(50 days)
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No
The document describes a laboratory quality control material and contains no mention of AI or ML technology.
No
This device is described as a control for laboratory use to monitor the accuracy of laboratory analysis, not to treat a medical condition.
No
The device is described as a "control" material used to "monitor the accuracy and precision of laboratory analysis," rather than to diagnose a condition in a patient. It evaluates the performance of other tests.
No
The device description clearly states "Human Liquid Lipid Control," indicating a physical, liquid-based control material, not software.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use in the laboratory to monitor the accuracy and precision of laboratory analysis." This is a core function of IVD devices, which are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description "NOVA-ONE Lipid Control Human Liquid Lipid Control" indicates it's a control material used in laboratory testing, further supporting its IVD nature.
- Intended User / Care Setting: The intended user is "laboratory," which is the typical setting for IVD testing.
While the document lacks information about performance studies, AI/ML, imaging, or patient details, the core intended use and description clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NOVA-ONE Control is intended for use in the laboratory to monitor the accuracy and rrovit one of the listed constituents. The routine use of quality control materials is an integral part of evaluating the accuracy and precision of laboratory analysis.
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
laboratory
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.
APR - 2 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Alan Posner, Ph. D. Execute Vice President Bioresource Technology Inc. 1531 NW 65th Avenue Fort Lauderdale, FL 33313
K040352 Re: Trade/Device Name: NOVA- ONE Lipid Control Human Liquid Lipid Control Regulation Number: 21 CFR 862.1660 Regulation Name: Ouality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 11, 2004 Received: February 12, 2004
Dear Dr. Posner:
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 vour 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 (OS) 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, MS, DVM.
Yean 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 (if known): K040352
Device Name: NOVA-ONE Lipid Control Human Liquid Lipid Control
Indications For Use:
NOVA-ONE Control is intended for use in the laboratory to monitor the accuracy and rrovit one of the listed constituents. The routine use of quality control materials is an integral part of evaluating the accuracy and precision of laboratory analysis.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Division Sign-Off
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Office of In Vitro Diagnostic
Device Evaluation and Safety
5100k040352