(15 days)
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No
The document describes liquid controls for monitoring the performance of drug test systems and does not mention any AI or ML components.
No.
Explanation: The device is described as a "control" used for monitoring the performance of other drug test systems, not for directly treating a patient or having a therapeutic effect.
No
The device is described as controls for monitoring the reliability and performance of existing drug test systems, not for diagnosing patients.
No
The device description explicitly states it is a "human serum-based liquid control" and comes in "bottles," indicating it is a physical reagent, not software.
Based on the provided information, the Beckman Vigil Therapeutic Drug Monitoring (TDM) Controls are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use explicitly states they are "designed for monitoring the reliability and overall performance of Beckman Therapeutic drug test systems in the clinical laboratory." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, they are used to monitor the performance of tests that analyze human specimens.
- Device Description: The description states they are "human serum-based liquid controls." This indicates they are used in conjunction with tests performed on human biological samples.
- Intended User / Care Setting: The intended user is a "clinical laboratory / laboratorian," which is the typical setting for performing in vitro diagnostic tests.
While they are not directly used to diagnose a patient's condition, they are essential components in ensuring the accuracy and reliability of the diagnostic tests that are used for diagnosis and monitoring. They fall under the category of quality control materials, which are considered IVDs by regulatory bodies like the FDA.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DIF
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stress stability studies of the Vigil TDM Controls support the Beckman stability claim of 24 months.
Stress Temperature: 25°C, Duration of Incubation: 35 Days, Beckman Stability Claim*: 24 months
Stress Temperature: 32°C, Duration of Incubation: 30 Days, Beckman Stability Claim*: 24 months
Stress Temperature: 37°C, Duration of Incubation: 18 Days, Beckman Stability Claim*: 24 months
Stress Temperature: 41°C, Duration of Incubation: 11 Days, Beckman Stability Claim*: 24 months
*Expiration dating placed on the package based on date of manufacture
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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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1
5.0 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.
6.0 intended 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.
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 plasma | ||
| defibrinated and stabilized with ethylene | ||
| glycol | ||
| 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. |
2
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.
3
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.
4
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
5
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 Use
Optional Format 1-2-96 |
| ------------------------------------------ | ---- | ------------------------------------------------ |
|---|