(15 days)
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.
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.
The provided document is a 510(k) premarket notification for a medical device called "Vigil™ Protein Controls". This device is a quality control material intended for use in monitoring the reliability and performance of specific protein test systems in a clinical laboratory.
The document does not contain information regarding acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone). It is a regulatory submission for a quality control material, not a diagnostic or therapeutic device requiring such performance studies.
Therefore, I cannot provide the requested information based on the input document.
Summary of what is present in the document:
- Device Name: Vigil™ Protein Control
- Intended Use: Monitoring the reliability and overall performance of specific protein test systems in the clinical laboratory.
- Classification: Class I, Product Code JJY (Quality Control Material, assayed and unassayed, per 21 CFR § 862.1660)
- Predicate Device: Vigil PRₓ™ Controls (K936184)
- Manufacturer: Beckman Coulter, Inc.
- Regulatory Decision: Substantially Equivalent (K982224)
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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 COULTERReagent | Predicate | Predicate Company | DocketNumber |
|---|---|---|---|
| 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.
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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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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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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
§ 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.