(71 days)
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No
The document describes a laboratory control material for Hepatitis B testing and contains no mention of AI or ML.
No
The device is described as an independent run control for laboratory tests, intended to estimate testing precision and detect errors in procedures, not to treat or diagnose a disease.
No
This device is a control for tests that detect Hepatitis B e Antigen (HBeAg). Its intended use is to "estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures," not to diagnose a patient.
No
The device description explicitly states it is 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 Hepatitis B e Antigen (HBeAg)." This indicates it's used in vitro (outside the body) to evaluate the performance of diagnostic tests.
- Device Description: The description confirms it's "a human blood based single analyte run control," reinforcing its use with biological samples.
- Intended User / Care Setting: It's intended for "Laboratory testing procedures," which is a typical setting for IVD use.
The purpose of this control is to assess the accuracy and reliability of diagnostic tests for HBeAg, which is a key function of an IVD control.
N/A
Intended Use / Indications for Use
ACCURUN 117 HBeAg 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 Hepatitis B e Antigen (HBeAg). This control is not intended as a substitute for controls provided with test kits.
ACCURUN 117 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 (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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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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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: K972048/S1 Trade Name: ACCURUN™ 117 HBeAg Positive Control Requlatory 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, Druq, 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 Reqister. 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 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 117 HBeAg Positive Control
Page _ of _
510(k) Number (if known):
Device Name:_ ACCURUN 117 HBeAg Positive Control
Indications For Use:
ACCURUN 117 HBeAg 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 Hepatitis B e Antigen (HBeAg). This control is not intended as a substitute for controls provided with test kits.
ACCURUN 117 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)
Quinne Shively, ga. Culeon Pinka 1/25/92
ORH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K972048 |
|---|---|
| --------------- | --------- |
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)