(17 days)
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No
The document describes quality control solutions for blood glucose monitors, which are chemical reagents, not software or hardware incorporating AI/ML.
No
The device is described as an "assayed quality control material" and is "for in vitro diagnostic use ONLY," indicating it is used to verify the performance of blood glucose monitors, not to directly treat a medical condition.
No
Explanation: The device described is a quality control solution used to verify the performance of blood glucose monitors, not a device that directly diagnoses a medical condition. It is for "in vitro diagnostic use," meaning it's used in a laboratory setting (or in this case, a home setting as a control) to test other diagnostic devices, not to diagnose a patient itself.
No
The device description clearly states "Nova Glucose Low/High Level Control Solutions," which are physical solutions used for quality control, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Nova Glucose Low/High Level Control Solutions are for in vitro diagnostic use ONLY."
Additionally, the "Device Description" lists it as "Nova Glucose Low/High Level Control Solutions," which are described as "assayed quality control materials" used to verify the performance of blood glucose monitors. Quality control materials used to verify the performance of diagnostic devices are themselves considered IVDs.
N/A
Intended Use / Indications for Use
Nova Glucose Low/High Level Control Solutions are assayed quality control materials, which are used to verify the performance of BD Logic Blood Glucose Monitor, BD Latitude Diabetes Management System, BD/MiniMed Blood Glucose Monitor, and MiniMed Paradigm Link Blood Glucose Monitor. This control is an OTC product intended for use in the home setting.
The Nova Glucose Low/High Level Control Solutions are for in vitro diagnostic use ONLY.
Product codes (comma separated list FDA assigned to the subject device)
JJX
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
home setting
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 7 2004
Mr. Paul W. Mac Donald Chief Quality and Regulatory Affairs Nova Biomedical Corp. 200 Prospect Street Waltham, MA 02454-9141
K041016 Re:
Trade/Device Name: Nova Glucose Low/High Level Control Solutions Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: April 19, 2004 Received: April 20, 2004
Dear Mr. Mac Donald
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,
Jean M. Cooper, US, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K041016
Device Name:
Nova Glucose Low/High Level Control Solutions
Indications for Use:
Nova Glucose Low/High Level Control Solutions are assayed quality control materials, which are used to verify the performance of BD Logic Blood Glucose Monitor, BD Latitude Diabetes Management System, BD/MiniMed Blood Glucose Monitor, and MiniMed Paradigm Link Blood Glucose Monitor. This control is an OTC product intended for use in the home setting.
The Nova Glucose Low/High Level Control Solutions are for in vitro diagnostic use ONLY.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Posted November 13, 2003)
Albert Sert
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071016