(98 days)
Boston Biomedica intends to manufacture and market ACCURUN 121 HAV IgM Positive Control, which is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Hepatitis A Virus (HAV). This control is not intended as a substitute for controls provided with test kits.
This product will be made available to clinical laboratory professionals in blood banks, public health laboratories and clinical laboratories for use with in virro diagnostic tests for the detection of IgM antibodies to HAV in human serum and plasma.
human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Hepatitis A Virus (HAV).
This document is a 510(k) clearance letter from the FDA for a medical device called ACCURUN™ 121 HAV IgM Positive Control. It does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance. The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document describes the intended use of the device: "a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Hepatitis A Virus (HAV)." It also mentions that the product will be available to clinical laboratory professionals for use with in vitro diagnostic tests. This indicates the device is a control material for diagnostic tests, not a diagnostic test itself or an AI-powered device.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Patricia E. Garrett, Ph.D. Senior Vice President Strategic Programs and Regulatory Affairs Boston Biomedica, Inc. 375 West Street West Bridgewater, Massachusetts 02379
AUG 1 2 1997
Re : K971657/S1 Trade Name: ACCURUN™ 121 HAV IgM Positive Control Requlatory Class: I Product Code: JJY Dated: July 7, 1997 Received: July 9, 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, 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 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 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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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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 121 HAV IgM Positive Control
Page I of I
| 510(k) Number (if known): | K971657 |
|---|---|
| Device Name: | ACCURUN 121 HAV IgM |
Indications For Use:
Boston Biomedica intends to manufacture and market ACCURUN 121 HAV IgM Positive Control, which is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Hepatitis A Virus (HAV). This control is not intended as a substitute for controls provided with test kits.
This product will be made available to clinical laboratory professionals in blood banks, public health laboratories and clinical laboratories for use with in virro diagnostic tests for the detection of IgM antibodies to HAV in human serum and plasma.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
A. Ingram, Linda for Arthur Purka 11/28/92
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Clinical Laboratory Devices 97165 510(k) Number .
Prescription Use
(Per 21 CFR 80i.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.