(22 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of AI/ML.
No
The device is described as a control for in vitro diagnostic assays, used for monitoring the reliability and calibration linearity of laboratory tests. It is not intended for treating or diagnosing diseases in patients.
No
Explanation: The device is a control material for monitoring the reliability of in vitro diagnostic assays, not a diagnostic device itself. It helps evaluate the performance of diagnostic tests rather than directly diagnosing conditions.
No
The device description explicitly states that the device is "four level ready-to-use human serum-based liquid controls," indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the control is "intended for use in monitoring the reliability of automated in vitro diagnostic assays". This directly links the device to the process of performing in vitro diagnostics.
- Device Description: The description mentions it's a "human serum-based liquid control". Controls are a common component used in IVD testing to ensure the accuracy and reliability of the assays.
- Care Setting: The "Intended User / Care Setting" is the "clinical laboratory", which is the typical environment where IVD testing is performed.
The purpose of this device is to monitor the performance of other IVD assays, making it an essential part of the IVD testing process itself.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JJX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 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.
0
1
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 OF
NALE IN LIBER LINER LA
. LANSARIA E LA REBILE S REE E S A T E F E S
LA 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:
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.
1
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.
2
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
4
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