(35 days)
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No
The provided text describes a quality control material for clinical chemistry, which is a standard laboratory consumable. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a quality control material for clinical chemistry, which is used to estimate test precision and detect analytical deviations, not to treat a medical condition.
No.
The device described is a quality control material used to estimate test precision and detect analytical deviations in clinical chemistry, not to diagnose a patient's medical condition.
No
The provided text describes a quality control material for clinical chemistry, which is a physical substance used to verify the accuracy of laboratory tests. It does not describe a software device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is a "quality control material... for clinical chemistry" and is "intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations". This clearly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Function: The device's function is to control the quality of clinical chemistry tests, which are performed in vitro (outside the body) on biological samples.
The lack of information in other sections (Device Description, Image Processing, AI/ML, etc.) does not negate the clear indication in the Intended Use section that this is an IVD.
N/A
Intended Use / Indications for Use
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test sytem to estimate test precision and to detect systematic analytivcal 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 or unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Product codes
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
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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
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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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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES * USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 1 2003
Ms. Tonya Mallory Executive Manager Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237
Re: K030065 Trade/Device Name: Wako NEFA Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Ouality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: January 6, 2003 Received: January 7, 2003
Dear Ms. Mallory:
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. Iisting 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 (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 vours.
Steven Butman
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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Indications for Use:
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test sytem to estimate test precision and to detect systematic analytivcal 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 or unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Proprietary Name: Wako NEFA Linearity Set
Established Registration Number: 1627434
Premarket Notification 510 (k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Han Cooper
(Div
Div. Laboratory Devices
510(k) K030065