(49 days)
ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of antibodies to Hepatitis B e Antigen (HBeAg). This control is not intended as a substitute for controls provided with test kits.
ACCURUN 119 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.
human blood based single analyte run control
The provided text is related to a 510(k) premarket notification for a medical device called "ACCURUN™ 119 Anti-Hepatitis B e Antigen (Anti-HBE Positive) Control." This document is an FDA clearance letter from 1997.
Crucially, this document does not contain information about the acceptance criteria, device performance study details, or ground truth establishment that would be required to fill out the table and answer the supplementary questions.
The letter primarily:
- Acknowledges the review of the 510(k) submission.
- Determines substantial equivalence to a predicate device.
- Grants permission to market the device subject to general controls.
- Provides information about CLIA-88, labeling regulations, and other responsibilities.
- Includes the intended use statement for the device.
Therefore, I cannot provide the requested information based on the given input. The information about the study that proves the device meets acceptance criteria, the specific performance metrics, sample sizes, expert qualifications, and ground truth methodologies are typically found in the 510(k) summary or the full 510(k) submission, not in the FDA clearance letter itself.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
AUG - 7 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Patricia E. Garrett, Ph.D. Senior Vice President Strategic Programs and Requlatory Affairs Boston Biomedica, Inc. 375 West Street West Bridgewater, Massachusetts 02379
Re: K972307/S1 Trade Name: ACCURUN™ 119 Anti-Hepatitis B e Antigen (Anti-HBE Positive) Regulatory Class: I Product Code: JJY Dated: July 15, 1997 Received: July 16, 1997
Dear Dr. Garrett:
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, qood 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 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 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 requlation 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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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) Additionally, for questions on the promotion and 594-4588. 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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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Boston Biomedica, Inc. 510(k) Notification ACCURUN 119 Anti-HBe Positive Control
Page of
510(k) Number (if known): J 992 307
Device Name: ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control
Indications For Use:
ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of antibodies to Hepatitis B e Antigen (HBeAg). This control is not intended as a substitute for controls provided with test kits.
ACCURUN 119 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Kayme Huey la Laken Penkos 1/28
oncurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Clinical Laboratory Devices 130 510(k) Number.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use____________
(Optional Format 1-2-96)
§ 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.