(15 days)
Not Found
No
The document describes a liquid control material for laboratory protein tests and contains no mention of AI or ML.
No
This device is a control used for monitoring the performance of specific protein test systems in a clinical laboratory. It is not used for treating or diagnosing patients.
No
This device is a control material used for monitoring the performance of specific protein test systems, not for diagnosing a condition in a patient.
No
The device description clearly states it is a "ready-to-use human serum-based liquid control," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monitoring the reliability and overall performance of specific protein tests systems in the clinical laboratory." This is a classic function of an IVD - to ensure the accuracy and reliability of other diagnostic tests performed on biological samples.
- Device Description: It's a "human serum-based liquid control." IVDs are designed to be used with biological samples (in this case, the control itself is derived from human serum) to provide information about a patient's health.
- Care Setting: It's intended for use in a "clinical laboratory," which is the typical environment where IVD tests are performed.
The purpose of this control is to verify that the protein tests being run in the lab are working correctly, which directly impacts the diagnostic information derived from patient samples. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Beckman Coulter's Protein Control is intended for use in monitoring the reliability and overall performance of specific protein tests systems in the clinical laboratory. The use of three levels of control allows the laboratorian to monitor change in calibration linearity along with analytical error and imprecision.
Product codes
JJY
Device Description
The Vigil™ Protein Controls are three level ready-to-use human serum-based liquid controls manufactured by Beckman Coulter, Inc. Each kit contains 4 X 5 mL bottles of a sinale level of control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
9 1998 JUL
Beckman Coulter, Inc., Section 510(k) Notification VIGIL Protein Controls Summary of Safety & Effectiveness
Summary of Safety & Effectiveness Beckman Coulter Vigil™ Protein Controls
1.0 Submitted By:
Richard T. Ross Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Blvd., W-104 Brea. California 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4123
2.0 Date Submitted:
22 June 1998
3.0 Device Name(s):
3.1 Proprietary Names
Vigil™ Protein Control
3.2 Classification Name
Quality Control Material (assayed and unassayed) (21 CFR § 862.1660)
4.0 Predicate Device(s):
| BECKMAN COULTER
Reagent | Predicate | Predicate Company | Docket
Number |
|----------------------------|------------------------|------------------------------|------------------|
| Vigil™ Protein Controls | Vigil PRₓ™
Controls | Beckman Instruments,
Inc. | K936184 |
5.0 Description:
The Vigil™ Protein Controls are three level ready-to-use human serum-based liquid controls manufactured by Beckman Coulter, Inc. Each kit contains 4 X 5 mL bottles of a sinale level of control.
6.0 Intended Use:
Beckman Coulter's Protein Control is intended for use in monitoring the reliability and overall performance of specific protein tests systems in the clinical laboratory. The use of three levels of control allows the laboratorian to monitor change in calibration linearity along with analytical error and imprecision.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
0 1338 JUL
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Richard T. Ross Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kramer Boulevard, M/S W-104 P.O. Box 8000 Brea, California 92822-8000
K982224 Re : Vigil™ Protein Controls Regulatory Class: I Product Code: JJY Dated: June 22, 1998 Received: June 24, 1998
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 requlations 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 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 regulations.
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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" (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 "dsmo@fdadr.cdrh.fda.gov".
Sincerely yours,
Steven Autman
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): Not yet assigned
Vigil™ Protein Control Device Name:
Indications for Use:
Beckman Coulter's Protein Control is intended for use in monitoring the reliability and overall performance of specific protein tests systems in the clinical laboratory. The use of three 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 (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 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 (OBE)
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K98 224