The Beckman Vigil Therapeutic Drug Monitoring (TDM) Controls are designed for monitoring the reliability and overall performance of Beckman Therapeutic drug test systems in the clinical laboratory. The use of three levels of control allows the laboratorian to monitor change in calibration along with analytical error and imprecision.

Device Description

The VIGIL™ TDM Controls are tri-level ready-to-use human serum-based liquid controls manufactured by Beckman Instruments, Inc. Each kit contains 3 X 3 mL bottles of a specific level of control. The levels are identified as Vigil TDM Control Level 1, Vigil TDM Control Level 2, and Vigil TDM Control Level 3. The products require no preparation prior to use and must be stored at +2° C to +8°C when not in use.

AI/ML Overview

The provided text describes the Beckman VIGIL™ TDM Controls, which are clinical toxicology control materials. The study presented focuses on the stability of these controls rather than a functional performance study with a diagnostic algorithm. Therefore, many of the requested categories in your prompt are not applicable.

Here's the information that can be extracted from the provided text, adapted to the context of a control material's stability study:

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

Acceptance Criteria (Implied)	Reported Device Performance (Stability)
Device stability must support a 24-month shelf life.	Stress stability studies at various temperatures (25°C, 32°C, 37°C, 41°C) demonstrate stability over various durations, supporting the 24-month stability claim.

2. Sample size used for the test set and the data provenance

The document does not specify a "sample size" in terms of individual units of control material tested for stability. It refers to "stress stability studies" and "Vigil TDM Controls Stability Study." The provenance of the data is Beckman Instruments, Inc., and the study appears to be retrospective as part of the premarket notification.

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

Not applicable. This is a stability study for a control material, not a diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. There is no expert review or adjudication process described for the stability study. Stability is determined by laboratory testing against established specifications.

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 study is for a control material, not a diagnostic device, 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 study is for a control material, not an algorithm.

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

The "ground truth" for this study is the inherent stability of the control material, determined by quantitative analytical methods and comparison to pre-defined acceptance limits for analytes within the controls, measured over time and under stress conditions. The document states, "Stress stability studies of the Vigil TDM Controls support the Beckman stability claim of 24 months." This implies that the control material maintained its specified characteristics within acceptable limits after being subjected to the stress conditions.

8. The sample size for the training set

Not applicable. This is a stability study for a control material, not a machine learning model requiring a training set.

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

Not applicable. This is a stability study for a control material, not a machine learning model.

Summary

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AUG 1 3 1997

Summary of Safety & Effectiveness Beckman VIGIL™ TDM Controls

1.0 Submitted By:

Lucinda Stockert Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4457

2.0 Date Submitted:

28 July 1997

3.0 Device Name(s):

3.1 Proprietary Names

VIGIL™ TDM Control

3.2 Classification Name

Clinical Toxicology Control Material (21 CFR § 862.3280)

4.0 Predicate Device(s):

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5.0 Description:

6.0 intended Use:

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 TDM Control	Intended use	Same as the predicate
Vigil TDM Control	Value Assignment	Same process as the predicate

DIFFERENCES from the PREDICATE

Reagent	Aspect/Characteristic	Comments
Vigil TDM Control	Formulation	Vigil TDM: delipidized human serum
		Vigil PRx: fresh frozen human plasmadefibrinated and stabilized with ethyleneglycol
	Kit Configuration	Vigil TDM: 3 X 3 mL bottles
		Vigil PRx: 4 X 5 mL bottles
	Storage Temperature	Vigil TDM: +2°C to +8°C
		Vigil PRx: -15°C to -20°C
	Analytes	Vigil TDM: Contains Digoxin.
		Vigil PRx Does not contain Digoxin.

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Summary of Performance Data: 8.0

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

Viqil TDM Controls Stability Study Summary

Stress Temperature	Duration of Incubation	Beckman Stability Claim*
25°C	35 Days	24 months
32°C	30 Days	24 months
37°C	18 Days	24 months
41°C	11 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

Ms. Lucina Stockert Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd. Box 8000 92822-8000 Brea, CA

K972819 Re : VIGIL™ TDM Controls Requlatory Class: I DIF Product Code: Dated: July 28, 1997 Received: July 29, 1997

Dear Ms. Stockert:

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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

AUG 1 3 1997

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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 GMF regulation may result in regulatory In addition, FDA may publish further announcements action. 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 Requlations.

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Paqe 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 marrees 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 enc office of compriand as (or compranding 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 Sitman

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 of

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

VIGIL™ TDM Control Device Name:

Indications for Use:

The Beckman Vigil Therapeutic Drug Monitoring (TDM) Controls are designed for monitoring the reliability and overall performance of Beckman Therapeutic Drug test systems in the clinical laboratory. The use of three levels of control allows the laboratorian to monitor change in calibration along with analytical error and imprecision. 4:4

21 CFR 862.3280 Clinical Toxicology Control Material

(a) loentification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

(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)

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

Prescription Use(per 21 CFR 801.109)	OR	Over-the-Counter UseOptional Format 1-2-96
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Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(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 the limitations in § 862.9.