K Number
K972307
Device Name
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
Date Cleared
1997-08-07

(49 days)

Product Code
Regulation Number
862.1660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
human blood based single analyte run control
More Information

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No
The summary describes a human blood-based control for laboratory testing, with no mention of AI or ML technologies.

No.
Explanation: The device is a control for laboratory tests, not a device used to treat a disease or condition.

No
Explanation: This device is a control used to estimate laboratory testing precision and detect errors in testing procedures, not to diagnose a condition in a patient.

No

The device is described as a "human blood based single analyte run 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 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 describes a product used in vitro (outside the body) to evaluate the performance of a diagnostic test.
  • Function: It's used to "estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures." This is a core function of an IVD control.
  • Device Description: It's described as a "human blood based single analyte run control," which is a typical description for an IVD control.

While it's a control and not the primary diagnostic test itself, controls used in conjunction with diagnostic tests are considered IVDs because they are essential for ensuring the accuracy and reliability of the diagnostic results.

N/A

Intended Use / 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.

Product codes

JJY

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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Key Metrics

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 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.

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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)