(62 days)
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K/DEN number and list them here in a comma separated list exactly as they appear in the text:
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No
The document describes a laboratory control solution for monitoring the precision of BNP assays, with no mention of AI or ML technology.
No
The device is a laboratory control for monitoring the precision of testing procedures, not for treating a patient's condition.
No
This device is a reference control intended for monitoring the precision and detecting systematic analytical deviations of laboratory testing procedures, not for diagnosing medical conditions in patients.
No
The device description explicitly states it is a "human plasma based solution," 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 explicitly states it's for "monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for both BNP-32 and NT-proBNP assays." This is a classic function of a control material used in laboratory testing.
- Device Description: It's described as "assayed bi-level reference control consisting of human plasma based solutions." This further confirms its role as a control used in laboratory settings.
- Intended User / Care Setting: It specifies "laboratory testing procedures," indicating it's used in a laboratory environment.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific device is a control and not directly used for diagnosis, it is an essential component of the overall in vitro diagnostic process, ensuring the accuracy and reliability of the diagnostic assays (BNP-32 and NT-proBNP assays) that are used for diagnosis. Therefore, it falls under the umbrella of IVDs.
N/A
Intended Use / Indications for Use
Audit™ MicroFD™ BNP Control is an assayed bi-level reference control consisting of human plasma based solutions. It is intended to simulate human patient plasma samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for both BNP-32 and NT-proBNP assays.
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and healing. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The logo is black and white and has a simple, clean design.
SEP - 9 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Alan J. Vekich Senior Scientist Aalto Scientific Ltd. 1959 Kellogg Avenue Carlsbad, CA 92008
Re: K032122
Trade/Device Name: Audit™ MicroControl MicroFDTM BNP Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: July 3, 2003 Received: August 6, 2003
Dear Mr. Vekich:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
| 510(k) Number (if known): | K032122 |
|---|---|
| Device Name: | Audit MicroControl MicroFD BNP Control |
Indications For Use:
Audit™ MicroFD™ BNP Control is an assayed bi-level reference control consisting of human plasma based solutions. It is intended to simulate human patient plasma samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for both BNP-32 and NT-proBNP assays.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Cawl C Benson for Jean Cooper. DVM | |
| Division Sign-Off |
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K032122 |
|---|---|
| -------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)