Lipid Control	Intended use	Same as the predicate
	Value Assignment	Same process as the predicate
	Storage Temperature	Same as predicate at-15 °C to -20°C

DIFFERENCES from the PREDICATE

Reagent	Aspect/Characteristic	Comments
Vigil Lipid Control	Formulation	Vigil Lipid: stabilized by storage at -15°C to -20°C
		Vigil PRx: stabilized with ethylene glycol and storage at -15°C to -20°C
	Levels of analyte	Vigil Lipid: 4 levels
		Vigil PRx: 3 levels
	Analytes	Vigil Lipid: Contains: cholesterol, HDL cholesterol, triglycerides, apolipoprotein A-1 and apolipoprotein B fortified to attain various levels.
		Vigil PRx. Contains: apolipoprotein A-1, apolipoprotein B and endogenous cholesterol, HDL cholesterol and triglycerides.

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence of the Vigil Lipid Controls to the Vigil PR. Stress stability studies of the Vigil Lipid Controls support the Beckman stability claim of 24 months.

Vigil Lipid Controls Shelf Life Stability Study Summary

Stress Temperature	Duration of Incubation	Beckman Stability Claim*
25°C	42 Days	24 months
32°C	45 Days	24 months
37°C	27 Days	24 months
41°C	20 Days	24 months

*Expiration dating placed on the package based on date of manufacture

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 17 100

Richard T. Ross Staff Requlatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Boulevard, M/S W-104 P.O. Box 8000 Brea, California 92822-8000

Re : K974452 VIGIL™ Lipid Controls Requlatory Class: I Product Code: د در ا Dated: November 21, 1997 Received: November 25, 1997

Dear Mr. Ross:

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 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 The general controls provisions of the Act 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 Requlations, 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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Page 2

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/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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974452

of page

510(k) Number (if known): Not yet assigned

VIGIL™ Lipid Control Device Name:

Indications for Use:

Beckman's Vigil Lipid Control is intended for use in monitoring the reliability of automated in vitro diagnostic assays of total cholesterol. HDL cholesterol (HDLc), triglycerides, apolipoprotein A-1 and apolipoprotein B in the clinical laboratory. The use of three or more levels of control allows the laboratorian to monitor change in calibration linearity along with analytical error and imprecision.

21 CFR 862.1660 Quality Control Material (assaved and unassayed)

(a) Identification. A quality control material (assaved and unassaved) 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 anse from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency studies 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.

(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

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K974452
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.